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 –
– Program represents Seres’ second active clinical program targeting ulcerative colitis, in addition to its ongoing SER-287 Phase 2b study –
SER-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.
SER-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.
“Ulcerative colitis is a serious disease impacting approximately 700,000 individuals in the
The SER-301 Phase 1b study is being conducted in
Seres is entitled to receive a
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 manufactured by fermenting each strain individually and then combining to form drug product. The composition includes strains formulated 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. SER-301 is designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract to modulate pathways linked to gastrointestinal inflammation and to improve epithelial barrier integrity in patients with ulcerative colitis.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the timing and results of our clinical studies, the ability of SER-301 to modulate the microbiome of UC patients, the safety profile of our product candidates, the receipt of milestone payments, the promise and success of microbiome therapeutics, and other statements that are not historical facts.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: We have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; our unproven approach to therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development; our reliance on third parties to manufacture, develop, and commercialize our product candidates, if approved; the ability to develop and commercialize our product candidates, if approved; the potential impact of the COVID-19 pandemic; our ability to retain key personnel and to manage our growth; and that our management and principal stockholders have the ability to control or significantly influence our business. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the