THE FOLLOWING IS A SHORTLIST OF EXAMPLES OF ORGANIZATIONS WITH CLINICAL TRIALS IN PROGRESS ADDRESSING C. difficile INFECTION PREVENTION AND TREATMENTS. 

Visit clinicaltrials.gov for a full listing.

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 a 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

Seres Therapeutics

"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, a Phase 3 trial, reported in August 2020, met its primary endpoint and showed that SER-109 significantly decreased the chance of a recurrence of C. diff in patients who’d had multiple recurrences. Approximately 88% of patients who received SER-109 did not experience a recurrence, compared to approximately 60% of patients who received placebo.

As part of its sustained commitment to patients, Seres may be able to provide access to its investigational drug, SER-109, under certain limited conditions, through its Expanded Access Program (EAP). Seres’ main objective when initiating an EAP is to equitably serve the patient community with compassion and dignity. Seres aims to accomplish this by thoughtfully balancing requests for treatment with the need to protect patient safety and ensure ethical and compliant access to medications. For more information about SER-109 Expanded Access Program, please visit https://www.serestherapeutics.com, then click on “Patients and Physicians” and scroll down to Expanded Access/Compassionate Use. 

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.

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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 reductionist 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 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 more information visit our website: https://www.vedantabio.com/

Artugen Therapeutics

About

Artugen is developing a novel oral Live Biotherapeutic Product for the prevention of 

C. difficile infection recurrence. The investigational drug, ART24 capsules, is composed of freeze-dried gut-derived bacteria called Bacillus amyloliquefaciens which acts directly against the 

C. difficile bacteria. ART24-1-001 is a blinded study for people with a recent C. difficile infection (first episode or recurrent infection). The study is to see how well ART24 is tolerated and how well ART24 can help prevent future episodes of C. difficile infection compared with placebo. 

You may be eligible to participate in ART24-1-001 if you meet these criteria*:

· Greater than or equal to 18 years of age 

· Currently taking or have recently finished (within the last 6 days) taking antibiotics for a 

C. difficile infection

· Do not have inflammatory bowel disease (IBD)

*Other criteria will also apply.

All eligible participants will receive:

· ART24 or placebo

· Study-related medication and exams at no cost

· Compensation for reasonable travel and meal expenses

This study is currently recruiting in the following areas: Butte (MT), Riverton (UT), Shreveport (LA), Doral (FL), Hillsborough (NJ), Bronx (NY), New York (NY), Massapequa (NY/Long Island), Palm Springs (CA), and Boston (MA). 

To learn more or join the study please go to https://artugentherapeutics.com/

and click on More Information.

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

Acurx Pharmaceuticals

Acurx Pharmaceuticals is a publicly held, clinical stage biopharmaceutical company developing a new class of antibiotics for infections caused 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  Current treatments for C. difficile  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 replication of the DNA of the DNA of the bacterial cell.

Ibezapolstat is active against the GAIN Pathogen Clostridium difficile

C. difficile is a pathogen listed in the GAIN Act as a pathogen that causes serious or life-threatening infections and the CDC identifies a C. difficile infection as an urgent need in terms of generating new antibiotics to treat these infections.

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.

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.

December 2021 Press Release:   

Acurx Announces First Patient Enrolled in Phase 2b Clinical Trial of its Lead Antibiotic for Treatment of Clostridioides difficile Infection

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

 Crestone 

Is developing a novel antibiotic known as CRS3123 for treatment of C. difficile infection  In preclinical (early) studies CRS3123 has demonstrated that it quickly halts production of C. difficile toxin and spores via a new mechanism of action. In Phase 1 human clinical trials it caused minimal disruption of other, normal gut bacteria. In this Phase 2 study sponsored by NIAID (NIH), Crestone will test two different doses of CRS3123 compared to a standard antibiotic treatment for this infection called vancomycin.

If enrolled, subjects will receive either, 400 mg or 800 mg of CRS3123 or vancomycin for 10 days. Doses will be taken by mouth, every 6 hours. Neither subjects nor study healthcare providers will know which drug is being administered. Then subjects will be followed for an additional 60 days, resulting in about eight outpatient study visits over 70 days. Participants will receive study-related medication and exams at no cost and may be reimbursed for travel expenses for study visits.

The study will enroll subjects 18 or older who have a primary episode or first recurrence of C. difficile infections including diarrhea in the last 24 hours and a positive C. difficile toxin test on a stool sample. They may not participate if they have had more than one C. difficile infection  episode in the last three months (or one that was not initially responsive to vancomycin), or two C. difficile infection episodes in the past twelve months. Pregnant or breastfeeding women may not participate in this study, and other entry criteria apply. Study physicians will determine eligibility and then request subjects’ consent to participate.

This study is currently recruiting in the following areas: Sacramento, CA; Lancaster, CA; Calgary, AB CANADA; London, ON CANADA; St. Petersburg, FL; Miami Lakes, FL; Pompano Beach, FL; Miami, FL; Doral, FL; Idaho Falls, ID; Shreveport, LA; Rochester, MN; Omaha, NE; Mentor, OH; Toledo, OH; Uniontown, PA; Union City, TN; San Antonio, TX; Cedar Park, TX; Houston, TX; Seattle, WA.

To learn more, please visit Crestone’s website  https://www.crestonepharma.com/

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.

DEINOVE a French biotech company, pioneer in the exploration and exploitation of bacterial biodiversity to address the urgent, global challenge of antibiotic resistance, announced today that the independent Data Safety Monitoring Board (DSMB) has completed its review of the safety data from the first part of the Phase II clinical trial of DNV3837 in the treatment of Clostridioides difficile infection (CDI). The DSMB considered that the benefit/risk balance of antibiotic therapy with DNV3837 was in favor of continuing the recruitment in this trial.

The experience acquired during this first part of the study has made it possible to improve the trial protocol, with a reduction in dose by a factor of 4 and a reduction in the duration of administration by a factor of 2, reducing the intravenous treatment from 12 to 6 hours per day. This improvement simplifies the management of the trial for the investigating physicians and their teams.

The second part of the study will be conducted in an “open-label” manner, as DNV3837 is administered intravenously, while the standards of care are administered orally. Thus, all patients included in the trial (40 in total) will receive DNV3837.

To improve patients inclusion in the trial, it was decided to rapidly open new centers in addition to those active in the United States.

2022 Press Release:  

DEINOVE announces a favorable opinion from the DSMB for the continuation of the Phase II clinical trial of DNV3837 in Clostridioides difficile infections

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.

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 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) and is not approved by any regulatory body. It’s an investigational antibiotic being studied in adolescent patients with CDI. The purpose of the study is to determine whether ridinilazole is safe and effective as compared to the current standard of care. In an earlier clinical trial in patients with CDI, ridinilazole was found to have higher sustained clinical response compared to vancomycin. Sustained clinical response measured the if patients were cured after treatment and whether they experienced a recurrence within 30-days post-treatment. 

More information on ridinilazole can be found by visiting 

ww.summitplc.com/

Then click on Our Programs and C. difficile Infection.

Some key information about the trial:

· This trial is expected to enroll approximately 40 adolescent patients (12 to ≤ 18 years of age)

· Patients will be randomized to receive either ridinilazole or vancomycin, and neither the patients nor the study doctors will know which drug patients receive

· Participation will involve about 8 study visits and/or telephone contacts 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 have signs and symptoms of CDI, require CDI treatment, and have ≥ 3 unformed bowel movements in the 24 hours prior to study randomization

· Patients must have presence of free toxin A and/or B in stool

· 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

For further details regarding this clinical trial please visit https://clinicaltrials.gov/ct2/show/NCT04802837 or the study website at www.ricodifycdiff.com

Finch Therapeutics :

Finch Therapeutics is dedicated to harnessing the microbiome to transform lives. Finch is developing CP101, an orally administered microbiome product candidate, for the prevention of recurrent C. difficile (C. diff) infection. CP101 is designed to deliver a full community of beneficial bacteria to the areas of the intestine affected by C. diff.

CP101 for the prevention of recurrent C. diff is currently in late-stage clinical development and a Phase 3 clinical trial is planned. 

When additional information is available, an update will be shared on the Patient page of Finch’s website: https://www.finchtherapeutics.com/.

UPDATED 1/2022  

THIS IS A PARTIAL LIST OF CLINICAL TRIALS AND TO VIEW A COMPLETE LIST OF CLINICAL TRIALS CURRENTLY ENROLLING —  PLEASE VISIT  www.clinicaltrials.gov