Business
Seres Therapeutics Reports SER-155 Phase 1b Cohort 1 Results Showing Successful Drug Bacteria Engraftment and Substantial Reduction in Pathogen Domination in the Gastrointestinal Microbiome
– Tolerability profile observed supports continued development in Cohort 2, with no treatment attributed serious adverse events – – Reduction in incidences
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– Tolerability profile observed supports continued development in Cohort 2, with no treatment attributed serious adverse events –\n\n\n– Reduction in incidences of microbiome pathogen domination provides support for intended SER-155 clinical activity –\n\n\n–SER-155 Phase 1b placebo-controlled Cohort 2 data readout anticipated in mid-2024 –\n\n\n– Conference call at 8:30 a.m. ET today –\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported initial clinical data about SER-155. SER-155 is an oral, cultivated bacterial consortia investigational therapeutic designed to prevent enteric-derived infections and resulting blood stream infections, as well as induce immune tolerance responses to reduce the incidence of graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Gastrointestinal (GI) microbiome data from the first 100 days post HSCT in Cohort 1 of the SER-155 Phase 1b open-label study showed the successful engraftment of SER-155 bacterial strains and a substantial reduction in the cumulative incidence of pathogen domination, a biomarker associated with the risk of serious enteric infections and bloodstream infections, as well as GvHD. The tolerability profile observed was favorable, with no serious adverse events attributed to SER-155 administration. Enrollment in the placebo-controlled Cohort 2 portion of the study is ongoing and topline results are anticipated in mid-2024.\n\n\n“We are pleased with these initial SER-155 Phase 1b study results from Cohort 1, which provide encouraging evidence to support our clinical objective of reducing enteric-derived infections, resulting bloodstream infections, and graft-versus-host disease in individuals undergoing allo-HSCT for cancers and other serious conditions,” said Lisa von Moltke, M.D., Chief Medical Officer at Seres. “The tolerability profile of SER-155 was favorable, with no serious adverse reactions associated with SER-155 administration. Enrollment in the placebo-controlled Cohort 2 study is proceeding, and we look forward to gaining further insights into the therapeutic potential of SER-155 to benefit this highly medically compromised patient population.”\n\n\nSER-155 Phase 1b Study Design and Summary of Cohort 1 Results\n\n...