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Seres Therapeutics Announces FDA Clearance of IND for SER-155, an Investigational Microbiome Therapeutic for the Prevention of Antibiotic-Resistant Bacterial Infections and Graft-versus-Host Disease (GvHD)
– SER-155 aims to prevent mortality in immunocompromised patients due to gastrointestinal infections, bacteremia and GvHD – – In collaboration with Memorial
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– SER-155 aims to prevent mortality in immunocompromised patients due to gastrointestinal infections, bacteremia and GvHD –\n\n– In collaboration with Memorial Sloan Kettering Cancer Center, Seres will now advance SER-155 into a Phase 1b clinical study –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announces the U.S. Food and Drug Administration (FDA) has indicated studies for SER-155 may proceed under an Investigational New Drug (IND) application. SER-155 is an investigational oral, rationally-designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal antibiotic-resistant bacterial infections, bacteremia and graft-versus-host disease (GvHD) in immunocompromised patients, including patients receiving allogeneic hematopoietic stem cell transplantation (HSCT). Prior published studies by Memorial Sloan Kettering Cancer Center collaborators indicate that HSCT patients with a dysbiotic microbiome are at substantially increased risk for bacterial infections and poor outcomes.\n\n“Antibiotic-resistant bacterial infections represent one of the most pressing public health threats with significant implications for HSCT patients and, more broadly, other cancer and immunocompromised patients,” said Matthew Henn, Ph.D., Chief Scientific Officer at Seres. “SER-155 represents a novel microbiome technology with the potential to address antibiotic-resistant bacterial bloodstream infections and further to modulate host immunomodulatory responses to decrease graft-versus-host disease.”\n\nThe SER-155 Phase 1b study is designed to include approximately 70 patients in both an open-label and a randomized, double-blind, placebo-controlled cohort that will evaluate safety and tolerability before and after HSCT. Additionally, the engraftment of SER-155 bacteria (a measure of pharmacokinetics) and the efficacy of SER-155 in preventing infections and GvHD will be evaluated. Seres developed SER-155 with support from a CARB-X grant, including financial and operational support into Phase 1b. Seres fully owns worldwide rights for commercialization of SER-155.\n\n“This milestone represents another exciting opportunity to support patients through Seres microbiome therapeutic candidates and illustrates the potential for microbiome therapeutics ...