Arena Completes Full Enrollment of Etrasimod Phase 2 ADVISE Trial for Atopic Dermatitis, Provides Program Updates

-  Phase 2b ADVISE trial evaluating etrasimod in atopic dermatitis (AD) enrollment complete, meeting the high end of targeted enrollment range, topline data expected Q4 2020

 

-  Etrasimod ELEVATE UC Program remains on track

 

-  Updated guidance for newly initiated trials, and certain trials in planning phase

SAN DIEGO, May 26, 2020 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that it has 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.

"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," said Preston Klassen, M.D., M.H.S, Executive Vice President, Head of Research and Development of Arena.  "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."

"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," stated 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."