Everest Medicines Announces Successful Phase 3 Trial Results for Etrasimod in Treating Moderately-to-Severely Active Ulcerative Colitis in Asia
Monday, July 15, 2024
Everest Medicines (HKEX 1952.HK) has announced positive results from the maintenance phase of a Phase 3 clinical trial of etrasimod in Asia for moderately-to-severely active ulcerative colitis (UC). VELSIPITY® (etrasimod) is an oral treatment approved in the U.S., E.U., and other regions through a partnership with Pfizer. It is the first advanced oral therapy for UC in patients aged 16 and older in the E.U. In Macau, China, VELSIPITY® received New Drug Application approval earlier this year.
CEO Rogers Yongqing Luo emphasized the clinical significance and statistical robustness of the trial results, highlighting etrasimod's potential as a breakthrough UC treatment. With UC prevalence in China expected to double by 2030, etrasimod aims to offer a favorable benefit-risk profile. Everest plans to submit a New Drug Application to China's National Medical Products Administration this year.
The Phase 3 trial involved 340 subjects across Asia receiving etrasimod or placebo. After 40 weeks of maintenance treatment, etrasimod demonstrated significant improvements over placebo in primary and key secondary endpoints, including clinical remission, mucosal healing, and endoscopic normalization (p<0.0001). Safety findings were consistent with previous studies, with no new concerns identified. Detailed results will be presented at upcoming conferences.
In a separate study presented at AOCC 2024, etrasimod showed significant improvements in Chinese patients during the 12-week induction phase, further supporting its efficacy and safety profile in this population.
VELSIPITY® (etrasimod) is a once-daily oral therapy that selectively binds with sphingosine 1-phosphate (S1P) receptor subtypes 1, 4, and 5. Regulatory approvals have been secured in several countries, underscoring its global potential in treating UC.
Source: everestmedicines.com
