Business
Seres Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Updates
– Data from Phase 3 study of SER-109 in recurrent C. difficile infection expected mid-2020; Potential to be the single pivotal study supporting product
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– Data from Phase 3 study of SER-109 in recurrent C. difficile infection expected mid-2020; Potential to be the single pivotal study supporting product registration with the FDA – \n\n\n– Webcast SER-109 investor event to be held May 27 –\n\n\n– Conference call at 8:30 a.m. ET today –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB) today reported financial results from the first quarter ended March 31, 2020 and provided an operational update.\n\n\n“We were pleased to have recently achieved the important milestone of completing enrollment of our SER-109 Phase 3 ECOSPOR III clinical study in recurrent C. difficile infection, and we look forward to topline results from this study mid-year. In preparation for successful SER-109 clinical data, we are working to prepare for a potential FDA regulatory submission and executing commercial readiness activities,” said Eric D. Shaff, President and Chief Executive Officer at Seres. “During the last several months, the COVID-19 pandemic has presented unprecedented challenges around the world. Amidst the complexity of the current environment, we are very pleased to be advancing toward our Phase 3 data on plan and on time. We continue to monitor the impact on Company operations and are carefully reviewing our development plans, including for our ongoing SER-287 and SER-401 studies. Our objective is to advance these programs toward meaningful, clinically interpretable data readouts as rapidly as possible.”\n\n\nProgram Updates and Corporate Highlights\n\n\nCorporate impact of COVID-19: Seres is closely monitoring how the COVID-19 pandemic is affecting the Company and a number of actions have been implemented to protect employee safety and continuation of business operations. Administrative employees continue their work from home, while laboratory research and development activity remains ongoing, with modifications made to prioritize employee safety.\n\n\nSER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109 is an orally-administered, biologically-derived, live microbiome therapeutic candidate designed to restore the depleted, or dysbiotic, gastrointestinal microbiome of patients with recurrent C. difficile infection (CDI).\n\n\nThis first-in-field microbiome therapeutic candidate has been granted Orphan Drug and Breakthrough Therapy de...