Seres SER-109 data for rCDI published, PDUFA action date set for April 26

Seres Therapeutics announced the publication of data from its Phase 3 ECOSPOR IV trial in JAMA Network Open that reinforce previously published results from the Phase 3 ECOSPOR III study on the investigational microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection or rCDI . With nearly 156,000 cases in the U.S., rCDI is a leading cause of hospital-acquired infection and places a significant burden on the healthcare system. "We are proud to see these critical supporting data from the ECOSPOR IV study published in a leading medical research journal. These findings extend our previous results and found that repopulating the GI tract with key protective bacteria via oral delivery can meaningfully reduce the risk of a recurrence of CDI, including in first recurrent patients," said Lisa von Moltke, M.D., Chief Medical Officer at Seres and publication co-author. "Recurrent C. difficile infection places a significant burden on patients, providers and the entire healthcare system and we believe that SER-109, if approved, may provide an important new treatment option for this disease." A Biologics License Application BLA for SER-109 has been submitted to the U.S. Food and Drug Administration FDA and was accepted for Priority Review, with a Prescription Drug User Fee Act PDUFA action date set for April 26 .