Stockwatch: The Fall, Rise And Challenges Of Seres' Microbiome Therapy
A Stunning Reversal Of Fortune Still Poses Crucial Challenges For Seres
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.
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The promise of microbiome-based therapeutics to treat a variety of diseases has become a hot topic and the first to get to market will be targeting Clostridioides difficile infection. Ferring and its subsidiary Rebiotix are in pole position.
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.
It takes a lot of negotiation with regulators, advisory boards, and alignment between commercial and portfolio management teams to define and agree a clinical trial protocol. Why on earth would companies change it once a study is underway?