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Seres Pivotal Success And BLA Filing A Boost To Microbiome Modulator Field

 
• By Ayisha Sharma

The US firm has started a rolling US BLA for its infectious disease candidate, SER-109, following positive data from a second late-stage study, a milestone which could draw attention to firms in the microbiome space.   

The Microbiome Refers To Microorganisms That Live In Or On The Human Body • Source: Shutterstock

Seres Therapeutics, Inc. has started a rolling biologics license application with the US FDA for SER-109 in recurrent Clostridium difficile infection (CDI) with a mid-year completion date in what could be a tipping point for microbiome therapeutics.

Following the success of the pivotal ECOSPOR III trial, the US Food and Drug Administration had asked the firm to submit SER-109 safety data from at least 300 subjects which led to the open-label ECOSPOR IV study

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