Seres Therapeutics, Nestle Health Science gets FDA approval of VOWSTTM

The company states: "Seres Therapeutics announced the 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 in adults following antibacterial treatment for recurrent CDI. VOWST is not indicated for the treatment of CDI. Recurrent CDI represents significant unmet need and is a leading cause of hospital-acquired infection that can result in severe illness and death. Based on data from the U.S. Centers for Disease Control and Prevention, the companies estimate 156,000 episodes in the U.S. in 2023. The FDA approval of VOWST was supported by a robust Phase 3 development program that included the ECOSPOR III and ECOSPOR IV studies. VOWST was previously granted Breakthrough Therapy and Orphan Drug Designations by the FDA. ECOSPOR III was a multicenter, randomized, placebo-controlled study in individuals with rCDI, the results of which were published in the New England Journal of Medicine.2 The study’s primary objective was to demonstrate the reduction of CDI recurrence with VOWST. In ECOSPOR III, VOWST was shown to reduce CDI recurrence at eight weeks, with approximately 88% of individuals recurrence-free at eight weeks post-treatment, compared to 60% in participants who received placebo.2 In addition, at six months post-treatment, 79% of the VOWST group were demonstrated to be recurrence-free, compared to 53% in the placebo group.3 No treatment-related serious adverse events were observed in the active arm and the frequency of treatment-related adverse events was similar between the VOWST and placebo arms. The most common adverse reactions through eight weeks in VOWST treated participants versus placebo were solicited events of abdominal distention, fatigue, constipation, chills, and unsolicited event of diarrhea."