Clinical Development Program Shows Promise for Microbiome-Based Therapeutics in Recurrent C. Diff - Pharmacy Times
Lindy Bancke, PharmD, head of clinical development at Rebiotix Inc, said the clinical development program of RBX2660 is showing promise in the treatment of recurrent C. Difficile infection.
BARDA to support Phase 3 trial of treatment for C. difficile bacterial infections
VE303, an oral treatment developed by Vedanta Biosciences for patients at high risk of recurrent C. difficile infections (CDI), will get a Phase 3 clinical evaluation trial, thanks to support from the Biomedical Advanced Research and Development Authority (BARDA). Support … Read More »
Lumen lands another DoD contract to treat Covid-related GI issues - Endpoints News
The team at Lumen Bioscience believes that it can help patients, including those infected with Covid-19, through its plant-based drug LMN-301. Wednesday, it announced that the US Army is a believer too, handing the company development funding for its monoclonal antibody cocktail. This deal builds on a previous grant from
BARDA to support Phase 3 trial of treatment for C. difficile bacterial infections - Homeland Preparedness News
VE303, an oral treatment developed by Vedanta Biosciences for patients at high risk of recurrent C. difficile infections (CDI), will get a Phase 3 clinical evaluation trial, thanks to support from the Biomedical Advanced Research and Development Authority (BARDA). Support … Read More »
Ferring Presents Complete Data across Five RBX2660 Trials Demonstrating Consistent and Durable Efficacy in Recurrent C. Difficile Infection, as Well as Multiple Analyses Demonstrating Positive Shifts in Microbiome Properties
Shoe Swabs Find High C. diff Counts Outside Healthcare Sites
Clostridioides difficile, or C. diff, is most often thought of as a disease acquired in healthcare facilities, but researchers find that shoe bottoms tell another story of transmission in communities.
Vedanta Phase II Data Position It To Chase Seres In C. Difficile Recurrence
Vedanta thinks its live biotherapeutic sourced from clonal cell banking could offer strong prevention against C. difficile infections after antibiotics have cleared an initial infection.
Vedanta Bio guts out microbiome trial win to keep up with field, get BARDA cash
Vedanta Biosciences is developing its microbiome therapy with support from the Biomedical Advanced Research and Development Authority. Under terms of that contract, the positive Phase 2 results in preventing recurrent C. diff infection trigger a $23.8 million payment.
RT @SeresTX: We’ve just announced late-breaking data from our Phase 3 ECOSPOR III study evaluating SER-109 in patients with recurrent #Cdif…
We’ve just announced late-breaking data from our Phase 3 ECOSPOR III study evaluating SER-109 in patients with recurrent #Cdiff infection. https://t.co/CTljTHDX52 #IDWeek2021 pic.twitter.com/GlOmLCmSkc— Seres Therapeutics (@SeresTX) October 2, 2021
Recurrent C difficile Infection Risk in Patients Treated With the Investigational Oral Microbiome Therapeutic SER-109
Researchers conducted a study to determine whether the investigational oral microbiome therapeutic SER-109 decreases the risk for recurrent Clostridioides difficile infection.
Research Highlights Effect of New Biotherapeutic on Clostridioides difficile Infection - AJMC.com Managed Markets Network
New research presented at IDWeek 2021 presented data on the microbiota-based live biotherapeutic RBX2660 for recurrent Clostridioides difficile infection.
Seres Therapeutics Presents Data Supporting its Microbiome Pipeline at IDWeek 2021, Including Data from SER-109 Phase 3 ECOSPOR III Study in Recurrent C. Difficile Infection - Yahoo Finance
CAMBRIDGE, Mass., September 29, 2021--Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapy for recurrent C. difficile infection (rCDI), will be presented at the IDWeek 2021 Virtual Conference (Sept. 29-Oct. 3). The Company will be presenting seven posters and oral presentations related to SER-109 and C. difficile, including a late-breaker, as well
Recurrent C difficile Infection Risk in Patients Treated With the Investigational Oral Microbiome Theraputic SER-109 - Infectious Disease Advisor
Researchers conducted a study to determine whether the investigational oral microbiome therapeutic SER-109 decreases the risk for recurrent Clostridioides difficile infection.
Acurx Announces New Microbiome Data from Its Phase 2a Clinical Trial of Ibezapolstat for CDI in a Scientific Poster Presentation at IDWeek 2021 Conference - Yahoo Finance
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that a scientific abstract and poster presentation will be given at the Infectious Disease Society of America (IDSA) IDWeekTM 2021, taking place virtually from September 29 – October 3, 2021:
Ferring Presents Complete Data across Five RBX2660 Trials Demonstrating Consistent and Durable Efficacy in Recurrent C. Difficile Infection, as Well as Multiple Analyses Demonstrating Positive Shifts in Microbiome Properties
Data from award-winning presentation at IDWeek 2021 represents the first time Ferring is showcasing the RBX2660 clinical development program as a whole,…
Data from Trials Demonstrates Therapy Reduces Recurrent C Diff
Ferring is presenting data from five studies at this week’s IDWeek about its investigational biotherapeutic, RBX2660, being studied for this problematic bacterium.
Summit Therapeutics Presents Further Breakthrough Insights Surrounding the Novel Mechanism of Action for its Investigational Drug Ridinilazole During IDWeek 2021
Cambridge, Massachusetts, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit” or the “Company”) is today displaying an important ePoster at IDWeek 2021. IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Summit’s ePoster provide
RBX7455, a Non-frozen, Orally Administered Investigational Live Biotherapeutic, Is Safe, Effective, and Shifts Patients’ Microbiomes in a Phase 1 Study for Recurrent Clostridioides difficile Infections | Clinical Infectious Diseases | Oxford Academic
In this open-label phase 1 study, 3 RBX7455 oral dosing regimens were safe and demonstrated an average of 90% efficacy at preventing recurrent Clostridioides di
S100B Inhibition Attenuates Intestinal Damage and Diarrhea Severity During Clostridioides difficile Infection by Modulating Inflammatory Response
The involvement of the enteric nervous system, which is a source of S100B, in Clostridioides difficile (C. difficile) infection (CDI) is poorly understood although intestinal motility dysfunctions are known to occur following infection. Here, we investigated the role of S100B in CDI an …
Acurx Announces New Microbiome Data from Its Phase 2a Clinical Trial of Ibezapolstat for CDI in a Scientific Poster Presentation at IDWeek 2021 Conference - PRNewswire
/PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of...
Next-generation prebiotic promotes selective growth of bifidobacteria, suppressing Clostridioides difficile
Certain existing prebiotics meant to facilitate the growth of beneficial bacteria in the intestine also promote the growth of other prominent bacteria. Therefore, the growth-promoting effects of β-galactosides on intestinal bacteria were analyzed. Galactosyl-β1,4-l-rhamnose (Gal-β1,4-Rha) selectivel …
Impact of investigational microbiota therapeutic RBX2660 on the gut microbiome and resistome revealed by a placebo-controlled clinical trial | Microbiome | Full Text
Background Intestinal microbiota restoration can be achieved by complementing a subject’s perturbed microbiota with that of a healthy donor. Recurrent Clostridioides difficile infection (rCDI) is one key application of such treatment. Another emerging application of interest is reducing antibiotic-resistant genes (ARGs) and organisms (AROs). In this study, we investigated fecal specimens from a multicenter, randomized, double-blind, placebo-controlled phase 2b study of microbiota-based investigational drug RBX2660. Patients were administered either placebo, 1 dose of RBX2660 and 1 placebo, or 2 doses of RBX2660 via enema and longitudinally tracked for changes in their microbiome and antibiotic resistome. Results All patients exhibited significant recovery of gut microbiome diversity and a decrease of ARG relative abundance during the first 7 days post-treatment. However, the microbiome and resistome shifts toward average configurations from unperturbed individuals were more significant and longer-lasting in RBX2660 recipients compared to placebo. We quantified microbiome and resistome modification by RBX2660 using a novel “transplantation index” metric. We identified taxonomic and metabolic features distinguishing the baseline microbiome of non-transplanted patients and taxa specifically enriched during the process of transplantation. We elucidated the correlation between resistome and taxonomic transplantations and post-treatment dynamics of patient-specific and RBX2660-specific ARGs. Whole genome sequencing of AROs cultured from RBX2660 product and patient samples indicate ARO eradication in patients via RBX2660 administration, but also, to a lesser extent, introduction of RBX2660-derived AROs. Conclusions Through shotgun metagenomic sequencing, we elucidated the effects of RBX2660 in the microbiome and resistome. Antibiotic discontinuation alone resulted in significant recovery of gut microbial diversity and reduced ARG relative abundance, but RBX2660 administration more rapidly and completely changed the composition of patients’ microbiome, resistome, and ARO colonization by transplanting RBX2660 microbiota into the recipients. Although ARGs and AROs were transmitted through RBX2660, the resistome post-RBX2660 more closely resembled that of the administered product—a proxy for the donor—than an antibiotic perturbed state. Trial registration ClinicalTrials.gov, NCT02299570 . Registered 19 November 2014 Video Abstract
The @US_FDA has granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation to Crestone's CRS3123 for the treatment of CDI. Learn more: https://t.co/IkoQ7GpMGr #Cdiff
RBX2660 for Recurrent Clostridium difficile Infection | Rebiotix Inc.
Clinical trial information for RBX2660 for the treatment of recurrent Clostridium difficile infection. Includes information on PUNCH CD, PUNCH CD2, PUNCH Open Label, PUNCH CD3 and PUNCH CD3-OLS.
