Everest Medicines (HKG: 1952), based in China, has announced positive topline results from a multi-center Phase III clinical trial for Velsipity (etrasimod) in patients with moderate-to-severe active ulcerative colitis (UC). Conducted across various sites in Asia, the trial demonstrated clinically meaningful and statistically significant improvements in the primary endpoint, as well as all key secondary endpoints, including mucosal healing, symptomatic remission, and endoscopic normalization, following a 12-week induction treatment period.
Velsipity, a once-daily oral sphingosine 1-phosphate (S1P) receptor modulator, selectively targets S1P receptor subtypes 1, 4, and 5. The drug received U.S. approval for moderate-to-severe UC in October 2023, with regulatory applications now submitted in multiple markets, including the EU, Canada, Australia, Mexico, Russia, Switzerland, and Singapore. The European Medicines Agency (EMA) is expected to make a decision in early 2024.
The treatment was well tolerated at a dose of 2 mg, with a safety profile consistent with previous studies and no new safety concerns reported. Following the induction phase, patients who responded were re-randomized to receive either 2 mg of etrasimod or a placebo for a 40-week maintenance period. With the number of UC patients in China projected to exceed 1 million by 2030, the demand for innovative treatments is becoming increasingly critical. Everest secured licensing rights for Velsipity in Greater China and South Korea through a deal with Pfizer’s subsidiary Arena Pharmaceuticals in 2017.- Flcube.com
