US-based Arena Pharmaceuticals has completed patient enrolment in a Phase II clinical trial of investigational candidate etrasimod to treat ulcerative colitis (UC).
Etrasimod is an oral modulator of sphingosine-1-phosphate (S1P) receptor and is being developed to selectively deliver systemic and local cell modulation to S1P receptor subtypes 1, 4, and 5.
Designed for autoimmune diseases, the investigational candidate features improved pharmacology and pharmacokinetics with fast onset of action and rapid t-lymphocytes recovery.
The randomised, double-blind, placebo-controlled, parallel-group, dose-ranging Phase II trial recruited a total of 157 patients with moderate-to-severe UC to assess the safety, dose response, and tolerability of 1mg and 2mg etrasimod over a period of 12 weeks.
Arena Pharmaceuticals research and development (R&D) executive vice-president and chief medical officer Preston Klassen said: “A significant unmet need exists across a range of autoimmune conditions including UC, and we are excited to have fully enrolled this study for etrasimod, meeting the high-end of our targeted range.
“Given etrasimod’s oral route of administration and optimised profile, we believe it has the potential to deliver broad clinical utility.”
The Phase II trial will evaluate efficacy endpoints such as improvement in response, the Mayo clinical score, remission, and mucosal healing, compared to placebo.
Results from the trial are scheduled to be available in Q4, 2018.
Etrasimod is also being studied in different Phase IIa trial for dermatologic extraintestinal manifestations of inflammatory bowel disease (IBD), pyoderma gangrenosum, and primary biliary cholangitis.