C Diff Drug Development

A month after another setback in its plans to treat ulcerative colitis, Seres Therapeutics quietly disclosed it will not move forward with a Phase Ib trial. The move, disclosed in an SEC filing Wednesday, puts Seres in a predicament as the Cambridge, MA biotech failed with one potential UC drug,

Background Effective treatment options for recurrent Clostridioides difficile infection (rCDI) are limited, with high recurrence rates associated with the current standard of care. Herein we report results from an open-label Phase 2 trial to evaluate the safety, efficacy, and durability of RBX2660—a standardized microbiota-based investigational live biotherapeutic—and a closely-matched historical control cohort. Methods This prospective, multicenter, open-label Phase 2 study enrolled patients who had experienced either ≥ 2 recurrences of CDI, treated by standard-of-care antibiotic therapy, after a primary CDI episode, or ≥ 2 episodes of severe CDI requiring hospitalization. Participants received up to 2 doses of RBX2660 rectally administered with doses 7 days apart. Treatment success was defined as the absence of CDI diarrhea without the need for retreatment for 8 weeks after completing study treatment. A historical control group with matched inclusion and exclusion criteria was identified from a retrospective chart review of participants treated with standard-of-care antibiotics for recurrent CDI who matched key criteria for the study. The primary objective was to compare treatment success of RBX2660 to the historical control group. A key secondary outcome was the safety profile of RBX2660, including adverse events and CDI occurrence through 24 months after treatment. In addition, fecal samples from RBX2660-treated participants were sequenced to evaluate microbiome composition and functional changes from before to after treatment. Results In this Phase 2 open-label clinical trial, RBX2660 demonstrated a 78.9% (112/142) treatment success rate compared to a 30.7% (23/75) for the historical control group (p

Our findings do not suggest CI proteins CI_01448 and CI_01447, which cross-react with antibodies against CD toxins A and B, are toxic to HeLa cells. Further studies are needed to determine the function of these cross-reacting proteins and the potential virulence factors that could be responsible for …

Finch Therapeutics has joined the ranks of biotechs that are narrowing their focus. | Finch Therapeutics has joined the ranks of biotechs that are narrowing their focus. With its lead program under clinical hold, the microbiome specialist has pulled out of a planned study in chronic hepatitis B.

/PRNewswire/ -- Morningside Ventures today announced the launch of Adiso Therapeutics, a clinical-stage biotechnology company advancing a pipeline of novel...

While physicians express excitement surrounding products in the microbiome sector, current challenges with access to fecal microbiota transplants may translate into slow adoption EXTON, Pa., March 23, 2022 /PRNewswire/

DNV3837 Drug Trial update

RBX2660, a standardized, stabilized, novel microbiota-based live therapeutic, shows promise treating patients with recurrent Clostridium difficile infection.

A new report from an industry association showed an increase in development from small companies, but funds remain limited.

Nearly 8 in 10 patients with recurrent C. diff. Infection were successfully treated after up to 2 doses of the microbiota-based therapy.

A new report on the recurrent #Cdiff infection therapy RBX2660 from @ferring suggests the microbiome benefits of the therapy can last up to 2 years #IDtwitterhttps://t.co/ZrFCIBlyOF— Contagion (@Contagion_Live) March 22, 2022

Pfizer’s $6.7 billion bet on Arena Pharmaceuticals has delivered a phase 3

Seres Therapeutics, Inc. will present preclinical findings tomorrow at the European Bone Marrow Transplantation (EBMT) Annual Meeting.

Pfizer’s investigational C. diff vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. diff infection.

In this Phase 2 trial, RBX2660 was safe and effective for reducing rCDI recurrence as compared to a historical control group. Microbiome changes are consistent with restorative changes implicated in resisting C. difficile recurrence. Clinical Trials Registration NCT02589847 (10/28/2015).

Finch was still able to continue dosing patients in its past-ongoing PRISM-EXT phase 2 open-label trial of CP101 in recurrent CDI, because the CP101 lots used for PRISM-EXT were manufactured from material donated prior to December 1, 2019.

Finch Therapeutics said it is providing information to the Food and Drug Administration to explain its testing protocols.

The FDA has lifted the clinical hold on Selecta Bioscience’s gene therapy to treat methylmalonic acidemia, a rare disease in children that affects metabolism. | The FDA has lifted the clinical hold on Selecta Bioscience’s gene therapy to treat methylmalonic acidemia, a rare disease in children that affects metabolism. The company is now back in the saddle as it preps for a phase 1 trial.

There's mixed news from Pfizer on results from the CLOVER trial of their candidate vaccine for preventing C diff infection.

New York-based Pfizer Inc. announced results from the CLOVER pivotal Phase 3 study evaluating its Clostridioides difficile (C. difficile) vaccine candidate (PF-06425090) in the prevention of C. difficile infection (CDI). Initial analyses of two protocol-defined secondary endpoints indicated a highly favorable benefit in reducing CDI severity and 100% vaccine efficacy in preventing medically attended CDI. However, the trial did not meet its pre-specified primary endpoint of prevention of primary CDI.

Colonization of the gastrointestinal (GI) tract with pathogenic bacteria is an important risk factor for the development of certain potentially severe and life-threatening healthcare-associated infections, yet efforts to develop effective decolonization agents have been largely unsuccessful thus far …

The company’s investigational PF-06425090 vaccine did show benefits including decreased median infection period and no hospitalizations in the vaccinated cohort.

UB professor Charles Berenson was a co-author of the New England Journal of Medicine article that reported on the clinical trial.

People who develop colitis with the virulent bacterium C. difficile, usually after a course of antibiotics or chemotherapy, experience severe diarrhea, inflammation of the colon and abdominal pain. Each year, nearly half a million Americans suffer from it. About 1 in 6 will go on to experience a relapse, and sometimes it continues to recur. C. difficile infections (CDI) are responsible for approximately 20,000 deaths annually.

Patients with diarrhea did have longer hospital stays than patients without diarrhea.