Everest Medicines said that Velsipity (etrasimod) has shown significant clinical and statistical improvements over placebo in the maintenance period of a Phase 3 clinical trial of patients with moderately-to-severely active ulcerative colitis (UC).
Velsipity offers once-daily oral therapy for patients managing moderately to severely active UC. It selectively binds with sphingosine 1-phosphate (S1P) receptor subtypes 1, 4, and 5.
The drug is approved in the US and the European Union (EU), and other countries where Pfizer is the licensing partner of Everest Medicines.
The positive results were obtained from a multicentre, randomised, double-blind, and placebo-controlled late-stage trial of etrasimod 2mg conducted in Asian countries.
The trial involved 340 patients who had not responded adequately or had an intolerance to conventional therapies, biologics, or Janus kinase (JAK) inhibitors.
During the 12-week induction phase, patients received etrasimod 2mg once daily or placebo.
Responders to the induction treatment were then re-randomised into a 40-week maintenance period, receiving either etrasimod 2mg once daily or placebo.
The primary efficacy endpoints were clinical remission rates at Week 12 of induction and Week 40 of maintenance.
Key secondary endpoints included rates of endoscopic improvement and clinical response at these time points.
Data from the maintenance phase showed significant clinical and statistical improvements favouring Velsipity over placebo across primary and all key secondary endpoints.
Velsipity also showed improvement in secondary measures such as mucosal healing and endoscopic normalisation.
The safety profile of etrasimod was consistent with previous studies, with no new safety concerns identified.
Everest Medicines CEO Rogers Yongqing Luo said: “These positive results are both clinically meaningful and statistically significant, which further demonstrate that etrasimod has the potential to be a breakthrough option for patients with moderately-to-severely active UC.
“The number of UC patients in China is projected to double from 2019 to approximately one million by 2030, highlighting the urgent need for novel treatments. Etrasimod is expected to provide a new oral therapy option with a favourable benefit-risk profile for UC patients.”
Velsipity is said to be the first and only oral therapy for UC approved for patients aged 16 and older in the EU.
Additionally, in Everest Medicines’ territories, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, approved the new drug application (NDA) of Velsipity in April of this year.
