With positive top-line Phase III data in hand, Seres Therapeutics, Inc. thinks it is positioned to file its microbiome-derived candidate for recurrent Clostridium difficile infections for approval, which could make it the first approved microbiome therapy. First, however, the biotech needs to convince the US Food and Drug Administration that it has an adequate data package to obtain approval based on a single pivotal study.
Seres Aims To File C. Diff Microbiome Drug On Single Pivotal Trial
Competing with several other firms to bring the first microbiome-derived therapy to market, Seres says the magnitude of its Phase III efficacy compared to placebo may enough for registrational filing.
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