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Seres Therapeutics Announces Completion of Rolling BLA Submission to FDA for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection
– Investigational therapeutic SER-109 has the potential to become the first-ever FDA-approved oral microbiome therapeutic – – Anticipated product launch in
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– Investigational therapeutic SER-109 has the potential to become the first-ever FDA-approved oral microbiome therapeutic –\n\n– Anticipated product launch in the first half of 2023 –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SER-109 for the prevention of recurrent C. difficile infection (rCDI). SER-109 is an entirely new treatment modality that shows promise to improve the current standard of care for rCDI.\n\n“Completing this BLA submission marks a key milestone for Seres and, more importantly, a potential turning point for the treatment of nearly 170,000 cases of recurrent C. difficile infection each year in the United States alone,” said Lisa von Moltke, MD, Chief Medical Officer at Seres. “We look forward to continuing to work with the FDA on the review of this BLA so that, if approved, we can bring this therapeutic candidate to patients as quickly as possible with our collaborator, Aimmune Therapeutics, a Nestlé Health Science Company.”\n\nSER-109 has FDA Breakthrough Therapy designation, which provides the potential for priority review of the BLA. If granted, Seres anticipates the potential approval and launch of SER-109 in the first half of 2023, with SER-109 potentially becoming the first ever FDA-approved oral microbiome therapeutic.\n\n“After well over a decade of research, Seres has established strong leadership in the development of microbiome therapeutics with a promising pipeline,” said Eric Shaff, President and Chief Executive Officer at Seres. “We are conducting key pre-commercialization activities, including market education with appropriate health care professionals as well as payer engagement, and we continue to scale up manufacturing operations to produce SER-109 commercial supply in preparation for launch.”\n\nThe submission is supported by the results of two Phase 3 studies: ECOSPOR III (NCT03183128) and ECOSPOR IV (NCT03183141). The ECOSPOR III study was a multicenter, randomized, placebo-controlled study, results of which were published in the New England Journal of Medicine. ECOSPOR III achieved its primary endpoint demonstrating that SER-109 was superior to place...