Seres Therapeutics is developing an experimental microbiome therapy for the treatment of ulcerative colitis Failure Beating the placebo in the mid-term test caused the company to close some studies and regroup to evaluate the future of the plan.
Ulcerative colitis is an inflammatory bowel disease that is usually treated with anti-inflammatory drugs that suppress the immune system. Seres in Cambridge, Massachusetts is testing another method: a capsule filled with healthy donor gut bacteria, designed to restore a healthy balance of the gut microbiome.
The Phase 2b study enrolled 203 patients who were randomly assigned to receive one of two doses of SER-287 or a placebo. Although patients tolerated both doses of the experimental therapies well, Seres reported on Thursday that there were no significant clinical differences in the clinical remission rates of the three groups in the study, nor were they statistically significant. In addition, no significant difference was observed between the three groups in the improvement observed through endoscopy.
The interim results are in sharp contrast with the Phase 1 study of 58 patients, which showed that the bacteria delivered by SER-287 were implanted in the patient’s microbiome and clinical remission of mild to moderate ulcerative colitis was observed in the patient. Seres said that the results of the second phase, including microbiome analysis, will be submitted to future scientific meetings.
Seres shares opened at $8.75 per share on Thursday, a drop of nearly 58% from Wednesday’s closing price.
Since the drug failed to prove efficacy in the Phase 2 test, Seres stated that it has decided to close the open label and maintain follow-up portion of the clinical trial. In a statement, CEO Eric Shaff said that the company will conduct “rigorous scientific analysis” to understand the failure of clinical trials and determine the next step for its ulcerative colitis microbiome candidates. Worked in the company before.
Lead Seres drug candidate SER-109 is a potential treatment for relapse Clostridium difficile Infect. Same as SER-287, C. Difference The treatment candidate is a bacterial capsule from a healthy donor. In 2016, SER-109 failed to beat the placebo in the second phase of the study, causing the company’s stock price to fall and causing its scientists to scramble to find answers.
Later re-analysis of clinical trial data determined that some patients who participated in the study did not actually C. Difference Infect. The biotech company tried again to conduct another clinical trial, Published positive preliminary results almost a year agoSeres is currently compiling a safety database to support submissions seeking FDA approval. C. Difference treatment.
SER-109 was developed in cooperation with Nestlé Health Sciences, and Nestlé Health Sciences signed a contract as a research partner in 2016.Earlier this month, the two companies reached an agreement Supplemental Agreement Co-commercialization C. Difference drug. Nestlé paid Seres US$175 million in advance and agreed to pay another US$125 million after the FDA approved the microbiome therapy. According to the agreement, partners will share the profit of SER-109 sales equally.
The previous research agreement with Nestlé paid Seres US$120 million in advance. The agreement covers SER-287 for ulcerative colitis and another ulcerative colitis project, SER-301, which is a “next generation” product composed of a series of cultured bacteria. A phase 1b study is being tested to see whether implanting bacteria from SER-301 can modulate microbial-related metabolites as a way to solve ulcerative colitis.
Photos of Flickr users Ed Osman Through knowledge sharing license
