C Diff Drug Development

Clostridioides difficile infection (CDI) is the major identifiable cause of antibiotic-associated diarrhea. The emergence of hypervirulent C. difficile strains has led to increases in both hospital- and community-acquired CDI. Furthermore, CDI relapse from hypervirulent strains can rea …

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Many antibiotics prescribed in the United States are unnecessary or inappropriate. Improved antibiotic stewardship is needed, not only to curb the threat of antibiotic resistance but also to avoid exposing patients to unnecessary risks.

C. difficile is one of the leading causes of hospital-acquired infections. Arrieta-Ortiz et al. report three predictive models (with extensive validations) for dissecting interplay of regulation and metabolism that underlies host-pathogen interactions of C. difficile. The C. difficile interactive web portal provides access to these models, compiled datasets, and algorithms.

Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), today announced positive topline results from PRISM-EXT, an open-label extension of the company’s PRISM3 Phase 2 placebo-controlled trial evaluating CP101 for the prevention of recurrent C. difficile infection (CDI).

BASEL, Switzerland & CAMBRIDGE, Mass. & HORSHOLM, Denmark, November 10, 2021--Bacthera, a specialized contract development and manufacturing organization (CDMO), and Seres Therapeutics, a leading microbiome therapeutics company, announced today a collaboration to manufacture SER-109, Seres’ lead product candidate for recurrent Clostridioides difficile infection (rCDI). Under the terms of the agreement, Bacthera is establishing a dedicated facility for commercial manufacturing in its new Microbio

Finch Therapeutics Group Inc (NASDAQ: FNCH) announced positive topline results from PRISM-EXT, an open-label extension of the PRISM3 Phase 2 trial evaluating CP101...

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 new microbiome data from its Phase 2a clinical trial for C. difficile Infection (CDI) were presented at the 9th International C. diff Conference & Health Expo entitled: "Can Emerging Microbiome Findings Contribute to CDI Anti-Recurrence Effect?" The presentation was made on Novembe

Ferring Pharmaceuticals today announced positive results across all five of its prospective trials for a live biotherapeutic designed to reduce recurrent C. difficile infection (rCDI).

Researchers evaluated the safety and efficacy of the investigational, microbiota-based, live biotherapeutic RBX2660 for treatment of recurrent C difficile infection.

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). ...

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 new microbiome data from its Phase 2a clinical trial for C. difficile Infection (CDI) will be presented at the 9th Annual International C. diff Conference & Health Expo. taking place virtually on November 4-5, 2021.

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 »