Seres Sets Phase Ill Results of SER-109 for Recurrent C. Difficile

 In ECOSPOR lll, Seres’ lead therapeutic candidate incorporated itself rapidly and durably into the microbiome to prevent C. difficile infection recurrence –

– Within one week of treatment, SER-109 was observed to diversify the microbiome and support the production of fatty acids that inhibit the growth of C. difficile –

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome company, today announced the presentation of data from its Phase 3 ECOSPOR III study that suggest investigational microbiome-based therapeutic SER-109 prevents recurrent C. difficile infections (rCDI) by rapidly establishing a long-lasting colony of beneficial gut microbes, which can produce fatty acids that disrupt the C. difficile lifecycle. These data were shared in oral and poster presentations at the 2022 Digestive Disease Week (DDW) Annual Meeting.

“These results suggest that our investigational microbiome therapeutic, SER-109, is a potentially fast-acting intervention that can provide durable relief from recurrent C. difficile infections when administered to vulnerable patients,” said Matthew Henn, Ph.D., Chief Scientific Officer at Seres. “Confirming the multiple mechanisms that bacteria in SER-109 utilize to prevent this notoriously challenging infection on the cellular and molecular level not only increases our confidence in this particular therapeutic, but it has the potential to help guide the design of the next generation of microbiome-based therapeutics.”

Seres expects to finalize a Biologics License Application (BLA) submission for SER-109 with the U.S. Food and Drug Administration (FDA) in mid-2022, positioning SER-109 up to potentially become the first ever FDA-approved microbiome-based therapeutic for treating recurrent C. difficile infections with a potential product launch in the first half of 2023.

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