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 - Seite 2

Discussion of Trial

In the trial, 140 participants with chronic, moderate to severe eczema for at least a year were randomized into three equal cohorts for etrasimod 1 mg, etrasimod 2 mg, and placebo, treated once daily for 12 weeks. At the start of the trial, participants showed an Eczema Area and Severity Index (EASI) equal to or greater than 16, a vIGA score equal to 3 or more, and were affected by AD over 10% or more of their body surface. Of the etrasimod 2 mg participants, 29.8% successfully reduced their clinician-reported vIGA at 12 weeks to 0 or 1 (representing “clear” or “almost clear” skin) and improved by at least 2 points, compared to 13% for placebo (p=0.0450).

ADVISE also included three dermatology-specific patient reported outcomes. Participants gave regular evaluations of their peak pruritis numeric rating scale (PP-NRS), Dermatology Life Quality Index (DLQI) and Patient-Oriented Eczema Measure (POEM).

• For the PP-NRS, individuals in the etrasimod 2 mg cohort showed a statistically significant improvement as early as Week 2, compared to placebo, in their PP-NRS percentage score from baseline at the start of the trial; the etrasimod 2 mg cohort reported peak pruritis dropped 15.3% compared to a drop for placebo of only 1.0% (p=0.0380) at Week 4. This early dramatic drop suggests a rapid onset of action for etrasimod. The PP-NRS also dropped numerically a greater amount at Week 12 for the etrasimod 2 mg cohort (34.1%) than for the placebo cohort (23.9%) (p=0.1549).

• The DLQI measures overall impairment due to a dermatologic condition on a scale of 0 to 30, with 30 representing an extremely large effect on a patient’s life. In assessing their overall DLQI, participants in the etrasimod 2 mg cohort saw statistically significant declines in their degree of impairment, dropping 7.6 points at Week 12 versus a drop of 4.2 points for placebo (p=0.0122).

• Arena believes the POEM patient-reported measure of etrasimod’s efficacy also validated the investigational drug as a potential treatment for AD. The indexing of POEM indicates that as disease severity is reduced, the patient’s life improves. In ADVISE, the etrasimod 2 mg cohort experienced an 8.4 point reduction versus 4 points for placebo (p=0.0045), results that are both clinically and statistically significant.

Etrasimod was generally well-tolerated in ADVISE, and showed a safety profile that was consistent with previous trials of etrasimod. During the trial there were no serious adverse events or opportunistic or serious infections observed. The most common adverse events for participants of >5% and greater than placebo were nausea, constipation, back pain and dizziness.