Arena Pharmaceuticals, Inc. completed full enrollment of the Phase 2b ADVISE trial evaluating etrasimod, an investigational next-generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator, for the potential treatment of moderate-to-severe atopic dermatitis.
The trial enrolled 140 patients at study sites across the United States, Canada and Australia, with a primary efficacy endpoint of percent change in Eczema Area and Severity Index (EASI) from baseline to week 12. Topline data can be expected in the fourth quarter of 2020.
"Completing enrollment of the ADVISE trial is a significant milestone for Arena, and we are extremely proud that the team was able to meet the high end of our targeted enrollment range, particularly during these challenging times that our industry and society are facing," says Preston Klassen, M.D., M.H.S, Executive Vice President, Head of Research and Development of Arena, in a news release. "Based on the potential best-in-class intrinsic properties of etrasimod, and clinical and non-clinical evidence seen to date, we are committed to driving its development in dermatologic conditions. We believe we have the potential to address the need for a safe and effective oral option for patients living with atopic dermatitis. We look forward to continuing with the execution of this Phase 2b trial and the expected availability of topline data by year-end."
Update on other Arena trials
"We are very pleased that we have completed enrollment of our ADVISE trial and that to date we have kept timelines on track for our global Phase 3 program, ELEVATE UC. On other programs, we continue to see levels of disruption due to the COVID-19 pandemic; therefore, we are withdrawing our prior guidance on newly initiated trials and certain trials in the planning phase, including the evaluation of etrasimod in Crohn's disease, eosinophilic esophagitis, or EoE, and alopecia areata, or AA. We are hopeful that we can initiate both the EoE and AA studies this year and we are considering options for the Crohn's disease program to obtain Phase 2 dose-ranging data in 2021. Since the start of COVID-19, Arena has been vigilant and proactive in dealing with operational complexities due to the impact of this global pandemic," adds Amit D. Munshi, President and Chief Executive Officer of Arena. "Above all else, we will prioritize patient and employee safety. We intend to provide periodic updates as we gain additional clarity."