Seres Therapeutics Reports Positive Results From SER-109 Phase 3 ECOSPOR III Study in Recurrent C. difficile Infection

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– SER-109 met Phase 3 primary endpoint, showing a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared to placebo 

– SER-109 was well tolerated, with a safety profile comparable to placebo 

– Efficacy results substantially exceeded FDA regulatory guidance to support BLA filing as a single pivotal trial; Company to meet with the agency to discuss filing for product approval as soon as possible 

 Positive SER-109 Phase 3 data provide validation for Seres’ microbiome therapeutics platform and further development of its pipeline of product candidates 

 Seres Therapeutics, Inc. reported on August 10, 2020, positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study showed that SER-109 administration resulted in a highly statistically significant absolute decrease of 30.2% in the proportion of patients who experienced a recurrence in CDI within eight weeks of administration versus placebo, the study’s primary endpoint. 11.1% of patients administered SER-109 experienced a CDI recurrence, versus 41.3% of placebo patients. The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective.

The study’s efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to placebo.

“We are extremely pleased with these highly clinically meaningful SER-109 Phase 3 study results, greatly exceeding the statistical threshold provided by the FDA. Based on our prior discussions with the FDA, we believe this trial should provide the efficacy basis for submitting an application for product approval. We look forward to meeting with the FDA as soon as possible to discuss the regulatory path forward with the goal of bringing SER-109 to patients as a first-in-class microbiome therapeutic,” said Eric D. Shaff, President and Chief Executive Officer of Seres. “Our results represent the first-ever positive pivotal clinical study results for a targeted microbiome drug candidate. We believe these Phase 3 data provide strong validation for our underlying microbiome therapeutics platform, which has been the scientific basis for the Company, as well as persuasive clinical evidence supporting our other active pipeline programs.”

“We would like to thank all those who participated in this landmark study. Based on these highly positive SER-109 ECOSPOR III results, we believe that this novel microbiome therapeutic candidate could potentially provide a much-needed effective oral treatment option for the approximately 170,000 patients in the U.S. that suffer from recurrent CDI annually,” said Lisa von Moltke, M.D., FCP, Chief Medical Officer of Seres. “Seres applied a data-driven and scientifically rigorous approach to developing SER-109. The proprietary scientific learnings we have obtained continue to drive our overall R&D efforts and the advancement of our other ongoing microbiome therapeutic programs.”

“Recurrent C. difficile infection is a serious disease that devastates patients’ quality of life, and in many severe cases may result in a patient’s death. Today’s treatment options have important shortcomings related to efficacy, safety, and route of administration, and novel approaches that target the root causes of the disease are urgently needed. The SER-109 Phase 3 results are highly impressive and represent an exceptional advance in the fight against this disease. I believe that SER-109 has the potential to fundamentally transform the treatment of recurrent C. difficile infection,” said Mark Wilcox, M.D., Professor of Medical Microbiology, University of Leeds.

ECOSPOR III Study Design and Results

The ECOSPOR III study (ClinicalTrials.gov identifier: NCT03183128) is a multicenter, randomized, placebo-controlled study that enrolled 182 patients with multiply recurrent CDI. Patients were randomized 1:1 to receive either SER-109 or placebo, after standard of care antibiotic treatment. SER-109, or placebo, was administered orally for three consecutive days. All patients were required to have a positive C. difficile toxin diagnostic test both at study entry and in the case of suspected recurrence to ensure the selection of individuals with active disease and to confirm the accuracy of the primary endpoint.

The primary efficacy endpoint of ECOSPOR III was the proportion of patients with recurrent CDI at up to eight weeks following administration of SER-109 or placebo. As a secondary endpoint, patients are evaluated for CDI recurrence through 24 weeks post-treatment, and the Company plans to present those results at a future date.

SER-109 met the study’s primary endpoint with a significantly lower recurrence rate of 11.1% in SER-109 patients versus 41.3% in placebo patients at eight weeks; p<0.001 tested at the one-sided 0.25 level. Patients administered SER-109 experienced a 30.2% lower rate of recurrence, on an absolute basis, compared to placebo. The SER-109 treatment arm relative risk was 0.27 (95% CI=0.15 to 0.51) versus placebo. The ECOSPOR III recurrence rates translate into a sustained clinical response rate of 88.9% versus 58.7% with SER-109 and placebo, respectively. The SER-109 Number Needed to Treat (NNT) was approximately 3.

In prior discussions, the FDA communicated that demonstration of a statistically very persuasive efficacy finding in the ECOSPOR III primary endpoint, defined as demonstrating a 95% upper confidence level of relative risk lower than 0.833, could support a BLA submission on the basis of this single study. The results of ECOSPOR III demonstrated a SER-109 relative risk of 0.27 (95% CI=0.15 to 0.51) compared to the placebo. As a result, Seres believes that this study should support the efficacy basis for BLA submission. SER-109 has obtained FDA Breakthrough Therapy and Orphan Drug designations.

SER-109 was well tolerated, with no treatment-related serious adverse events (SAEs) observed in the active arm, and an adverse event profile similar to placebo. The overall incidence of patients who experienced AEs during the eight-week study period was similar between SER-109 and placebo arms. The most commonly observed treatment-related AEs were flatulence, abdominal distention, and abdominal pain, which were generally mild to moderate in nature, and these were observed at a similar rate in both the SER-109 and placebo arms.

A SER-109 open-label study is ongoing ( clinicaltrials.gov identifier: NCT03183141) at selected clinical sites that participated in the ECOSPOR III study, and the Company may initiate the program at additional clinical sites. The FDA has previously indicated that SER-109 administration to at least 300 patients, consistent with standard FDA guidance, would be required to support BLA submission. The ongoing SER-109 open-label study is continuing to contribute to the SER-109 safety database.

The Company plans to immediately request a Breakthrough Therapy designation meeting with the FDA to discuss the requirements to submit a BLA seeking regulatory approval of SER-109. Given the favorable efficacy and safety results seen in ECOSPOR III, the safety results observed in prior SER-109 clinical studies, and the critical unmet need for a therapeutic option for recurrent CDI patients, the Company plans to discuss with the FDA the safety data requirements for a BLA filing.

Seres continues to advance its commercial readiness for the potential launch of SER-109. In June 2020, Seres appointed Terri Young, Ph.D., R.Ph., as Chief Commercial and Strategy Officer. The Company has been conducting activities to support successful future potential commercialization. Seres believes that the commercial opportunity for SER-109 could be substantial, given the dire need for an effective, safe, oral therapeutic, and the strength of the SER-109 Phase 3 study results.

Conference Call Information

Seres’ management will host a conference call today, August 10, 2020, at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 3216859. Accompanying slides will be posted on the Seres website ahead of the conference call. To join the live webcast, and to view the accompanying slides, please visit the “Investors and Media” section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for approximately 21 days.

About SER-109

SER-109 is an investigational, oral, biologically-derived microbiome therapeutic that is designed to reduce the recurrence of C. difficile infection (CDI), enabling patients to achieve a sustained clinical response by breaking the vicious cycle of CDI recurrence and restoring the diversity of the gastrointestinal microbiome. SER-109 is a consortium of purified bacterial spores of multiple Firmicute species, manufactured by fractionating targeted bacteria from the stool of healthy human donors with further steps to inactivate potential pathogens. The FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of CDI.

SER-109 is fundamentally distinct from fecal microbiota transplantation (FMT). SER-109 is comprised of a highly-purified consortia of spore-based commensal bacteria and designed to be manufactured in accordance with Good Manufacturing Practice conditions using stringent standards to ensure product quality and consistency. To support product safety, Seres utilizes a unique manufacturing process that inactivates numerous potential pathogens, including species of non-spore bacteria, such as Escherichia coli, and viruses such as SARS-CoV-2.

About C. difficile Infection (CDI) and Current Treatments

C. difficile infection (CDI) is one of the top three most urgent antibiotic-resistant bacterial threats in the U.S., according to the Centers for Disease Control, and is a leading cause of hospital-acquired infection in the U.S. It is responsible for the deaths of approximately 20,000 Americans each year. CDI is associated with debilitating diarrhea, which significantly impacts the quality of life in every functional domain. Since the discovery of C. difficile more than four decades ago, vancomycin has been the most commonly used drug for patient management. Current approaches provide only modest improvements in sustained clinical response rates, leaving behind a significant pool of patients with recurrent disease. Unapproved FMT, used in cases that are not responsive to approved drugs, remains poorly characterized clinically and has been associated with serious safety concerns, including the transmission of bacterial pathogens and the potential transmission of viruses such as SARS-CoV-2, the virus that causes COVID-19. The recent quarantine and shipping hold of FMT from a major stool bank highlights the urgent need for an approved effective and safe treatment for recurrent CDI.

About Seres Therapeutics

Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has the potential to become a first-in-class FDA-approved microbiome therapeutic. Seres’ SER-287 program has obtained Fast Track and Orphan Drug designations from the FDA and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for ulcerative colitis and SER-155 to prevent mortality due to gastrointestinal infections, bacteremia, and graft versus host disease. For more information, please visit www.serestherapeutics.com

SOURCE: Seres Therapeutics

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Junior Researchers Focusing on Clostridioiles difficile (C. diff.)

A group of students, also known as the Golden Pandas are an FLL Robotics Team from Westfield, IN who have developed a special interest in helping to fight C. diff.  infections

The team  attended the 2019  – 7th Annual International C. diff. Conference & Health EXPO hosted in St. Louis, MO and were inspired and impacted by all that they learned.

To help the team learn more about a C. diff. infection ~ we are asking patients, C. diff. Survivors, and their families to take a minute and participate in their unique survey.  Your answers will make a difference for others afflicted by this life-threatening infection:

 

 

 

 

 

 

 

The Sporalizer (spore visualizer) is a system that uses specially formulated wipes that will react with C. diff spores, causing them to glow so that hospital cleaning crews can then effectively clean them. The team is hopeful that being able to see germs is the next step in the fight against infections.

You can learn more and reach out to the team at https://www.youtube.com/watch?v=rKs_GiYjdN4 or https://instagram.com/sporalizer/ or visit their website www.sporalizer.com

 

C. diff. (CDI) Treatment and Prevention Options Through Clinical Trials

Every scientific research and development, every clinical trial in progress is a glimmer of hope………..HOPE for clinically safe and approved avenues to prevent and treat a C. difficile infection.

Listed below you will find a few examples of  organizations who have active
C. difficile Prevention and Treatment clinical trials in progress.  Click on each organization’s website listed to review their clinical trial study opportunities and inquire if you or your loved one qualify to participate in their study. 

 

To Learn More About Clinical Trials —

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Learn more About Clinical Studies and About This Site, including relevant History, Policies, and Laws.  Click on the link below to be redirected to the clinicaltrials.gov website: https://clinicaltrials.gov/

Clinical Studies Are In Progress To

Help Them — Help You — Help Others  ♥

Here is a partial-listing and explanations of Clinical Trial Phases:

Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.

  • Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

THE FOLLOWING ARE A FEW EXAMPLES OF CLINICAL TRIALS AVAILABLE ADDRESSING C.difficile INFECTION PREVENTION AND TREATMENTS. 

Visit clinicaltrials.gov for a full listing.

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  C. diff. Infection (CDI)_Prevention Clinical Studies

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DAV-Logo (2)

Da Volterra is a is a clinical stage biotechnology company whose vision is to be a trusted and acknowledged leader in the microbiota field. Our mission is to discover, develop and bring to market safe and novel therapeutic options, preserving patients’ microbiota to prevent and cure life-threatening diseases. Our most advanced product is DAV132, an oral product to be co-administered with any antibiotics, in order to protect patients from antibiotic-induced intestinal microbiota disruption. DAV132 decreases the risk of triggering Clostridium difficile infection by inactivating residual antibiotics in the colon
before they can disrupt the bacterial flora, without impacting the systemic efficacy of the antibiotics.

It is noteworthy that DAV132 is developed to accompany all oral and intravenous antibiotics of any class and would therefore significantly reduce the risks to acquire C.difficile infections for patients at risk. We see DAV132 as a real game changer for C.difficile prevention.

Have a look at DAV132 webpage and video presenting its mechanism of action: https://davolterra.com
The video is highly illustrative of what C.diff is and how C.diff is triggered.

We have already performed 4 clinical trials with DAV132 in healthy volunteers and we have a very exciting dataset (both preclinical and clinical) suggesting that DAV132 will very effectively prevent C.diff infections. We are currently conducting a clinical trial, in patients actually treated with antibiotics and at-risk of C.diff.             

Information on this study is available here: https://clinicaltrials.gov/ct2/show/NCT03710694

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Pfizer, a leader in vaccine research and innovation, continues to advance its Clostridium difficile (C. difficile) vaccine candidate, PF-06425090. The Phase 3 trial CLOstridium difficile Vaccine Efficacy TRial (CLOVER), is an ongoing placebo-controlled trial designed to assess whether PF-06425090 prevents the disease, and whether it is safe and well-tolerated in adults 50 years of age and older. [i], [ii]

Additional information about CLOVER can be found at CloverTrial.com.

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Seres Therapeutics

“Is another C. diff.  infection getting in the way of your life?”

Seres Therapeutics is developing Ecobiotic® drugs designed to prevent C diff infections from coming back again.

Most C diff infections occur after antibiotic treatment. Why? Our gut contains trillions of microbes, called the microbiome, which protects us from bacterial invaders that can cause disease. Antibiotics kill both good and bad bacteria, leaving holes in this ecology (community) of microbes. When the microbiome is damaged, bad bacteria, like C diff, can take advantage and cause disease. Although specific antibiotics can kill the active C diff bacteria, the sleeping forms (ie, spores) are untouched. These spores turn into active C diff bacteria and cause disease again and again – usually after antibiotic treatment has finished.

Seres Therapeutics has developed an oral medicine called SER-109, which aims to prevent C diff from coming back by repairing the microbiome. This Ecobiotic® drug is being studied in a large Phase 3 clinical trial that is enrolling patients who have had multiple C diff infections. This important clinical study is being done in the United States and Canada and may provide the final clinical data needed to support FDA and Canadian drug approvals.

To learn more about Seres Therapeutics and Clinical Trials In Progress please click on the following link to be redirected:

www.serestherapeutics.com

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Vedanta Biosciences, Inc. is a clinical-stage microbiome company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria.

VE303 is a defined bacterial consortium designed to prevent recurrent C. difficile infections (“CDI”).  VE303 is a preparation of eight different bacteria that were selected for their presumed ability of preventing regrowth of C. Difficile.

Why bacterial consortia?

Unlike fecal transplants, which require use of donors’ stool and are an inherently variable procedure, bacterial consortia therapeutics are defined drug compositions produced from clonally isolated bacteria that can trigger targeted immune responses. And unlike reductionistic approaches such as single strain probiotics, they can robustly shift the gut ecosystem.

The results of the Phase 1 study of VE303 showed both rapid expansion of protective VE303 bacteria in the gut and accelerated recovery to a healthy microbiome after disruption to the normal microbiome in the gut caused by antibiotics.  Based on these Phase 1 results, Vedanta is now evaluating VE303 (the “CONSORTIUM” study) in individuals with CDI to see if it can prevent future CDI recurrences by restoring the intestinal bacteria to a healthy state.

About

CONSORTIUM (NCT03788434) is a randomized, double-blind placebo-controlled Phase 2 study to evaluate safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) and efficacy of VE303 in patients with a recent diagnosis of CDI, who have completed a course of antibiotics but remain at risk for recurrence. The primary endpoint will be prevention of infection recurrence at eight weeks.

CONSORTIUM is currently enrolling participants across North America (U.S. and Canada) who have been diagnosed with high-risk CDI.

For additional study information or to locate a study site near you, please visit Clinicaltrials.gov:

https://www.clinicaltrials.gov/ct2/show/NCT03788434

If you have questions about the study or are interested in study participation, please email:

Consortium02-ctinquiries@vedantabio.com

 

Please take a moment to view a brief presentation, created by Vedanta Biosciences, to learn more about
C. difficile infections, treatments, and clinical trials
https://f.io/oRC8HkFV

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Valneva Clinical Trial of its Clostridium difficile vaccine candidate

UPDATE:  February 2019

Valneva’s Clostridium difficile vaccine candidate – VLA84

Valneva successfully completed Phase 2 development of its prophylactic vaccine candidate against Clostridium difficile infection, confirming previously announced positive topline data. The vaccine candidate VLA84 is Phase 3 ready.

Valneva seeks to partner its Clostridium difficile vaccine candidate. At this point, however, potential partners are hesitant about the level of investment required to fund a Phase 3 clinical trial. Therefore, the Company reviewed its development and partnering approach. Valneva will consider using the first CDI vaccine approval and to conduct a head to head, non-inferiority Phase 3 trial, based on an immunological correlate that is expected to substantially improve the investment – risk profile of an in-house, or partnered, development to market.

The Company estimates that the total market potential for prophylactic C. difficile products may exceed $1 billion annually.

 

BACKGROUND:    Lyon (France), December 18, 2014European biotechnology company Valneva SE (“Valneva”) announced today the initiation of the Phase II clinical trial of its VLA84 prophylactic vaccine candidate against Clostridium difficile (C. difficile), the main cause of nosocomial diarrhea. Data from the Phase I study in healthy elderly and adults showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies, supporting the Company`s decision to progress the vaccine
candidate into Phase II

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C. diff. Infection (CDI) Treatments

Clinical Studies

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Acurx Pharmaceuticals, LLC  a privately held, clinical-stage, a biopharmaceutical company developing new antibiotics for difficult-to-treat bacterial infections, announced that its lead product candidate, ACX-362E, has successfully completed the 68-subject, double-blind, placebo-controlled, multiple-ascending dose Phase 1 clinical trial of ACX-362E in healthy volunteers.  The Phase 1 clinical trial was first-in-man for a new class of antibiotics that work by inhibiting DNA synthesis in certain bacterial cells (pol IIIC inhibitors).  Pol IIIC is required for DNA replication of many Gram-positive pathogens, including  Clostridioides as well as Enterococcus, Staphylococcus, and Streptococcus.  Multiple-dose levels up to 450 mg BID for 10 days were shown to be well tolerated. Any adverse events attributed to ACX-362E were mild, transitory, and did not interrupt treatment in any subject. Blood levels of ACX-362E show low systemic exposure,  indicating poor oral absorption and desirable in treating CDI.  Additionally, fecal concentrations of ACX-362E at higher dose levels rapidly exceeded the concentrations known to inhibit C. difficile by several hundred-fold and were sustained for the duration of the 10-day treatment period.

ACX-362E is a novel, oral antibacterial agent for the treatment of Clostridioides difficile infection (CDI), an acute, serious, potentially life-threatening, intestinal infection. This Phase 1 study included a 6-subject vancomycin treatment arm (the current standard of care for CDI) for comparative microbiome analysis by Dr. Kevin Garey, Professor, University of Houston College of Pharmacy and Principal Investigator for this aspect of the trial.  ACX-362E effects on the fecal microbiome were compared to those produced by vancomycin over the 10-day treatment course. The results demonstrate that while vancomycin significantly disrupts Bacteroidetes and Firmicutes, deemed to constitute more than 80% of the favorable microbiota in the gastrointestinal tract, ACX-362E had minimal impact on the Bacteroidetes and Firmicutes.  Specifically, vancomycin treatment resulted in a 3-4 log reduction in Bacteroides while ACX-362E doses of 300 or 450 mg BID showed minimal effect.

About the Phase 1 Clinical Trial
The Phase 1 trial was a double-blind, placebo-controlled study to determine safety, tolerability, pharmacokinetics and fecal concentrations of ACX-362E in healthy volunteers conducted in the U.S.  A total of 68 subjects, of which 44 were given active drug, were enrolled in 3 parts: Part 1, Single-ascending dose (n = 32); 6 active/2 placebo per dose cohorts of 150, 300, 600, and 900 mg; Part 2: Food-effect crossover at 300 mg (n = 8); Part 3: Multiple-ascending dose (n = 22); 6 active/2 placebo per dose cohort; BID dosing x10 days; 30-day follow-up visit for microbiome sampling; dose cohorts of 300 and 450 mg.  Additionally, it included an “Active” control group for microbiome studies, oral vancomycin q6H x10 days (n = 6)

Safety information was analyzed through assessment of adverse events and other standard safety measures, while concentrations of ACX-362E were determined in both the blood and the feces, the latter being the critical site of drug delivery for treating CDI.  In addition, Acurx partnered with Dr. Kevin Garey’s laboratory at the University of Houston to perform state-of-the-art microbiome testing of gastrointestinal flora in trial subjects.

.For more information, please visit our website at wwwacurxpharma.com.

View original content:http://www.prnewswire.com/news-releases/acurx-successfully-completes-ph1-clinical-trial-for-acx-362e-in-cdi-300908613.html

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  • Having reached a sufficient number of clinical centers, Phase II clinical trial testing the antibiotic candidate DNV3837 in Clostridioides[1] (Clostridium) difficile infections will start this summer in the United States and Germany 
  • This trial will be conducted as part of an active Investigational New Drug (IND) authorization and a recently updated version of the clinical protocol
  • The production of the first commercial batch of DNV3837 has been successfully initiated

DEINOVE (Euronext Growth Paris: ALDEI), a French biotech company that uses a disruptive approach to develop innovative antibiotics and bio-based active ingredients for cosmetics and nutrition, announced that all the conditions are in place for the upcoming start of the Phase II trial testing the antibiotic candidate DNV3837 for the treatment of Clostridioides difficile infections.

DNV3837 is a first-in-class antibiotic candidate targeting the treatment of Clostridioides difficile infections (CDIs), a disease classified as a priority by the WHO and one of the global leading causes of healthcare-related infections[2]. DNV3837 has demonstrated a promising efficacy profile, an acceptable tolerance in Phase I trials. It has obtained a QIDP designation and a Fast Track status[

DNV3837 will now enter Phase II trial for the treatment of CDIs. The clinical protocol has recently been adjusted and allows the trial to be conducted under the IND initially granted for the compound.

This multicentric open-label trial will be conducted both in Germany and the United States. Under the updated protocol, the number of sites, necessary for the implementation of its Phase II, has been reached. The inclusion of the first patient is planned for mid-2019. Medpace (Nasdaq: MEDP) was chosen as the Clinical Research Organization to oversee the trial.

In parallel, DEINOVE has started the production of the first DNV3837 batch on a commercial scale, in accordance with good manufacturing practices. This batch will be used in order to prepare enough material for conducting Phase III trial. CMC (Chemistry, Manufacturing, and Controls) operations in the United States have been contracted to a recognized CMO and the first production steps have been successfully completed in accordance with the agreed specifications.

For more information:  http://www.deinove.com/en

 

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Study: Bezlotoxumab Versus Placebo in Children With Clostridium difficile Infection (CDI) (MODIFY III)

Recruitment Status: Recruiting

The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab in children aged 1 to <18 years with a confirmed diagnosis of CDI who are receiving antibacterial drug treatment for this infection. (Source = ClinicalTrials.gov)

Click here to learn more about this study

Click here to see if there’s a site near you

 For Additional Site and Study Information:

Toll-Free: 1-888-577-8839

Email: Trialsites@merck.com

 ZINPLAVA™ (bezlotoxumab):

ZINPLAVA is a prescription medicine used to help decrease the risk of C-diff from coming back in people 18 years of age or older who are taking an antibiotic for C-diff and who have a high risk of C-diff coming back. C-diff is a bacterial infection that can damage your colon and cause stomach pain and severe diarrhea.

When people get C-diff, they often take an antibiotic to get rid of the infection. Even when treated by an antibiotic, C-diff can come back within weeks to months. ZINPLAVA helps to decrease the risk of the infection from coming back. It works when given along with the antibiotic that you are taking to treat C-diff. (Source = zinplava.com)

Click here to learn more about ZINPLAVA (bezlotoxumab)

 Study Sponsor: Merck

 

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Rebiotix Inc. is a clinical-stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. Microbiota Restoration Therapy (MRT) is the company’s platform for delivering live microbes into a sick patient’s intestinal tract to treat disease.

Study:

The PUNCH CD3-OLS study is a Phase 3 clinical study to assess the safety and tolerability of Rebiotix RBX2660 for the prevention of recurrent Clostridium difficile infection (CDI) in a recurrent CDI population that is broader and more inclusive than that included in prior studies using RBX2660.

This open-label study is expected to enroll up to 200 patients at 80 research sites in the U.S. and Canada. Patients that meet the study requirements and choose to enroll will receive RBX2660, an investigational new drug (no placebo). Study patients whose CDI returns within 8 weeks after study treatment may be scheduled to receive an additional RBX2660 treatment. The study’s primary objective is to assess safety and tolerability of RBX2660 through 6 months after the final RBX2660 study treatment.

Additional information can be found  on the Clinicaltrials.gov website  https://clinicaltrials.gov/ct2/show/NCT03931941

Or through the Rebiotix website: https://www.rebiotix.com/

Rebiotix Inc., part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The MRT platform is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. The lead drug candidate, RBX2660, is currently in Phase 3 clinical development for the prevention of recurrent Clostridium difficile(C. diff) infection. RBX2660 has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the US FDA for its potential to prevent recurrent C. diff infection. Rebiotix’s clinical pipeline also features RBX7455, a lyophilized, non-frozen, oral capsule part of a recently completed investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff infection. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, women’s health, urology, gastroenterology, endocrinology, oncology, and orthopaedics. For more information,  visit www.FerringUSA.com.

 

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Summit Therapeutics  Ridinilazole is being developed by Summit Therapeutics as a potential treatment for
C. difficile infection (CDI). It’s a new antibiotic, and Summit is testing whether it can improve patient outcomes over the current standard of care, vancomycin, in two global clinical trials. In an earlier clinical trial in patients with CDI, ridinilazole was found to be superior to vancomycin in a measure called sustained clinical response, which tested if patients were cured after treatment and did not experience a recurrence within 30-days post-treatment. More information on ridinilazole can be found by visiting www.summitplc.com

Some key information about the trials:

  • Each trial is expected to enroll up to 680 patients
  • Patients will be randomized to receive either ridinilazole or vancomycin, and neither the patients nor the study doctors will know which drug they receive
  • Participation will involve about 7 study visits over approximately 100 days to track the safety and effectiveness of each drug
  • Patients who participate may be reimbursed for travel expenses associated with study site visits
  • Patients must be 18 years of age or older
  • Patients must have signs and symptoms of CDI, including diarrhea, in the 24 hours prior to entry in the trial and a positive toxin test on a stool sample produced within 72 hours of entry into the trial
  • Patients cannot have had more than one prior episode of CDI in the previous three months or more than three episodes in the past 12 months
  • Patients cannot have had more than 24 hours of CDI antibiotic treatment prior to entry into the trial
  • There are additional entry criteria and considerations; the study doctors will ultimately decide whether a patient is eligible for entry into the clinical trials and the patient will be required to give consent

Further details of the global clinical trials can be found by visiting: https://clinicaltrials.gov/ct2/show/NCT03595566 and https://clinicaltrials.gov/ct2/show/NCT03595553, and/or by speaking with one of the clinical trial sites.

The clinical trials will be taking place at sites in the US, Europe, Latin America, Australia and Asia. If you would like to be considered for enrollment into one of the clinical trials, please contact the study site nearest you.

ridinilazole has already received Qualified Infectious Disease Product, or QIDP, designation and has been granted Fast Track status from the US Food and Drug Administration

To learn more about ridinilazole and Summit Therapeutics, click on the following link

to be redirected to the Summit Therapeutics website:  https://www.summitplc.com/

Visit www.ricodify.com online resources for patients with CDI and their caregivers.  The website also includes a map of clinical sites, which is searchable by postcode.

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In October of 2017, Finch merged with Crestovo to form Finch Therapeutics Group.

The PRISM 3 clinical study is for patients who have had a recurrence of Clostridium difficile infection (CDI or C. diff). The study is evaluating the safety and effectiveness of the study drug (CP101) to prevent recurrence of CDI compared to a placebo. The study is currently enrolling across the United States.

This clinical trial (CP101) is in Phase 2.  For more information from
http://www.ClinicalTrials.gov  click on the following link:

https://www.clinicaltrials.gov/ct2/show/NCT03110133?term=PRISM+3&rank=3

The study drug, CP101, is a Full-Spectrum Microbiota™ investigational drug designed to deliver bacteria to the intestine. This bacteria may help overtake the surplus of C. diff. bacteria that cause CDI.

CP101 is encapsulated for oral administration. The powder is intended to be released from the capsules in the right part of your intestine where the bacteria may repopulate. This may aid in restoring the diverse community of bacteria found in the healthy human gut, which may prevent recurrence of C. diff..

Click here to learn more about PRISM 3 (https://www.prism3trial.com/trial) and see if there is a study near you and if you are eligible.

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CP101 drug products are in development and investigational at this time. No product has yet been approved by the U.S. Food and Drug Administration. Prolacta Bioscience is a company dedicated to Advancing the Science of Human Milk. It has been leading the way in developing human milk-based nutritional products for premature and other infants with special nutritional needs since 2005.

Prolacta has recently developed a potential therapeutic, consisting of beneficial components derived from human milk and is investigating its usefulness in the treatment of C. difficile associated diarrhea.  In a healthy individual, the bacteria population living in the gut (microbiome) provides many health benefits and can prevent pathogens from causing infections. Antibiotics wipe out the beneficial bacteria in the gut and can allow harmful bacteria such as C. difficile to overgrow.

C. difficile causes disease by producing toxins that injure the cells of the gut wall. Although some specific antibiotics can cure C. difficile infections, at times the pathogen can resist antibiotics by forming spores. These C. difficile spores are immune to the effects of antibiotics and, under certain conditions, can become harmful active bacteria, which start the disease cycle all over again. If the gut microbiome does not return to a healthy state, the C. difficile infection may still return after each antibiotic treatment.

Prolacta’s new product has natural biological activities that could help restore the individual’s healthy gut microbiome and support immune function in order to potentially reduce the risk of a relapse of C. difficile disease without having to introduce a new bacterial population collected from outside sources.

Some Key Information about the trial:
• Patients will be given liquid product (consisting of human milk-derived components) or placebo, administered orally three times daily for seven days
• Phase I Study
• Double-blind, randomized, placebo-controlled dose escalation trial
• Study subjects will receive one of three doses depending upon which dose group is recruiting at the time of their participation.
• Currently enrolling patients age 18 or older who have had no more than four prior occurrences of C. difficile associated diarrhea (CDAD) and are currently being treated with standard of care antibiotics.
• The target enrollment number is between 48 and 54.

The clinical trial will be taking place at the following locations in the US:
– Idaho Falls, ID Orlando, FL
– Butte, MT Miami-Dade, FL
– Omaha, NE Tampa, FL
– Ventura, CA New York, NY
For further information contact:  info@prolacta.com

case/control number C.diff. trial : NCT03793686

clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT03793686?term=Prolacta&rank=3

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2/2019 :  A PARTIAL LIST OF CLINICAL TRIALS UPCOMING

AND

CLINICAL TRIALS CURRENTLY ENROLLING —  FOR THE FULL LISTING VISIT clinicaltrials.gov

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An Opportunity For C. diff. Survivors To Discuss Their CDI Journey That Will In Turn Help Others

 

We’d love for C. diff. Survivors to describe any history that may have led to the C. diff. infection  (CDI) (e.g. taking antibiotics just prior?), the diagnosis – particularly how long this took and any specialists that had to be involved, the various treatments involved and most importantly, the impact it had on you, your family, your daily life and any lasting effects, with the Summit Therapeutics organization.

 

♥ HELP THEM TO HELP OTHERS ♥

 

If you are interested in volunteering to discuss YOUR journey and information with the Summit Therapeutics organization, please contact:

Michelle Avery, Senior Director Investor Relations & Patient Engagement

Summit Therapeutics

Michelle.Avery@summitplc.com

D +1 -617 225 4455

 

C. difficile Infection (C. diff.); A Survivor’s Perspective with CDI Introduction by Teena Chopra, MD,MPH,FACP,FIDSA,FSHEA

Join us on Tuesday, May 26th at 1:00 p.m. EST

C. diff. Spores and More Live Broadcast

www.cdiffradio.com

With Doctor Teena Chopra, MD,MPH,FACP,FIDSA,FSHEA
Associate Professor of Medicine,Division of Infectious Diseases,
Corporate Medical Director,Infection Prevention,Epidemiology,and Antibiotic Stewardship ,DMC and WSU Director,Infection Prevention,Epidemiology and Antibiotic Stewardship,Vibra Hospital

 

Dr. Chopra will lead the discussion with an overview of a C. difficile infection followed by Alba Muhlfeld, and Renata Johnson, C. diff. Survivors both sharing their journey and providing key-points to our global listeners.

 

Unable to listen to the live broadcast?

Access the C. diff. Spores and More Library
www.cdiffradio.com
and listen at your leisure.

 

 

 

C. diff. Spores and More is sponsored by

CDC’s 2018 National and State Healthcare-Associated Infection Progress Report Published

The CDC published the 2018 National and State Healthcare-Associated Infection (HAI) Progress Report showing significant progress nationally  in reducing several hospital-acquired infections and highlighting that prevention of these infections is possible. CDC’s HAI Progress Report is a snapshot of how each state and the country are doing in eliminating the infections outlined in the HAI National Action Plan.

 

 

 

Using data from CDC’s National Healthcare Safety Network (NHSN), the 2018 HAI Progress Report shows the following reductions have been achieved nationally among acute care hospitals (2017 – 2018):

  • About 9% decrease in central line-associated bloodstream infections (CLABSIs)
  • About 8% decrease in catheter-associated urinary tract infections (CAUTIs)
  • No significant changes in ventilator-associated events (VAEs)
  • No significant changes in surgical site infections (SSIs) related to the 10 procedures tracked in the report
  • No significant changes in hospital-onset methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections
  • About 12% decrease in hospital-onset C. difficile infections

 

Each day, approximately 1 in 31 U.S. patients have at least one infection in association with his or her hospital care, underscoring the need for improvements in patient care practices in U.S. healthcare facilities.

While much progress has been made, more needs to be done to prevent healthcare-associated infections in a variety of settings. Ongoing collaboration between public health, healthcare professionals, and other partners serve as a critical component to ensuring patient safety.

 

Additionally, the HAI Progress Report data are now available in CDC’s new Antibiotic Resistance & Patient Safety Portal (AR&PSP), an interactive web-based application that was created to innovatively display data collected through CDC’s NHSN and other sources.  We hope you’ll use the AR&PSP to view enhanced data visualizations on Antibiotic Resistance, Use, and Stewardship datasets as well as HAI data for the nation and states.

NOVEMBER Is C. diff. Awareness Month; Share the Information and Save Lives Worldwide

November is Clostridioides difficile (formally known as Clostridium difficile)  Awareness Month and it is our time to make a difference!  Most patients and their families, until their diagnosis, were not familiar with this infectious disease.  When they tell their friends and family, those friends and family have never heard of a C. difficile (Clostridioides diffiicle, C. diff., CDI)  infection before either.

Sometimes, even when they are told by their doctors of this diagnosis, the doctors can be largely unfamiliar with the impact of this infection and the treatments readily available. This is astonishing. Why? Because a C. diff. infection impacts individuals differently today than it did decades ago.  The re-occurrence rate is greater today than it was in previous years.  Because C.difficile infections are not only acquired by a hospital stay and can be community-acquired. It is a global infection and not isolated in the senior population, however; seniors remain with the higher risk of acquiring this infection.

That’s something people should know about C. diff. — Over 41 individuals lose their life to a Clostridioides difficile infection in the United States of America alone every day — It has no boundaries — It can be acquired by anyone –  at any location and at any age.

Every year we work together to change the awareness of C. diff.  worldwide. Every year we make a difference. Every day of every year we share information through education and advocacy for patients and continue to raise awareness of Clostridioides difficile infection (C. diff., C. difficile, CDI) prevention, treatments, clinical trials, and environmental safety  — further than the day before.

“None of us can do this alone – All of us can do this together.”

Clostridioides difficile (C. diff. C. difficile, CDI) has had an immeasurable impact on our families, in our communities, in our countries.  It is a leading Healthcare-associated infection (HAI) yet awareness of Clostridioides difficile remains quite low among the general public worldwide.

Help us change this.  Contact us and join us TODAY!

Take Action

  • Draft a letter to your State Governor requesting a Proclamation for November dedicated for promoting Clostridium difficile Infection Awareness.
  • Create Your Own Fundraiser!
  • Contact kathy@cdifffoundation.org to get started on the fundraiser of your choice.

Awareness Tools

  • Share the C Diff Foundation brochure  (request your copies by e-mail)  A great guide to explain details about a C. diff. infection and data on C. diff. prevention, treatments, and environmental safety available.
  • The Clinical Trials Page showcases Clostridium difficile prevention and treatment clinical trials available and research-driven results.
  • Personal Stories on C. diff. Survivors Alliance  allow you to share your story, to help raise awareness about C. difficile infections, and to help raise funds for C Diff Foundation www.cdifffoundation.org
  • Share  C.diff. Global Community Support session information which is FREE and available across the USA and accessible from 57 countries to learn more about a C. diff. infection, Nutrition, and to speak with health care providers and fellow-C.diff. survivors to gain knowledge and have questions answered.

Social Media Involvement

Please join us and share YOUR story. Use these November Awareness campaign hashtags to spread awareness for November Is Clostridioides difficile (Clostridium difficile, C.diff., C.difficile, CDI) Infection Awareness Month.

#CdiffInfectionAwareness

(Facebook)  (Twitter)

#CdiffNovemberAwareness

(Facebook)  (Twitter)

 

Clinical Trial Awareness; Treating and Preventing a C.diff. Infection

 

 

 

C. diff. Spores and More Radio guest,
Sarah Mische, PhD discussed the value and importance of Clinical Trials worldwide.  Listen at your leisure and learn about the different phases, the efficacy, patient safety, and research and development that begins the process. Clinical Trials have a beginning, evaluations, FDA meetings, with time well spent by dedicated Science professionals, Clinicians, Health care Providers, and the individuals who are accepted to participate in the studies. It is an educational episode you won’t want to miss! Listen in and learn how we can Help them – to Help you – to Help others.

https://www.voiceamerica.com/episode/109202/clinical-trial-awarenesstreating-and-preventing-cdiff-infection

 

 

http://www.cdiffradio.com

 

Risk Factors and Complications of Pneumonia in Seniors

Risk Factors and Complications of Pneumonia in the Elderly

Pneumonia is the leading cause of death due to infectious disease in the elderly and the 4th most common cause of death in the USA overall. Pneumonia also remains the second most frequent healthcare-acquired infection (HAI).  Statistics show the two groups most at risk are children under the age of five and in older adults over the age of 65. There are various complications that arise from pneumonia and developing in the geriatric population;;  Clostridium difficile Infection (C.diff.) which results in severe G.I.  distress with symptoms of watery stools (diarrhea) of three or more episodes within twenty-four hours. abdominal cramping, fever, nausea.

What are the symptoms of Pneumonia?

The signs and symptoms of pneumonia vary from mild to severe, depending on factors such as the type of germ causing the infection, and your age and overall health. Mild signs and symptoms often are similar to those of a cold or flu, but they last longer.

Signs and symptoms of pneumonia may include:

  • Chest pain when you breathe or cough
  • Confusion or changes in mental awareness (in adults age 65 and older)
  • Cough, which may produce phlegm
  • Fatigue
  • Fever, sweating and shaking chills
  • Lower than normal body temperature (in adults older than age 65 and people with weak immune systems)
  • Nausea, vomiting or diarrhea
  • Shortness of breath

Newborns and infants may not show any sign of the infection. Or they may vomit, have a fever and cough, appear restless or tired and without energy, or have difficulty breathing and eating.

Recent empirical evidence noted the co-occurrence of pneumonia with C.diff. among the elderly in the USA, commonly found due to the recent use of antibiotics and a C.diff. infection can develop within ninety days post-antibiotic therapy. Pneumonia misdiagnosis and inappropriate use of antimicrobial therapy to treat viral vs bacterial infections, are often associated with C.diff. outbreaks among the elderly.  In order to minimize the risk of the elderly contracting both pneumonia and the complications that relate to it, it is important to first and foremost understand  antibiotic therapy, the infection being treated and always discussing antibiotics with the healthcare providers before initiating treatment.  This course of action may prevent the elderly, who are more at risk,  of contracting this life-threatening respiratory disease and the complications that can arise.


Why is the senior population more at risk in developing pneumonia?

Frailty

Seniors are simply frailer than their younger counterparts.  Frailty, however, doesn’t boil down to a single disease or diagnosis. One study outlines the condition as a combined decline across a number of physiological systems which cause a decreased resistance to general environmental stress.  One such common marker of frailty among the elderly is muscular weakness which can directly affect an individual’s ability to clear secretions from the lungs and subsequently avoid infection. It is due to the frail nature of the elderly that it is of vital importance to have effective life saving systems in place to assist both the elderly and their caretakers in times of need.

Compromised immune systems and senior health conditions

As we age our immune systems weaken, making it harder for us to fight off infections such as pneumonia. In addition to this, some drugs such as steroids as well as chemotherapy can further suppress immune responses.  Seniors may suffer from conditions such as heart disease, Diabetes and Alzheimer’s which also puts them at a greater risk along with lung conditions such as Asthma, Chronic Obstructive Pulmonary Disease  (COPD) Cystic Fibrosis,  to name a few diagnosis that directly contribute to the elevated risk of developing Pneumonia.

Surgery

Seniors who have had surgery are more susceptible to pneumonia since their bodies are already working very hard to heal. Pain medications are often prescribed following surgical procedures but they can interfere with a patient’s breathing, causing them to take shallower breaths which in turn cause mucus to gather in the lungs.  The same applies to the use of sedative medicine and anesthesia.

Adults over the age of 65 fall into a high-risk group for both Pneumonia and acquiring a C.diff. infection and should seek medical attention as soon as any symptoms are present.  For some senior adults, especially those with underlying medical conditions such as chronic lung diseases and heart failure, pneumonia can very quickly become a life-threatening condition, underlining the importance of medical intervention as early as possible.

 

Article Donated by Guest Author – Lucy Wyndham

Edited by C Diff Foundation Staff Writers.

References:

https://www.mayoclinic.org/diseases-conditions/pneumonia/symptoms-causes/syc-20354204

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4487835/

https://www.mayoclinic.org/diseases-conditions/pneumonia/symptoms-causes/syc-20354204

Sandra Hay Bryson A Dedication and Memorial Page

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Sandra Hay Bryson

Our beloved mother, wife, sister, aunt, and friend was tragically and suddenly taken from us on the
19th of December 2007 at a young age of 50 after a routine operation and then acquiring a C.diff. infection,  leading to her death 4 days later.

I am Lesley, daughter of Sandra Hay Bryson, and I have decided to join a team and push myself physically, mentally, and emotionally by stepping completely outside of my comfort zone and participating in ‘Tough Mudder’  in
June 2018 . I will be running in my Mum’s memory and to help ‘Raise C.diff. Awareness.’

 

 

 

 

 

Your  show of support with a donation will be greatly appreciated to help promote C.diff. Awareness’ worldwide with the C Diff Foundation, a 501(c) (3)  non-profit global organization, established in 2012, and comprised of 100% volunteering professionals dedicated at supporting public health through education and advocating for
C. difficile infection (CDI) prevention, treatments, environmental safety, and support worldwide.