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Abstracts

Microbiome and Bile Acid Restoration was Consistent Across Three Clinical Trials of Rbx2660 for Recurrent Clostridioides Difficile Infection: A Combined Analysis

Ken Blount PhD1, Heidi Hau PhD1, Romeo Papazyan PhD2, Bryan Fuchs PhD2, Bill Shannon PhD MBA3, Carlos Gonzalez MS31Rebiotix Inc, Roseville, MN, USA, A Ferring Company; 2Ferring Research Institute, San Diego, CA, USA 3BioRankings, LLC, St. Louis, MO, USA Background Recurrent Clostridioides difficile infections (rCDI) are an urgent public health threat associated with microbiota disruption. […]

RBX2660, an Investigational Live Microbiota-based Biotherapeutic, Improves Outcomes of Clostridioides difficile Infection in a Real-World Population: A Retrospective Study of Use Under Enforcement Discretion

Paul Feuerstadt1, Adam Harvey2, Lindy Bancke21Gastroenterology Center of Connecticut, Hamden, CT; 2Rebiotix Inc, a Ferring Company, Roseville, MN Background Recurrent Clostridioides difficile infection (rCDI) is an urgent public health threat. RBX2660 is a standardized, stabilized, investigational microbiota-based live biotherapeutic that has been evaluated in 5 prospective clinical trials. Eligibility criteria in clinical trials are often […]

Efficacy of Investigational Microbiota-Based Live Biotherapeutic RBX2660 in Individuals with Recurrent Clostridioides difficile Infection: Data from Five Prospective Clinical Studies

Lindy Bancke PharmD1, Xin Su MD11Rebiotix, Inc., a Ferring Company, Roseville, MN, USA Background Microbiota-based treatments have shown promise to reduce recurrence, morbidity, and mortality for recurrent Clostridioides difficile infections (rCDI), but consistent and reliable clinical efficacy data are needed to support regulatory approvals that broaden patient access.  Here we provide cumulative data from 5 […]

Treatment Success in Reducing Recurrent Clostridioides difficile Infection with Investigational Live Biotherapeutic RBX2660 is Associated with Microbiota Restoration: Consistent Evidence from a Phase 3 Clinical Trial

Ken Blount1, Dana Walsh1, Carlos Gonzalez2, Bill Shannon21Rebiotix, Inc., a Ferring Company, Roseville, MN, USA; 2BioRankings LLC St. Louis, MO, USA Background Several investigational microbiota-based live biotherapeutics are in clinical development for reducing recurrence of Clostridioides difficile infection (rCDI), including RBX2660 a liquid suspension of a broad consortium of microbiota, which includes Bacteridetes and Firmicutes. […]

Safety of Investigational Microbiota-Based Live Biotherapeutic RBX2660 in Individuals with Recurrent Clostridioides difficile Infection: Data From Five Prospective Clinical Studies

Tricia Braun PharmD, Beth Guthmueller, Adam Harvey PhD1Rebiotix, Inc. Roseville, MN, USA; 2BioRankings LLC St. Louis, MO, USA Background Microbiota-based treatments have shown promise to reduce recurrence, morbidity, and mortality for recurrent Clostridioides difficile infections (rCDI), but consistent and reliable safety data are needed to support regulatory approvals and broaden patient access. Here we provide […]

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