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First microbiome-based drug clears phase III, in clinical trial turnaround
Seres Therapeutics’ stool-derived treatment for recurrent Clostridium difficile infection could become the first FDA-approved microbiome therapy. Several other live biotherapeutic microbial products are close behind.
The field of microbiome therapeutics received a big boost in August, when Seres Therapeutics’ gut microbiota capsule SER-109 met its primary end point in a phase III trial in recurrent Clostridium difficile infection (CDI). Just 4 years ago, the field saw investment dry up after the same drug failed in a much-watched phase II trial. SER-109 is now back on track for what could become a first FDA approval for a microbiome-based drug.