Business
Seres Therapeutics Achieves Enrollment of 300 Subjects with Phase 3 ECOSPOR IV Open-Label Extension Study of SER-109, a Potentially First-in-Class Investigational Microbiome Therapeutic for Recurrent C. difficile Infection
– Seres expects both the completed Phase 3 study results and the pending open-label study database to finalize a Biologics License Application (BLA) filing
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– Seres expects both the completed Phase 3 study results and the pending open-label study database to finalize a Biologics License Application (BLA) filing in mid-2022 –\n\n– Potential to be first-ever FDA-approved microbiome therapy –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced it has achieved enrollment of 300 subjects with the ECOSPOR IV open-label study evaluating SER-109, an investigational oral microbiome therapeutic for recurrent C. difficile infection (rCDI). The target enrollment of a minimum of 300 subjects for the SER-109 safety database was reached in conjunction with a prior completed Phase 3 study, ECOSPOR lll. Seres is required by the U.S. Food and Drug Administration (FDA) to demonstrate safety of SER-109 in at least 300 subjects who have received the dose to be commercialized, consistent with standard FDA guidance, with a 24-week follow-up period, to support a Biologics License Application (BLA) submission. Seres plans to close enrollment in the open-label study in the coming weeks and will engage with the FDA on initiation of an expanded access program by the end of the year. Seres intends to seek agreement with the FDA to begin a rolling submission of the BLA for SER-109 in the first half of 2022 and finalize the submission with data from the safety database in mid-2022.\n\n“This is a meaningful milestone for the company as it positions us for a BLA submission that, if approved, could make SER-109 the first-ever FDA-approved microbiome therapeutic,” said Eric Shaff, Chief Executive Officer at Seres. “We are working tirelessly alongside our commercial collaborator, Nestlé Health Science, to bring this potentially revolutionary therapeutic to recurrent C. difficile patients, who urgently need safer and more effective treatment options to reduce the likelihood of recurrent disease. We believe SER-109 has the potential to fundamentally transform the management of this very serious disease.”\n\nThe SER-109 ECOSPOR III Phase 3 study (ClinicalTrials.gov identifier: NCT03183128) was a multicenter, randomized, placebo-controlled study. Previously reported topline data indicated the study achieved its primary endpoint at eight weeks post-treatment showing a highly statistically significant 30.2% absolute reduction in the r...