The US FDA has approved VOWST (formerly called SER-109), an orally administered microbiota-based therapeutic which is expected to be available in June
The approval was based on the results from the P-III (ECOSPOR III & IV) published in the NEJM & the JAMA Network Open evaluating VOWST vs PBO in 182 & 263 adult patients. The (ECOSPOR III) trial showed a reduction in CDI recurrence @8wks., (~88% vs 60%) were recurrence-free @8wks.; 79% vs 53% at 6mos. post-treatment, no treatment-related SAEs were seen & the frequency of TRAEs was similar b/w treatment arms
The (ECOSPOR IV) study results contributed to the VOWST safety database & supported product approval. Seres & Nestlé Health Science collaborated in July 2021 to jointly commercialize VOWST in the US & Canada
Ref: Seres Therapeutics | Image: Seres Therapeutics
Related News:- Seres Therapeutics Reports P-III Trial (ECOSPOR IV) Results of SER-109 for the Prevention of Recurrent C. Difficile Infection
