Recurrent CDI Therapy RBX2660 Shows Durable Efficacy in Phase 2 Results
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 #IDtwitter
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 $7B bet delivers phase 3 success, advancing bid to establish new drug in ulcerative colitis Arena - FierceBiotech
Pfizer’s $6.7 billion bet on Arena Pharmaceuticals has delivered a phase 3
Unlocking the power of AI-driven pathology in drug development: An Interview with Bristol Myers Squibb - FierceBiotech
Correction for Oka et al., "In Vitro and In Vivo Antibacterial Activities of a Novel Quinolone Compound, OPS-2071, against Clostridioides difficile"
Seres Therapeutics Presents Preclinical Research on Investigational Microbiome Therapeutic SER-155 at the 2022 European Bone Marrow Transplantation Annual Meeting - BioSpace
Seres Therapeutics, Inc. will present preclinical findings tomorrow at the European Bone Marrow Transplantation (EBMT) Annual Meeting.
Clostridioides difficile vaccine shows promise in Phase III trial - European Pharmaceutical Review
Pfizer’s investigational C. diff vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. diff infection.
Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial
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).
Adiso 'sprints out of the gate' with inflammatory disease focused pipeline that includes LBPs - BioPharma-Reporter.com
Phase 3 Trial Paused for CP101 in Recurrent C. difficle Infection - Pharmacy Times
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.
CDI Trial on Hold as FDA Probes SARS-CoV-2 Safety Protocols - Contagionlive.com
Finch Therapeutics said it is providing information to the Food and Drug Administration to explain its testing protocols.
Selecta back in phase 1 gene therapy saddle after clinical hold lift, plans to reboot 'expeditiously' | Fierce Biotech
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.
UB scientist co-authors NEJM paper showing how an oral microbiome therapy prevents recurrent C. difficile infections - ubmd.com
C difficile Vaccine: CLOVER Trial Shows Mixed Results - Medscape
There's mixed news from Pfizer on results from the CLOVER trial of their candidate vaccine for preventing C diff infection.
Clostridioides Difficile Vaccine Candidate Indicates Strong Potential Effect - Precision Vaccinations
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.
Development of 1,2,4-Oxadiazole Antimicrobial Agents to Treat Enteric Pathogens within the Gastrointestinal Tract
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 …
Pfizer's C Difficile Vaccine Did Not Meet Endpoint for Phase 3 Study - Contagionlive.com
The company’s investigational PF-06425090 vaccine did show benefits including decreased median infection period and no hospitalizations in the vaccinated cohort.
Therapy for preventing recurrent C. difficile infections
UB professor Charles Berenson was a co-author of the New England Journal of Medicine article that reported on the clinical trial.
UB scientist co-authors NEJM paper demonstrating how an oral microbiome therapy prevents recurrent C. difficile infections
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.
No Connection Between C Difficile Colonization and Diarrhea, Length of ICU Stay
Patients with diarrhea did have longer hospital stays than patients without diarrhea.
Seres therapeutics is playing a long game
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).
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
Microbiome-Based Enema Effective for Recurrent C. difficile
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.
Rachel - Peggy Lillis Foundation
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 …
Pfizer joins Sanofi on the C. difficile failure train after its vaccine flopped a PhIII study
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
In an area where big pharma has failed to find success, US pharma giant Pfizer has joined the ranks,…
Mixed results for Phase III trial of Pfizer’s investigational Clostridioides difficile vaccine
Pfizer's seeks silver lining in failed C. diff vaccine trial
Pfizer’s vaccine for Clostridium difficile (C. diff) looks like it may join a growing list of candidates that
Vaccine failure blows a hole in Pfizer's pipeline
FDA slaps hold on Finch's microbiome C. difficile treatment, as biotech blames Covid-19 and old manufacturer
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
Finch Therapeutics Reports Enrollment Was Paused In Its PRISM4 Phase 3 Trial For Recurrent C. Difficile Infection Candidate - Benzinga
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