Everest Medicines (HKG: 1952), a leading biopharmaceutical company based in China, has announced positive top-line results from a multi-center Phase III clinical study for its Velsipity (etrasimod) in moderate-to-severe active ulcerative colitis (UC) during the maintenance period in Asia. This landmark trial is the largest Phase III study for moderately-to-severely active UC in Asia to date, involving 340 eligible subjects who were randomized to receive etrasimod or a placebo.
The study enrolled patients with an inadequate response or intolerance to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. These patients were then randomized to receive once-daily etrasimod 2mg or placebo for 12 weeks of induction treatment. Those who completed the 12-week induction treatment and responded were re-randomized into a 40-week maintenance period, continuing the same treatment regimen. The data from the maintenance phase demonstrated that etrasimod significantly outperformed placebo in the primary and all key secondary endpoints (p<0.0001), as well as other secondary endpoints, including mucosal healing and endoscopic normalization (both p<0.0001). The safety profile of etrasimod remained consistent with previous studies, with no new safety signals identified.
Velsipity, the investigational drug, is a once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator that selectively binds to S1P receptor subtypes 1, 4, and 5. It has already received regulatory approvals in the US, EU, Canada, Australia, Singapore, UK, and Macau for the treatment of ulcerative colitis.- Flcube.com
