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C. diff. and Recurrent C. diff. infections.
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CLINICAL TRIALS IN PROGRESS ADDRESSING
C.difficile INFECTION PREVENTION AND TREATMENTS.
Da Volterra is a clinical-stage biotechnology company whose vision is to be a trusted and acknowledged leader in the microbiota field. Da Volterra’s mission is to discover, develop, and bring to market safe and novel therapeutic options, preserving patients’ microbiota to prevent and cure life-threatening diseases. Its most advanced product is DAV132, an oral product to be co-administered with any oral and intravenous antibiotics, to protect patients from antibiotic-induced intestinal microbiota disruption. DAV132 can prevent Clostridioides difficile infection by capturing residual antibiotics in the colon before they can disrupt the intestinal microbiota, without impacting the systemic efficacy of the antibiotics.
We see DAV132 as a real game-changer for C. difficile prevention.
Have a look at the DAV132 webpage and video presenting its mechanism of action: https://davolterra.com
The video is highly illustrative of what C. diff. is, how C. diff. is triggered, and how DAV132 could prevent the colonization of the intestinal microbiota by C. diff. and the occurrence of the infection.
Da Volterra has already performed 6 phase 1 clinical trial with DAV132 in healthy volunteers and one phase 2 clinical trial (SHIELD) in patients demonstrating DAV132 favorable safety profile and mechanism of action. The SHIELD study met its primary endpoint: DAV132 was very safe for use in hospitalized patients with several comorbidities and concomitant medications. The study also demonstrated positive results with regards to biological markers of efficacy for prevention of C. difficile infection: DAV132 effectively protected the intestinal microbiota of patients from antibiotic-induced disruption and DAV132 also prevented the proliferation of C. difficile in an ex vivo assay, suggesting that DAV132 is able to protect patients against antibiotic-induced C. difficile infection.
The press release on Da Volterra’s phase 2 SHIELD study results is available here: https://davolterra.com/wp-content/uploads/2020/02/2020-02-11-dav132-phase-2-clinical-trial-pr-vf.pdf
Da Volterra is now preparing for the launch of phase 3 pivotal study of DAV132 in patients who have a high risk of developing Clostridioides difficile infection.
Information on this study is available here: https://clinicaltrials.gov/ct2/show/NCT03710694
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.
i] Clover Trial.
Available from: https://clovertrial.com/en/.
Accessed July 31, 2019.
[ii] Pfizer. Clostridium Difficile Vaccine Efficacy Trial (Clover). In:ClinicalTrials.gov [Internet]. [cited 2019 July 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT03090191. NLM Identifier: NCT03090191.
“Is another C. diff. infection getting in the way of your life?”
Most Clostridioides difficile (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 disrupt the microbiome by killing both good and bad bacteria. 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 inactive forms (i.e. C diff spores) are untouched. When the microbiome is disrupted, these spores turn into active C diff bacteria and cause disease again and again – usually after antibiotic treatment has finished.
Seres Therapeutics is developing an investigational microbiome drug called SER-109. This medicine is being developed to prevent C. diff. from coming back by repairing the microbiome.
Seres is pleased to announce the positive top-line results from its ECOSPOR-III trial reported in August 2020. In a placebo-controlled randomized trial of 182 patients with multiple (> 3) recurrent C. diff. infection, the recurrence rate was significantly reduced from 41.3% in placebo recipients to 11.1% in the SER-109 recipients. In addition, SER-109 was well tolerated.
Based on these encouraging results, Seres is now enrolling an open-label study, in which all participants will receive SER-109. This new study will be open to patients experiencing their first recurrence or multiple recurrences of C. diff. at sites in the US and Canada.
On the serestherapeutics.com website, there is a phrase at the bottom stating “Recurrent
C. diff. study now enrolling”. Readers should click on the LEARN MORE icon to get further information on the study.
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 to prevent the regrowth of C. Difficile.
Why bacterial consortia?
Unlike fecal transplants, which require the 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.
CONSORTIUM (NCT03788434) is a randomized, double-blind placebo-controlled Phase 2 study to evaluate the 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 the 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
Acurx Pharmaceuticals is a privately held, clinical-stage biopharmaceutical company developing a new class of antibiotics for infections cauAcurx Pharmaceuticalssed by bacteria listed as priority pathogens by the World Health Organization, Centers for Disease Control and Prevention, and Food and Drug Administration.
Ibezapolstat (formerly named ACX-362E) is our lead antibiotic candidate. Ibezapolstat is a first-in-class of a new class of Pol IIIC inhibitors which is in clinical development to treat
C. difficile infections or CDI.
Current treatments for CDI infections utilize other mechanisms of action while ibezapolstat is the first antibiotic candidate intended to work by blocking the Pol IIIC enzyme in C. difficile. This enzyme is necessary for the replication of the DNA of the bacterial cell.
Acurx has worked closely with the FDA to obtain FDA “Fast track” designation as well as the designation of ibezapolstat as a qualified infectious disease product, or QIDP, which provides incentives through the GAIN Act including priority review by the FDA, “fast-track” eligibility, and extension of statutory exclusivity periods in the U.S. for an additional 5 years upon FDA marketing approval of the product to treat patients with CDI.
Acurx acquired the worldwide rights to ibezapolstat from GLSynthesis Inc. in February 2018.
C. difficile, aka CDI, is a pathogen listed in the GAIN Act as a pathogen that causes serious or life-threatening infections and the CDC identifies CDI as an urgent need in terms of generating new antibiotics to treat these infections.
The GAIN Act, Title VIII (Sections 801 through 806) of the FDA Safety and Innovation Act, seeks to provide pharmaceutical and biotechnology companies with incentives to encourage the development of new drugs to treat, prevent, detect and diagnose antibiotic-resistant infections. Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant Gram-negative bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia coli species; resistant Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant Enterococcus (VRE); multi-drug resistant tuberculosis; and Clostridium difficile. It extends the length of time an approved drug is free from competition and clarifies the regulatory pathway for new antibiotics.
For more information, please visit the website at wwwacurxpharma.com.
SOURCE Acurx Pharmaceuticals, LLC Updated October 2020
DEINOVE has developed unique and comprehensive expertise in the field of rare bacteria that it can decipher, culture, and optimize to disclose unsuspected possibilities and induce them to produce biobased molecules with activities of interest on an industrial scale. To do so, DEINOVE has been building and documenting since its creation an unparalleled biodiversity bank that it exploits thanks to a unique technological platform in Europe.
This trial is concentrated in the United States. It will take place in two stages:
The results of this clinical trial should be available by the end of 2020.
“The start of this Phase II clinical trial is a significant step forward for DEINOVE and a great hope for patients. We are very proud to provide a potential solution to this unmet medical need and, to this end, work with the best American specialists in this area. The investigation centers are very committed to conducting this trial which, in the event of positive results, will be an important milestone towards the registration of DNV3837,” said Dr. Georges Gaudriault, Scientific Director of DEINOVE.
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, following good manufacturing practices. This batch will be used 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 completed per the agreed specifications.
For more information: http://www.deinove.com/en
Rebiotix Inc., a Ferring Company, is a clinical-stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome.
It is increasingly recognized that the restoration of healthy gut microbiota is necessary for the effective treatment of a large number of challenging diseases.
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 additional RBX2660 treatment. The study’s primary objective is to assess the 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 has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT TM 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 orthopedics. For more information, visit www.FerringUSA.com.
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 a 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:
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.
Finch Therapeutics is a clinical-stage company developing novel microbiome therapeutics to serve patients with serious unmet medical needs. Built on 30 years of translational research at OpenBiome, MIT, University of Minnesota and Dr. Thomas Borody’s work at the Center for Digestive Diseases in Australia, Finch uses its unique Human-First Discovery® platform to develop therapies from microbes that have demonstrated a clinically significant impact on patient outcomes.
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 the recurrence of CDI compared to a placebo. The study is currently enrolling across the United States. This clinical trial (CP101) is in Phase 2.
CP101 is an investigational, oral microbiome drug designed to prevent recurrent CDI by restoring colonization resistance, or the ability of a healthy microbiome to prevent colonization of potential pathogens. CP101 is designed to deliver complete microbiome communities in orally administered, enteric release capsules.
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 TM 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 the recurrence of C. diff…
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 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 a 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: email@example.com
case/control number C.diff. trial : NCT03793686
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