Business
Seres Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Updates
– SER-109 Phase 3 study results in recurrent C. difficile infection published in New England Journal of Medicine – Biologics License Application (BLA) filing
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– SER-109 Phase 3 study results in recurrent C. difficile infection published in New England Journal of Medicine\n\n– Biologics License Application (BLA) filing for SER-109 anticipated in mid-2022 –\n\n– Investor webcast highlighted the broad potential of microbiome therapeutics as a novel approach for Infection Protection in medically compromised individuals –\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 2021 financial results and provided business updates.\n\n“The progress made throughout 2021 has set the stage for an exciting year ahead for Seres, highlighted by the anticipated BLA filing for SER-109 with the U.S. Food and Drug Administration (FDA) for recurrent C. difficile infection (rCDI) in mid-2022 which, if approved, we expect to be the first ever microbiome therapeutic” said Eric Shaff, Chief Executive Officer at Seres. “In collaboration with Nestlé Health Science, we are executing on our plans for a successful SER-109 product launch. Together, we are committed to bringing this potentially transformative therapeutic option to patients suffering with rCDI.”\n\n“As highlighted during our recent investor event, we are also advancing our earlier stage efforts in Infection Protection, including the recently initiated SER-155 Phase 1b study to evaluate safety and efficacy in individuals undergoing allogeneic hematopoietic stem cell transplantation. We believe that our microbiome approach has the potential to result in transformative new medicines for Infection Protection, a therapeutic category in great need of innovation,” continued 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 its primary endpoint of superiority to placebo in reducing CDI recurrence in a Phase 3 clinical trial in patients with rCDI. The Company continues to prepare for a BLA filing with the FDA.\n\nSeres has achieved target enrollment in its open-label study of SER-109 in patients with rCDI (ClinicalTrials.gov identifier: NCT03183141), which also admits patients with a single recurrence of rCDI, to expand the SER-109 safety database. Based on FDA ...