Business
Seres Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Updates
– Topline data from SER-109 Phase 3 study in recurrent C. difficile infection expected in August 2020; Potential to be the single pivotal study supporting
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– Topline data from SER-109 Phase 3 study in recurrent C. difficile infection expected in August 2020; Potential to be the single pivotal study supporting FDA product registration – \n\n\n– Company continues to advance multiple additional clinical-stage microbiome therapeutic programs, including SER-287, SER-301, SER-401 and SER-155 –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB) today reported financial results from the second quarter ended June 30, 2020, and provided an operational update.\n\n\n“In the coming weeks, we are eagerly looking forward to topline results from our SER-109 Phase 3 study in recurrent C. difficile infection. We believe that positive ECOSPOR III data would be an important advance for the C. difficile community. Recurrent C. difficile infection is a debilitating and deadly disease and there is a tremendous need for a safe, FDA-approved treatment that prevents disease recurrence. In addition, we expect that positive ECOSPOR III results would also be a validating milestone for Seres’ pipeline of microbiome therapeutics. Based on prior FDA discussions, we expect that clinically compelling data could support a regulatory filing with the FDA for SER-109 product approval. The SER-109 Phase 3 study could potentially enable a first-in-class approved therapy designed to target the underlying cause of this devastating disease,” said Eric D. Shaff, President and Chief Executive Officer at Seres. “In addition to SER-109, we have made continued progress advancing our pipeline of promising microbiome therapeutic development candidates, including SER-287, SER-301, SER-401 and SER-155. Each program is targeting a serious disease, and each has the potential to transform the standard of care. Across our portfolio, we are driving towards meaningful, clinically interpretable datasets to enable well-informed decisions on future development.”\n\n\nProgram Updates and Corporate Highlights\n\n\nSER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection (CDI): Seres previously reported the completion of enrollment in the SER-109 Phase 3 ECOSPOR III study (ClinicalTrials.gov identifier: NCT03183128). The multicenter placebo-controlled study enrolled 182 patients with multiply recurrent CDI who were randomized 1:1. ECOSPOR III study results remain blinded to the Company and topline st...