Arena Pharmaceuticals Presents Clinician and Patient Reported Outcomes Data from Phase 2b ADVISE Trial Evaluating Etrasimod in Adult Atopic Dermatitis During a Late-Breaking Session at American Academy of Dermatology VMX

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced additional data at a late-breaking session at the American Academy of Dermatology VMX Experience. Etrasimod, a novel investigational drug candidate to treat moderate-to-severe atopic dermatitis (AD), demonstrated statistical significance in both clinician and patient reported outcomes in the etrasimod 2 mg treatment group of Arena’s ADVISE Phase 2b clinical trial. Etrasimod is a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator. Topline results from the ADVISE Phase 2b clinical trial were announced in November 2020. Today’s results were presented by Emma Guttman-Yassky, MD, PhD, Waldman Professor and Chairwoman, The Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai.

“Etrasimod demonstrated clinically meaningful improvements in both clinical signs of atopic dermatitis and patient reported outcomes in the etrasimod 2 mg treatment group,” Dr. Guttman said. “Additionally, patient reported outcomes in this treatment group were improved as early as 2 weeks after etrasimod treatment was initiated. These results, combined with the fact that etrasimod was generally well-tolerated, are promising for this new mechanism of action for the treatment of atopic dermatitis.”

In the ADVISE trial, Arena Pharmaceuticals evaluated the safety and efficacy of etrasimod in participants with moderate to severe eczema as well as to gain insight into design parameters for a potential pivotal Phase 3 program. Additionally, Arena quantified participants’ assessments of etrasimod’s efficacy using the peak pruritis numeric rating scale (PP-NRS), Dermatology Life Quality Index (DLQI) and Patient-Oriented Eczema Measure (POEM). Given the statistically significant and clinically meaningful improvements in PROs in the etrasimod 2 mg treatment group, coupled with the statistically significant improvements shown on the clinician-observed vIGA scale in the same treatment group, Arena Pharmaceuticals continues to expect to advance etrasimod into a pivotal registrational Phase 3 program for atopic dermatitis.

“The results reported today by Dr. Guttman-Yassky from the ADVISE trial have demonstrated impressive clinical benefit for patients living with moderate to severe atopic dermatitis,” said Paul D. Streck, MD, Senior Vice President, Clinical Development, and Chief Medical Officer. “Together with a safety profile that was consistent with previous trials of etrasimod, we believe both the clinician-based assessments and the patient reported outcomes in the etrasimod 2 mg treatment group provide a strong basis to advance etrasimod to a global Phase 3 program as a potential treatment for atopic dermatitis. If approved, etrasimod has the potential to bring a novel, easily dosed oral therapy to patients who currently face limited treatment options for this chronic and debilitating disease.”