Seres -Model SER-287 -Investigational, Oral, Biologically-Derived Microbiome Therapeutic Ulcerative Colitis
SER-287 is an investigational, oral, biologically-derived microbiome therapeutic for the treatment of ulcerative colitis (UC). SER-287 is a consortium of multiple bacterial spores manufactured by fractionating and purifying targeted bacteria from stool of healthy human donors. SER-287 has been granted Fast Track designation and Orphan Drug designation by the FDA. A completed SER-287 Phase 1b clinical study demonstrated a statistically significant difference in the clinical remission rate between patients with active mild-to-moderate ulcerative colitis treated with vancomycin followed by daily SER-287 for 8 weeks compared to the placebo group, and a favorable safety profile.
SER-287 is a multifunctional consortium of commensal bacteria based on human clinical insights. It is designed to modulate the following microbiome functions →
Ulcerative colitis (UC) is a serious chronic condition marked by persistent inflammation in the digestive tract which can greatly reduce an individual’s quality of life. Although the pathogenesis of UC remains unclear, changes in the gastrointestinal microbiome and associated metabolites appear to be important. The relationship between the immune system and the gut microbiome also appears to play a role in 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-287 is designed to improve symptoms and reduce colonic inflammation by acting on multiple disease-relevant pathways.
Status of clinical programSeres has completed enrollment in the Phase 2b ECO-RESET study, designed to assess the safety and efficacy of SER-287 in patients with active mild-to-moderate ulcerative colitis.