Seres Therapeutics, Inc.

SeresModel SER-301 - Investigational, Oral, Rationally-Designed, Fermented Microbiome Therapeutic Ulcerative Colitis

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SER-301 is an investigational, oral, rationally-designed, fermented microbiome therapeutic for the treatment of mild-to-moderate ulcerative colitis (UC). SER-301 is a consortium of multiple bacterial strains that is manufactured by fermenting each strain individually and then combining to form drug product.

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SER-301 is a multifunctional consortium of commensal bacteria designed based on clinical insights from our SER-287 Phase 1b study in UC patients. SER-301 is designed to modulate the following microbiome functions →

Unmet need in UC

UC is a serious chronic condition marked by persistent inflammation in the digestive tract which can greatly reduce an individual’s quality of life, and there is no curative treatment. Though genetic factors contribute to a person’s risk for UC, the relationship between the immune system and the gut microbiome also appears to play a role in triggering the disease.

First-line therapies for UC are only modestly effective. Non-responders have limited treatment options because potent immunosuppressive therapies have serious side effects which are hard to justify in patients with mild-to-moderate disease. An unmet need exists for a safer and more efficacious oral therapy.

SER-301 is designed to improve the symptoms of UC and decrease colonic inflammation by simultaneously acting on multiple disease-relevant pathways to address disease.

Status of clinical program

A Phase 1b trial of SER-301 for the treatment of ulcerative colitis has been initiated in Australia and New Zealand.