US-based Seres Therapeutics has reported positive topline results from a Phase Ib placebo-controlled induction trial of SER-287 in patients with mild-to-moderate ulcerative colitis (UC), who were failing current therapies.
SER‐287 is a biologically sourced, oral formulation containing a consortium of live bacterial spores that is being developed for UC and other forms of inflammatory bowel disease.
It is understood to act through a new mechanism of action by modulating the dysbiotic microbiome, reducing inflammation without immunosuppression effects.
A total of 58 patients were treated in the randomised, double-blinded, placebo-controlled, multiple-dose, induction trial and data showed that SER-287 resulted in a benefit in clinical remission rates and an improvement in endoscopic scores.
From this, 24 patients were classified as having mild disease, while 33 patients had moderate disease.
The company noted that study subjects exhibited pre-study disease activity despite use of current therapies in a majority of subjects, which included 5-amino-salacylic acid, low dose corticosteroids, or immunomodulatory therapy.
Seres president, chief executive officer and chairman Roger Pomerantz said: "We are extremely pleased with these SER-287 Phase Ib efficacy and safety study results. The clinical data demonstrates the potential for microbiome therapeutics to provide an effective and safer alternative treatment modality for patients suffering from ulcerative colitis.
"Based on the strength of this data, Seres intends to work expeditiously to advance SER-287 into more advanced development studies. We plan to further evaluate SER-287 in mild, moderate and severe forms of Ulcerative Colitis, in maintenance after induction therapy, and we also intend to assess development in Crohn’s disease, and pediatric forms of inflammatory bowel disease.
"We expect to discuss this data with the FDA as soon as possible, to determine the most accelerated path to advance SER-287 development.”
During the Phase Ib trial, patients were randomly assigned to one of three SER-287 treatment arms or a placebo arm for an eight-week treatment period.
According to the company, no clinically significant safety or tolerability findings were observed, while microbiome study results are expected to be reported in the coming months.