Seres Therapeutics, Inc. and Nestlé Health Science announced the presentation of a post-hoc analysis from the Phase 3 development program for VOWST™, the first and only U.S. Food and Drug Administration (FDA)-approved orally administered microbiota-based therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). The analysis was featured as a late-breaker Emerging Science presentation at American Society of Microbiology (ASM) Microbe 2023 being held in Houston, TX (June 15-19).
“Results from this post-hoc analysis of the ECOSPOR III and ECOSPOR IV Phase 3 studies show that whether recurrent C. difficile infection patients have experienced either a first recurrence or multiple recurrences, patients exhibit a similar level of loss of microbiome diversity”
The presentation highlighted post-hoc gastrointestinal microbiome analyses of recurrent C. diff patients enrolled in the ECOSPOR III and ECOSPOR IV Phase 3 studies, including those with a first recurrence and multiple recurrences. Results showed that at baseline (pre-treatment), individuals experiencing a first recurrence or multiple recurrences exhibited a similarly low degree of gut microbiome diversity. Following treatment with VOWST, both first recurrence and multiple recurrence patient groups had a significant increase in microbiome diversity as well as increased levels of secondary bile acids, a metabolites shown to inhibit growth of C. difficile bacteria.
“Results from this post-hoc analysis of the ECOSPOR III and ECOSPOR IV Phase 3 studies show that whether recurrent C. difficile infection patients have experienced either a first recurrence or multiple recurrences, patients exhibit a similar level of loss of microbiome diversity,” said Lisa von Moltke, M.D., Chief Medical Officer at Seres. “Following treatment with VOWST, we observed an early robust increase in microbiome diversity in both patient groups within one week.”
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 (CDC), the companies estimate 156,000 episodes in the U.S. in 2023.
SOURCE: Businesswire