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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"There's a lot of hope and hype still in the microbiome sphere," Ferring's president Per Falk tells Scrip, but the rewards could be considerable for companies that can deliver well-documented safety and efficacy data and do not take try to take shortcuts.
After a trial failure in 2016, four rival companies could produce pivotal data this year
As it talks study design with FDA, Seres says new analysis of Phase II trial of microbiome candidate SER-109 suggests that a C. difficile cytotoxin test would be more accurate and that a higher dose may be more effective.