Seres Therapeutics, Inc. (NASDAQ:MCRB) has revealed on Friday in the interim eight-week results of the SER-109 Phase 2 ECOSPOR clinical trial for the prevention of multiply recurrent Clostridium Difficile Infection (CDI) that it did not attain the primary endpoint of minimizing the CDI recurrence relative risk at up to eight weeks.
How Seres Therapeutics Plans to Proceed
Roger Pomerantz, M.D., Seres Therapeutics CEO, Chairman, and President, noted that the latest interim results are unexpectedly far from the positive results from the Phase 1b clinical trial.
Despite not meeting the primary endpoint of the SER-109 Phase 2 ECOSPOR study, Seres Therapeutics, remaining optimistic, will still proceed with it. The company hopes to make the necessary adjustments and changes on the entire clinical trial in cooperation with the US Food and Drug Administration (FDA).
Pomerantz, M.D. reiterated that Seres Therapeutics sees these results as learning grounds to further develop its clinical trial programs that seek to treat CDI and other conditions.
Clinical Trial Design
A total of 89 individuals suffering from multiply recurrent CDI, who had three or more recent recurrences, were enrolled in the randomized, double-blind, placebo-controlled SER-109 Phase 2 ECOSPOR study to determine the safety and efficacy of SER-109 in minimizing the recurrences among patients. The 24-week Phase 2 clinical trial was conducted at 36 centers across the US. CDI recurrences are defined as: 1) diarrhea for two or more consecutive days; 2) positive CDI tests; and/or 3) antibiotic treatment requirement.
Seres Therapeutics Teams Up with Emulate, Inc.
Earlier in July, the company has struck a deal with Emulate to work together on the latter’s Intestine-Chip platform.
According to David Cook, Ph.D., Seres Therapeutics Chief Scientific Officer (CSO) and Executive Vice President (EVP) of Research and Development (R&D), believes that the partnership with Emulate for the Intestine-Chip technology will help improve its efforts to discover and develop new microbiome therapeutics, specifically for inflammatory bowel diseases and other infectious conditions.
Similarly, James Coon, Emulate CEO, is delighted to collaborated with Seres Therapeutics as they bring together new innovations that will advance microbiome therapeutics.
