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 Banks Serious Cash To Drive Microbiome Therapy To Market
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.
Stockwatch: The Fall, Rise And Challenges Of Seres' Microbiome Therapy
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.
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.