Seres Therapeutics Inc. is talking to FDA about using a different dose and a diagnostic that departs from the current standard of care in a new trial of its microbiome candidate SER-109 for recurrent Clostridium difficile infection, after conducting a detailed analysis of a failed mid-stage trial.
Seres Argues Different Diagnostic Needed In Recurrent C. Difficile Trials
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.
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