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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Seres and rival Ferring are both hoping to have the first-ever FDA-approved microbiome therapeutic but the US firm has secured a strong commercial partner in Nestlé's Aimmune pharma arm to drive SER-109 over the finishing line.
The public biotech’s first foray into the microbiome started well, but a clinical trial failure followed by a success has now left Seres with both regulatory and commercial issues.
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.