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Seres Aims To File C. Diff Microbiome Drug On Single Pivotal Trial

 
• By Joseph Haas

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.

Clostridium difficile bacteria, 3D illustration. Spore-forming bacteria that cause pseudomembraneous colitis and are associated with nosocomial antibiotic resistance
Seres hopes to improve the standard of care in recurrent C. diff with a microbiome therapy

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.

The Cambridge, MA-based company reported on 10 August that in top-line data from the 182-patient ECOSPOR III study, SER-109 yielded...

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