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A speculative microbiome treatment that Seres Therapeutics is establishing to treat ulcerative colitis failed to beat a placebo in mid-stage screening, leading the business to close parts of the research study and regroup to examine the future of that program.
Ulcerative colitis, a type of inflammatory bowel condition, is usually treated with anti-inflammatory drugs that have the effect of suppressing the immune system. Cambridge, Massachusetts-based Seres is checking an alternative technique: a capsule complete of germs from the guts of healthy donors, which is meant to bring the gut microbiome back to a healthy balance.
The Phase 2b research study enrolled 203 patients who were randomly appointed to get one of two doses of SER-287 or a placebo. Though both dosages of the speculative therapy were well tolerated by clients, Seres reported Thursday that there were no meaningful medical differences and no analytical significance observed in the rates of medical remission among the 3 groups in the research study. There were also no significant differences observed across the 3 groups for enhancement as observed through endoscopy.
The mid-stage outcomes are a plain contrast to the 58-patient Phase 1 research study, which revealed that bacteria delivered by SER-287 engrafted into the microbiome of clients and scientific remission of mild-to-moderate ulcerative colitis was observed in patients. Seres stated that the Phase 2 outcomes, consisting of microbiome analyses, will be submitted for discussion at a future clinical meeting.
Seress shares opened Thursday at $8.75 each, a nearly 58% drop from Wednesdays closing stock rate.
Due to the drugs failure to demonstrate efficacy in Phase 2 screening, Seres stated it has chosen to close the open label and maintenance follow-up portions of the scientific trial. In a declaration, CEO Eric Shaff stated the business would carry out a “strenuous scientific analysis” to comprehend the clinical trial failure and determine the next actions for its ulcerative colitis microbiome prospect. It worked for the business in the past.
Lead Seres healing candidate SER-109 is a potential treatment for frequent Clostridioides difficile infection. Like SER-287, the C. diff restorative prospect is a capsule of bacteria sourced from healthy donors. In 2016, SER-109 stopped working to beat a placebo in a Phase 2 research study, sinking the businesss stock cost and sending its researchers rushing for answers.
Reanalysis of the clinical trial information later on determined that a few of the patients registered in the study did not really have C. diff infection. The biotech tried again with another medical trial, publishing favorable initial outcomes nearly a year back. Seres is currently assembling a security database needed to support a submission seeking FDA approval of the C. diff therapy.
SER-109 was developed in partnership with Nestlé Health Science, which signed on in 2016 as a research partner. Earlier this month, the companies struck up an extra contract to co-commercialize the C. diff drug. Nestlé paid Seres $175 million up front and agreed to pay an extra $125 million upon FDA approval of the microbiome therapy. Under the pact, the partners will share similarly in earnings from sales of SER-109.
The prior research pact with Nestlé paid Seres $120 million up front. That agreement covers SER-287 for ulcerative colitis and another ulcerative colitis program, SER-301, which is a “next-generation” item made up of a collection of cultivated bacteria. A Phase 1b research study is in progress testing to see if engraftment of bacteria from SER-301 can modulate the microbe-associated metabolites as a way of addressing ulcerative colitis.
Picture by Flickr user Ed Uthman through a Creative Commons license.

Both dosages of the experimental treatment were well endured by patients, Seres reported Thursday that there were no significant clinical differences and no statistical significance observed in the rates of clinical remission amongst the 3 groups in the study. Due to the drugs failure to show efficacy in Phase 2 screening, Seres stated it has actually decided to close the open label and upkeep follow-up portions of the medical trial. Seres is currently putting together a safety database needed to support a submission looking for FDA approval of the C. diff therapy.
Nestlé paid Seres $175 million up front and agreed to pay an extra $125 million upon FDA approval of the microbiome treatment. That arrangement covers SER-287 for ulcerative colitis and another ulcerative colitis program, SER-301, which is a “next-generation” item comprised of a collection of cultivated germs.