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Seres Therapeutics Announces Completion of Enrollment in SER-109 Phase 3 ECOSPOR III Study for Recurrent Clostridium difficile Infection and Provides Clinical Pipeline Updates
– Topline ECOSPOR III Phase 3 study data readout timing as planned for mid-2020 – – Potential for ECOSPOR III to be a single pivotal study supporting product
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n – Topline ECOSPOR III Phase 3 study data readout timing as planned for mid-2020 –\n\n\n– Potential for ECOSPOR III to be a single pivotal study supporting product registration with FDA –\n\n\n– Company assessing the impact of COVID-19 on SER-287, SER-401 and SER-301 clinical development programs –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc., (Nasdaq: MCRB) announced today that the Company has completed enrollment of its SER-109 Phase 3 clinical study, ECOSPOR III. SER-109 is an oral, first-in-field microbiome therapeutic candidate that has been granted Orphan Drug and Breakthrough Therapy designations by the U.S. Food and Drug Administration (FDA), and is being investigated for use in preventing recurrent Clostridium difficile infection (CDI).\n\n\n“We are pleased to have achieved this critically important corporate milestone. SER-109 has the potential to be the first FDA-approved therapy for C. difficile infection to treat the underlying cause of this disease, and the first approved microbiome drug for any human condition. We believe SER-109 could fundamentally transform the treatment of patients with recurrent C. difficile infection, a life-altering infectious disease, and we eagerly look forward to topline clinical results in the middle of this year. With compelling Phase 3 ECOSPOR III clinical data, we plan to engage in discussions with the FDA regarding a filing for product approval,” said Eric Shaff, President and Chief Executive Officer of Seres. “We are also working to advance our other promising clinical development candidates in light of the COVID-19 pandemic. This remains an evolving situation and we are carefully reviewing our development plans to determine how to rapidly advance our pipeline toward high-quality data readouts.”\n\n\nSER-109 Study Updates\n\n\nThe SER-109 Phase 3 ECOSPOR III study (ClinicalTrials.gov identifier: NCT03183128) is a multicenter, randomized, placebo-controlled study which has enrolled 181 patients with multiply recurrent CDI to date. ECOSPOR III had been designed to enroll 188 patients. The Company has decided to halt enrollment as a result of the COVID-19 pandemic. Seres believes that ECOSPOR III remains well-powered to evaluate the efficacy of SER-109. The ECOSPOR III study’s primary endpoint is the reduction of CDI recurrence at up to eight weeks following SER-...