Business
Seres Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Updates
– SER-287 Phase 2b study in patients with mild-to-moderate ulcerative colitis has achieved target enrollment; topline data expected in mid-2021 – – Continued
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– SER-287 Phase 2b study in patients with mild-to-moderate ulcerative colitis has achieved target enrollment; topline data expected in mid-2021 –\n\n– Continued enrollment in SER-109 open label study in recurrent C. difficile infection to support planned BLA filing; potential to be first FDA-approved microbiome therapeutic –\n\n– Conference call at 8:30 a.m. ET today –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc., (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported fourth quarter and full year 2020 financial results and provided business updates.\n\n“Seres continues to make progress executing against our top corporate priorities. We are enrolling our open label study to support a Biologics License Application (BLA) for SER-109, a potential first-ever FDA approved microbiome therapeutic. We have also advanced our clinical pipeline and expanded our core microbiome therapeutic drug discovery and CMC capabilities,” said Eric Shaff, President and Chief Executive Officer of Seres.\n\n“We enter 2021 with a strong balance sheet, poised to continue leading the microbiome therapeutic field. Our pipeline spans infectious diseases, inflammatory diseases, and oncology, and we look forward to continued progress during the year, including our development stage pipeline candidates and earlier stage drug discovery efforts. We are pleased to have achieved target enrollment for the SER-287 ECO-RESET Phase 2b study and look forward to obtaining topline results mid-year, an acceleration compared to our prior projections. Our SER-287 program is another embodiment of our mission to develop product candidates with the potential to fundamentally transform patients’ lives by providing substantial clinical benefit over today’s standard of care,” concluded Mr. Shaff.\n\nProgram and Corporate Updates\n\nSER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved a high rate of sustained clinical response in our Phase 3 clinical trial by repairing the disrupted microbiome in patients with recurrent C. difficile infection (CDI).\n\nIn August 2020, Seres announced positive topline interim results from the SER-109 Phase 3 study, ECOSPOR III. The Phase 3 study (ClinicalTrials.gov identifier: NCT03183128) is a multicenter, randomized, pl...