Seres Therapeutics, Inc. Announces Preliminary SER-287 Phase 2b ECO-RESET Study Microbiome Data Analysis
December 16, 2021 at 07:00 am EST
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Seres Therapeutics, Inc. announced preliminary microbiome data analyses from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC). Following the topline clinical data readout in July, which noted that the SER-287 Phase 2b study did not achieve its primary endpoints, analysis of the microbiome data demonstrated the successful engraftment of SER-287 bacterial species. The Company continues to conduct analyses on its SER-287 and SER-301 UC clinical stage programs to inform next steps for further development. Based on the SER-287 Phase 2b microbiome data analyses, engraftment of SER-287 bacteria was statistically significant in patients receiving SER-287 versus placebo (p = 0.001 at all timepoints). The magnitude and kinetics of engraftment were comparable to Seres Phase 1b study. However, unlike the Phase 1b study, anticipated changes in disease-relevant metabolites post-administration with SER-287 in the Phase 2b study were not observed. Analysis of the genomic and metabolomic data characterizing the microbiome of SER-287 study participants at baseline and post dosing suggest potential biomarkers for inclusion in future development efforts. UC is a biologically and clinically heterogeneous disease and the Company believes that a biomarker-based patient selection approach may enable future development to focus on individuals most amenable to a microbiome-based therapeutic intervention.
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).