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Seres Therapeutics and Nestlé Health Science Present Results from ECOSPOR IV Phase 3 Study of VOWST™, a Microbiota-Based Oral Therapeutic for Prevention of Recurrence of C. Difficile Infection, at the Digestive Disease Week (DDW) Annual Meeting
– Data from Phase 3 open-label single-arm study of VOWST found nearly 95% of individuals with a clinical response at 8 weeks remained free of CDI through
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– Data from Phase 3 open-label single-arm study of VOWST found nearly 95% of individuals with a clinical response at 8 weeks remained free of CDI through Week 24, regardless of number of prior C. difficile infections (CDI) –\n\n\n– Results from ECOSPOR IV add to data from ECOSPOR III Phase 3 study and together supported the recent VOWST FDA approval –\n\n\n CAMBRIDGE, Mass. & HOBOKEN, N.J.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB), and Nestlé Health Science today announced the presentation of data from the Phase 3 open-label ECOSPOR IV study evaluating VOWST (fecal microbiota spores, live-brpk) – the first and only U.S. Food and Drug Administration (FDA)-approved orally administered microbiota-based therapeutic for the prevention of recurrence in adults with recurrent C. difficile (rCDI) following antibacterial treatment. VOWST is not indicated for the treatment of CDI. These data are shared as oral and poster presentations at the 2023 Digestive Disease Week® (DDW 2023) Annual Meeting being held in Chicago, Ill. on May 6-9.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230508005165/en/\n“In the ECOSPOR IV Phase 3 open-label single-arm study, high clinical response rates were achieved at week 8 and continued into week 24 following VOWST treatment, regardless of the number of prior CDI infections,” said Lisa von Moltke, M.D., Chief Medical Officer at Seres. “These results add to previous positive data from the randomized, placebo-controlled ECOSPOR III Phase 3 study. We are excited that VOWST is now approved by the FDA for the prevention of recurrent CDI following antibacterial treatment for rCDI, including in first recurrence patients.”\n\n\nOn April 26, VOWST was approved by the FDA for the prevention of recurrence of C. difficile infection in adults with rCDI following antibacterial treatment. The FDA approval of VOWST was supported by a robust Phase 3 development program that included the ECOSPOR III (NCT03183128) and ECOSPOR IV (NCT03183141) studies. VOWST was previously granted Breakthrough Therapy and Orphan Drug Designations by the FDA.\n\n\nThe data being presented at DDW include safety and efficacy data from the ECOSPOR IV study, an open-label extension study of ECOSPOR III and an open-label program evaluating VOWST in 263 adults with r...