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."

Program Updates:

• Etrasimod atopic dermatitis (AD) ADVISE Phase 2b trial enrollment completed; topline data expected Q4 2020
• Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis (UC) ongoing and on track; ELEVATE UC 12 Phase 3 trial expected to initiate in H2 2020; topline data for both trials expected by year end 2021
• Etrasimod CULTIVATE Phase 2b dose-ranging trial in Crohn's disease (CD) initiated and ongoing; considering options to help facilitate availability of topline data in 2021; withdrawing previously announced overall program guidance based on expected COVID-19 impact on trial execution including site activation and enrollment
• Etrasimod eosinophilic esophagitis (EoE) Phase 2b and alopecia areata (AA) Phase 2 planning ongoing; initiation in 2020 dependent on COVID-19 situation in Q3/4
• Olorinab CAPTIVATE Phase 2b trial in abdominal pain associated with irritable bowel syndrome (IBS-C, IBS-D) ongoing; experiencing some COVID-19 related impact on trial enrollment; topline data expected between Q4 2020 and Q1 2021
• APD418 in acute heart failure (AHF) with Fast Track designation; Phase 1 trial experiencing COVID-19 related impact with trial temporarily paused; topline data expected Q4 2020

Etrasimod, olorinab, and APD418 are investigational compounds, not approved for any use in any country.