Inflammatory Bowel Disease
Seres Therapeutics’ development candidate, SER-287, is an investigational oral microbiome therapeutic for the treatment of Inflammatory Bowel Disease (IBD).
Ulcerative colitis, a form of Inflammatory Bowel Disease (IBD) is a serious chronic condition affecting approximately 700,000 individuals in the United States. The disease results in inflammation of the colon and rectum and can result in debilitating symptoms, including abdominal pain, bowel urgency and diarrhea.
SER-287 is an oral therapy being developed as a potential treatment for ulcerative colitis (UC). SER-287 is currently being evaluated in a Phase 1b study in patients with mild to moderate UC. Future development in other forms of IBD are under consideration.
SER-287 is the first microbiome therapeutic candidate to reach clinical-stage development in a chronic disease, and the first in an indication outside of infectious disease.
The development of SER-287 for UC is supported by a growing body of evidence suggesting that UC is marked by an imbalance of bacteria (dysbiosis) in the gut, and that treating that dysbiosis may lead to a meaningful clinical impact. Current medical therapies remain imperfect for the treatment of UC with a focus on suppressing the immune system. SER-287 represents a novel and unique method to treat UC, which, rather than suppressing the immune system, may reduce the triggers of immune activation.
The randomized, placebo-controlled multiple dose Phase 1b study of SER-287 is expected to enroll up to 55 subjects with active mild-to-moderate UC who are failing current therapies. The endpoints of the study include the change in microbiome and clinical response resulting from SER-287 treatment, as well as evaluation of safety. The study is being conducted in the United States.
The clinical development of SER-287 to treat UC is supported by preclinical studies in multiple animal models of colitis that provide evidence that SER-287 administration results in reduced pathology. Recently published clinical reports furthermore suggest that modulation of the microbiome through repetitive fecal microbiota transplants may lead to meaningful clinical response in certain UC patients 1.
SER-287 is an oral capsule developed using Seres’ proprietary microbiome therapeutics platform. It is a biologically sourced therapeutic candidate comprised of a complex and diverse bacterial spore ecology. In addition to SER-287, Seres’ development pipeline includes SER-301, a rationally designed, synthetic product comprised of in vitro cultured bacterial species for development in UC and other chronic gastrointestinal disorders with high unmet medical need.
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1. Moayyedi, P, et al. Gastroenterology. 2015; Rossen, N, et al. Gastroenterology 2015
2. Paramsothy S. et al., Multi-donor intense faecal microbiota transplantation is an effective treatment for resistant ulcerative colitis: a randomised placebo-controlled trial, oral presentation from European Crohn’s and Colitis Foundation meeting, 2016.