Business
Seres Therapeutics and Nestlé Health Science Announce FDA Approval of VOWSTTM (fecal microbiota spores, live-brpk) for Prevention of Recurrence of C. difficile Infection in Adults Following Antibacterial Treatment for Recurrent CDI
– First and only FDA-approved orally administered microbiota-based therapeutic, validating Seres’ microbiome platform – – Phase 3 ECOSPOR III study
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– First and only FDA-approved orally administered microbiota-based therapeutic, validating Seres’ microbiome platform –\n\n\n– Phase 3 ECOSPOR III study demonstrated that 88% of treated individuals were recurrence-free at 8 weeks –\n\n\n– Opportunity to address prevention of recurrence of C. difficile infection in adults with rCDI, including first recurrence, following antibacterial treatment –\n\n\n– VOWST product availability expected in June –\n\n\n– Conference call at 8:30 a.m. ET tomorrow –\n\n\n CAMBRIDGE, Mass. & HOBOKEN, N.J.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science today announced the U.S. Food and Drug Administration (FDA) approval of VOWSTTM (fecal microbiota spores, live-brpk), formerly called SER-109, an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST is not indicated for the treatment of CDI.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230426006066/en/(Graphic: Business Wire)\n“Since being founded by Flagship Pioneering over a decade ago, Seres has led the development of microbiome therapeutics, and today’s FDA approval of VOWST as the first orally administered microbiota-based therapeutic for the prevention of recurrent C. difficile infection marks a tremendous milestone for the patient community, and for Seres. We are deeply grateful to the patients, caregivers, clinical investigators, and employees who contributed to the discovery, development, and approval of VOWST,” said Eric Shaff, President and Chief Executive Officer at Seres. “With VOWST, we and Nestlé Health Science have the opportunity to prevent recurrence in a broad group of adult rCDI patients, including those who have experienced a first recurrence.”\n\n\n“Our strategic collaboration with Seres is part of Nestlé Health Science’s ongoing commitment to advancements in the gastrointestinal space to address unmet patient needs,” said Greg Behar, Chief Executive Officer, Nestlé Health Science. “Our teams have vast experience in gastrointestinal disorders and are poised to engage with healthcare professionals to start addressing this critical need for patients. We expect VOWST to be available in June and look forwa...