Seres Therapeutics Presents Late-Breaking Phase 3 Data on Investigational Microbiome Therapeutic SER-109 in Recurrent C. Difficile Infection At American College of Gastroenterology 2021 Annual Scientific Meeting
October 26, 2021 at 07:00 am EDT
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Seres Therapeutics, Inc. 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). New data from an exploratory analysis demonstrate SER-109 reduced the risk of rCDI compared to placebo in patients with risk factors for recurrence, including those taking acid-reducing medications such as proton pump inhibitors (PPIs) and H2 blockers (40.7% of patients). These data, presented by Louis Korman, M.D. on October 26 from 3:25-3:35 PM PT at the American College of Gastroenterology 2021 Annual Scientific Meeting in Las Vegas, may assist healthcare providers in their clinical decision-making on the use of PPIs and H2 blockers in patients at risk for recurrent CDI. The SER-109 ECOSPOR III Phase 3 study (ClinicalTrials.gov identifier: NCT03183128) was a multicenter, randomized, placebo-controlled study. Previously reported topline data demonstrated that the study achieved its primary endpoint where SER-109 was superior to placebo in reducing CDI recurrence at eight weeks reflecting 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% vs. 47%, respectively). SER-109 was observed to be well tolerated in the study, with no treatment-related serious adverse events observed in the active arm and an adverse event profile comparable to placebo. Seres expects both the completed Phase 3 study results and the pending open-label study database to enable a Biologics License Application (BLA) filing in mid-2022.
Seres Therapeutics, Inc. is a commercial-stage microbiome therapeutics company. It is focused on the development and commercialization of a novel class of biological drugs, which are designed to treat disease by modulating the microbiome to restore health by repairing the function of a disrupted microbiome to a non-disease state. Its lead program, VOWST, is to prevent recurrence of Clostridioides difficile infection (CDI) in patients 18 or older following antibacterial treatment for recurrent CDI. Building upon VOWST, it is developing novel microbiome therapeutics, such as SER-155, to specifically target infections and antimicrobial resistance. SER-155, an oral microbiome therapeutic candidate consisting of a consortium of cultivated bacteria, is designed to prevent enteric-derived infections and resulting blood stream infections and induce immune tolerance responses to reduce the incidence of GvHD in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Seres Therapeutics Presents Late-Breaking Phase 3 Data on Investigational Microbiome Therapeutic SER-109 in Recurrent C. Difficile Infection At American College of Gastroenterology 2021 Annual Scientific Meeting