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 –
Excerpt from the Press Release:
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Seres 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).
“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.”
The 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.
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