C Diff Drug Development

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.

Disappointing: phase 3 trial of Pfizer's #Cdiff vaccine failed to meet its primary endpoint, with efficacy of 31% against first primary episode of #CDI (after 3 doses). https://t.co/wUK60eZmsZ— Tom Sandora (@tomsandora) March 2, 2022

A stool-based enema composed of a broad variety of microbes (RBX2660, Rebiotix/Ferring) was up to 84% effective in reducing recurrent emClostridioides difficile/em infection (rCDI) in a study of more than 720 adults with rCDI.

I got sick the day after Christmas 2021. I had fever, chills, lower right quadrant pain, and I was going to the bathroom 6 times a day. I had just finished Augmentin for a sinus infection. I went to the ER and they did CT scan and blood work. I …

Big Pharma has been trying to come up with a vaccine for C. difficile infection for years, but one more program joined the heap of recent failures. Pfizer reported that a Phase III study of its experimental shot did not meet its primary endpoint for preventing the infection, the company

Mixed results for Phase III trial of Pfizer’s investigational Clostridioides difficile vaccine

Pfizer’s vaccine for Clostridium difficile (C. diff) looks like it may join a growing list of candidates that

Drugmakers working on treatments for C. difficile infections are having a bad week. Just one day after Pfizer reported its C. difficile vaccine candidate did not hit the primary endpoint in a Phase III study, Finch Therapeutics is finding itself in a similar position. The biotech said Tuesday its microbiome

This headline-only article is meant to show you why a stock is moving, the most difficult aspect of stock trading. Every day we publish hundreds of headlines on any catalyst that...

Pfizer Inc (NYSE: PFE) announced data from the CLOVER Phase 3 trial evaluating Clostridioides difficile vaccine candidate to prevent C. difficile infection (CDI). Initial...

When firms reach FDA approval then go under, "the problem must be the market."

Pre-specified secondary endpoint showed 0-11 vaccine to placebo case split for medically attended C. difficile infection (CDI), corresponding to 100% vaccine efficacy Median CDI duration was 1 versus 4 days and mean duration was 3 versus 16 days comparing vaccine to placebo, corresponding to a 75% and 80% reduction in disease episode, respectively, in vaccinated people Vaccine was very well tolerated and showed a favorable safety profile Trial did not meet its pre-specified primary endpoint of prevention of primary CDI, however, for all CDI cases recorded at 14 days post dose 3, vaccine efficacy was 49%, 47% and 31% up to 12 months, 24 months and at final analysis, respectively Company evaluating next steps for C. difficile vaccine program in coordination with regulatory agencies Pfizer Inc. (NYSE:PFE) today announced results from the CLOVER trial ( CLO stridium difficile V accine E fficacy T R ial), a pivotal Phase 3 study evaluating its Clostridioides difficile ( C. difficile )

(HealthDay)—An investigational microbiome therapeutic composed of purified Firmicutes spores, SER-109, is superior to placebo for treatment of recurrent Clostridioides difficile infection, according ...

SOMERVILLE, Mass., Feb. 23, 2022 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop

Join us to tackle one of the most important challenges of our time: antimicrobial resistance (AMR)! The Castagner Lab is developing non-antibiotic approaches against the Clostridioides difficile pa…

Nature Medicine - Multi-modal profiling reveals major alterations in colonic B cells in patients with ulcerative colitis, including reduced clonal diversity of plasma cells, and suggests that...

A stool-based enema composed of a broad variety of microbes (RBX2660, Rebiotix/Ferring) was up to 84% effective in reducing recurrent emClostridioides difficile/em infection in a study of more than 720 adults with rCDI. br /p /p