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Seres Therapeutics Announces Initiation of Enrollment in SER-155 Phase 1b Study Cohort 2 in Individuals Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
– Company anticipates reporting initial SER-155 safety and pharmacological data from study Cohort 1 in the coming months – CAMBRIDGE, Mass.--(BUSINESS
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– Company anticipates reporting initial SER-155 safety and pharmacological data from study Cohort 1 in the coming months –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that enrollment in Cohort 2 in its SER-155 Phase 1b study is underway. SER-155, an investigational oral microbiome therapeutic, is designed to reduce the incidence of gastrointestinal (GI) infections, bloodstream infections, and graft versus host disease (GvHD) in individuals undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\n“We are pleased to advance SER-155 as a potential new medicine for individuals undergoing allo-HSCT, a medically compromised group at substantial risk of life-threatening infections. The development of SER-155 is informed by robust clinical and pharmacologic results from the Phase 3 program evaluating SER-109, our lead microbiome program currently under FDA review for product approval. We believe these data clearly demonstrate the promise of microbiome therapeutics to provide transformative levels of Infection Protection through a novel modality,” said Lisa von Moltke, M.D., Chief Medical Officer at Seres. “While we enroll SER-155 study Cohort 2, we are also continuing to add clinical sites to accelerate recruitment. We look forward to reporting initial SER-155 Cohort 1 safety and pharmacology data in the coming months while expeditiously working to complete the full study.”\n\nThe development of SER-155 is informed by Phase 3 clinical and pharmacological data from Seres’ lead investigational microbiome program, SER-109, showing reductions in the rate of recurrent C. difficile infection in a Phase 3 study, as well as diminished levels of bacterial pathogens in the gastrointestinal tract. SER-155 was designed to decrease the colonization and abundance of bacterial pathogens, including those that can harbor antibiotic-resistance, and to enhance epithelial barrier integrity in the GI tract to both reduce the likelihood of pathogen translocation and decrease the incidence of bloodstream infections. The SER-155 Phase 1b study will assess safety, pharmacology, and the potential impact on GI pathogens, clinical infections and/or GvHD in approximately 70 adults undergoing allo-HSCT. The study is enrolling subjects undergoing in...