C Diff Drug Development

LAS VEGAS — CP101, an investigational microbiome therapeutic, restored microbiome diversity and prompted a sustained clinical cure among patients with recurrent Clostridioides difficile infection, according to a presentation. “Recurrent C. difficile infection is common following standard of care antibiotics and remains a significant burden on the health care system. Treatment

EnteroBiotix, a Scottish biopharma focused on making gut microbiome therapies, said construction of its new manufacturing, lab and office facility has been completed.

A new study presented at ACG 2021 shows microbiome therapeutic CP101 effective in preventing recurrent CDI by increasing intestinal microbiome diversity.

Approximately 88% of patients treated with SER-109 achieved a sustained clinical response at 8 weeks.

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Freeze-dried human stool may offer advantages for the treatment of C difficile infections.

New data from PRISM3 Phase 2 trial show CP101 demonstrated statistically significant efficacy for prevention of recurrent C. difficile infection and a favorable safety profile through 24 weeks Additional PRISM3 microbiome data show CP101 engraftment leads to an increase in intestinal microbiome

Clostridioides difficile is an antibiotic-resistant bacterium that causes serious, toxin-mediated enteric disease in humans and animals. Gut dysbiosis and resultant alterations in the intestinal bile acid profile play an important role in the pathogenesis of C. difficile infection (CDI). Restoration of the gut microbiota and re-establishment of bacterial bile acid metabolism using fecal microbiota transplantation (FMT) has been established as a promising strategy against this disease, although this method has several limitations. Thus, a more defined and precise microbiota-based approach using bacteria that biotransform primary bile acids into secondary bile acids could effectively overcome these limitations and control CDI. Therefore, a screening pipeline was developed to isolate bile acid converting bacteria from fecal samples. Dogs were selected as a model CDI-resistant microbiota donor for this pipeline, which yielded a novel Peptacetobacter hiranonis strain that possesses unique anti- C. difficile properties, and both bile acid deconjugation and 7-α dehydroxylating activities to perform bile acid conversion. The screening pipeline included a set of in vitro tests along with a precision in vivo gut colonization and bile acid conversion test using altered Schadler flora (ASF) colonized mice. In addition, this pipeline also provided essential information on the growth requirements for screening and cultivating the candidate bacterium, its survival in a CDI predisposing environment, and potential pathogenicity. The model pipeline documented here yielded multiple bile acid converting bacteria, including a P. hiranonis isolate with unique anti- C. difficile biotherapeutic potential, which can be further tested in subsequent preclinical and human clinical trials. ### Competing Interest Statement The authors have declared no competing interest.

A University of California, Irvine-led study suggests that the glucosyltransferase domain (GTD) is an ideal molecular target for therapeutic interventions for Clostridioides difficile infection (CDI). These findings may lead to new treatments to fight this deadly disease.

Current clinical trials and research studies in digestive health

CAMBRIDGE, Mass., October 02, 2021--Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced late-breaking data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapeutic for recurrent C. difficile infection (rCDI). SER-109 was associated with significantly greater reduction of antimicrobial resistance genes (ARGs) compared to placebo, with the reduction observed both rapidly (by Week 1) and sustained through W

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.

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 »

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

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 »

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 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 Biosciences, VE303, C. difficile infection, Phase II, BARDA, PureTech Health

/PRNewswire/ -- Lumen Bioscience—a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases—today announced new...

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.

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

Researchers conducted a study to determine whether the investigational oral microbiome therapeutic SER-109 decreases the risk for recurrent Clostridioides difficile infection.

New research presented at IDWeek 2021 presented data on the microbiota-based live biotherapeutic RBX2660 for recurrent Clostridioides difficile infection.

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