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Seres Announces Preliminary SER-287 Phase 2b ECO-RESET Study Microbiome Data Analysis

Microbiome data demonstrate the successful engraftment of SER-287 –

– Microbiome assessments suggest potential for biomarker-based patient selection –

– Company continues to evaluate SER-287 study data, and available preliminary SER-301 Phase 1b study clinical and microbiome data, to inform plans for continued development in ulcerative colitis –

Excerpt from the Press Release:

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today 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.

“Our SER-287 Phase 2b data suggests that there may be an opportunity to utilize biomarker-based patient selection in our future UC development efforts. We continue to evaluate SER-287 study data, while also examining preliminary SER-301 Phase 1b study clinical and microbiome data, including analysis of changes in disease-relevant metabolites. We expect to provide a further update on these programs and our plans for future development in UC in the coming months,” said Eric Shaff, Chief Executive Officer at Seres.

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