Seres quietly discloses it has once again altered plans in ulcerative colitis
A month after another setback in its plans to treat ulcerative colitis, Seres Therapeutics quietly disclosed it will not move forward with a Phase Ib trial.
The move, disclosed in an SEC filing Wednesday, puts Seres in a predicament as the Cambridge, MA biotech failed with one potential UC drug, SER-287, last July, and again with another experimental drug last month.
That second attempt, with SER-301, was safe to proceed to the placebo-controlled second cohort in a Phase Ib trial even though outcome data from the 15 patients indicated none of them had achieved clinical remission after 10 weeks of treatment, Seres said on March 1.
With that, the biotech tucked the no-go news into a Wednesday presentation on its website.
“We are very proud of our work and scientific progress and will continue with our research to inform further clinical development efforts in this disease area. Ulcerative colitis remains an area of strategic interest for our company, and we believe that following the workstreams we outlined in this morning’s disclosure could set us up better for future clinical development in UC. No layoffs are planned as a result of this decision,” Seres president and chief executive Eric Shaff said in an emailed statement to Endpoints News.
As the company plots a mid-year approval request for its C. difficile therapeutic — which Seres claims would be the first FDA-greenlit microbiome therapeutic — the company will explore ways to develop treatments for UC based on the trial data from SER-287 and SER-301.
“Clinical data suggest potential for biomarker-based patient selection,” Seres revealed in the presentation. In March, the company said SER-301 led to improvements in endoscopic, stool frequency and rectal bleeding sub-scores for some patients.
In a Phase IIb study last year, Seres said SER-287 did not improve clinical remission rates compared to placebo. That roadblock, which led Seres to close the open-label and maintenance portions of the trial, has led to a stock slump for the biotech over the past nine months.