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Seres Therapeutics Announces Initiation of Phase 1b Trial of SER-301 for the Treatment of Ulcerative Colitis
– SER-301 is designed to target the physiological triggers of inflammation believed to be central to the underlying pathology of ulcerative colitis – –
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– SER-301 is designed to target the physiological triggers of inflammation believed to be central to the underlying pathology of ulcerative colitis –\n\n– Program represents Seres’ second active clinical program targeting ulcerative colitis, in addition to its ongoing SER-287 Phase 2b study –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB) today announced that it has dosed the first patient in its Phase 1b trial evaluating SER-301 for the treatment of active mild-to-moderate ulcerative colitis (UC). SER-301 is an oral, rationally-designed microbiome therapeutic designed to dampen the aberrant gastrointestinal inflammation central to ulcerative colitis and induce clinical remission in patients suffering from active UC.\n\nSER-301 is designed to modify the gastrointestinal microbiome and microbe-associated metabolites to modulate multiple pathways associated with ulcerative colitis. SER-301 is a consortium of bacteria designed using Seres’ reverse translational discovery platform that incorporates analysis of microbiome biomarkers from human clinical data and preclinical assessments using human cell-based assays and in vitro and in vivo disease models. SER-301 is designed to reduce induction of pro-inflammatory activity, improve epithelial barrier integrity and TNF-α driven inflammation in intestinal epithelial cells, and modulate UC-relevant anti-inflammatory, innate and adaptive immune pathways. The design of SER-301 incorporated learnings obtained through the Company’s prior SER-287 Phase 1b clinical study conducted in patients with ulcerative colitis. SER-287 Phase 1b study results demonstrated favorable pharmacodynamic changes, signals of clinical activity, and a favorable safety profile.\n\nSER-301 was developed with innovative and novel manufacturing methods that do not require human donor material. It includes strains delivered in spore form and strains fermented in non-spore (vegetative) form. The product candidate is delivered using enterically-protected technology designed to release in the colon. GMP manufacturing technologies developed through the SER-301 program broaden the breadth of biology that can be incorporated into Seres’ microbiome therapeutics.\n\n“Ulcerative colitis is a serious disease impacting approximately 700,000 individuals in the U.S. alone, and effective patient ma...