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Seres Therapeutics Presents Late-Breaking Data from SER-109 Phase 3 ECOSPOR III Study in Recurrent C. Difficile Infection at IDWeek2021
– In ECOSPOR III, investigational microbiome therapy SER-109 was associated with greater reduction of antimicrobial resistance genes in patients with
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– In ECOSPOR III, investigational microbiome therapy SER-109 was associated with greater reduction of antimicrobial resistance genes in patients with recurrent CDI compared to placebo –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced late-breaking data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapeutic for recurrent C. difficile infection (rCDI). SER-109 was associated with significantly greater reduction of antimicrobial resistance genes (ARGs) compared to placebo, with the reduction observed both rapidly (by Week 1) and sustained through Week 8 of the study. These data, presented by Timothy Straub on October 2 at the IDWeek 2021 Virtual Conference, support a potential role for microbiome therapeutics in rapid decolonization of antibiotic resistant bacteria.\n\n“As the GI microbiome is the first-line of defense against colonization with antimicrobial resistant bacteria, this exploratory analysis is critical to understanding the potential of SER-109 and our microbiome pipeline more broadly,” said Lisa von Moltke, M.D., Chief Medical Officer at Seres. “As one of the most urgent bacterial threats in the U.S. and a leading cause of hospital-acquired infection, providing patients with safer and more effective treatment options is at the forefront of our mission as we work to potentially bring the first-ever FDA-approved microbiome therapeutic to those suffering from C. difficile.”\n\nThe SER-109 ECOSPOR III Phase 3 study (ClinicalTrials.gov identifier: NCT03183128) was a multicenter, randomized, placebo-controlled study. Previously reported topline data indicated that the study achieved its primary endpoint at eight weeks and demonstrated a sustained clinical response rate of approximately 88% at eight weeks post-treatment. SER-109 resulted in a 27% absolute reduction of recurrence of CDI compared to placebo at eight weeks post-treatment, which is a relative risk reduction of 68%. In May 2021, Seres presented 24-week clinical data from the study that demonstrated significantly reduced recurrence rates compared to placebo over 24 weeks (21.3% vs. 47.3%, respectively). SER-109 was observed to be well tolerated, with no treatment-related serious adverse events observed in the active arm and a...