Arena Pharmaceuticals announced topline results from the Phase 2b ADVISE clinical trial evaluating etrasimod for the treatment of moderate-to-severe atopic dermatitis (AD). While the trial did not meet the primary endpoint of percent change in Eczema Area and Severity Index (EASI) from baseline to Week 12 , secondary endpoints – including the proportion of patients with a Validated Investigator’s Global Assessment (vIGA) 0 to 1, percent change in EASI-75 and pruritis at week 4 – were all reached with statistical significance. Based on this data, Arena is planning to advance etrasimod into phase 3 trials.
The multicenter, randomized, double-blinded, placebo-controlled ADVISE trial enrolled approximately 140 subjects and was conducted in study sites across the United States, Canada and Australia. In the primary analysis, nearly one-third of patients in the 2 mg etrasimod group achieved clear or almost clear skin, as defined by the validated Investigator Global Assessment (vIGA) – the FDA endpoint for Phase 3 registration. The vIGA improvement was statistically significant versus placebo at 12 weeks. Across the EASI-75 and peak change in pruritis endpoints, etrasimod 2 mg demonstrated early and statistically significant effect at week 4. Etrasimod did not meet the primary endpoint of EASI change from baseline at week 12 as compared to placebo.
Overall, the 12-week study showed no plateau of effect, and the safety profile was consistent with previous trials of etrasimod including low first dose heart rate effect with no titration, and no serious adverse events (SAEs) across the groups.
Arena plans to submit additional data from the ADVISE trial to future medical meetings and for publication in a peer-reviewed journal.
Etrasimod (APD334) is a next generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator. It was designed for optimized pharmacology and engagement of S1P receptor 1, 4 and 5, which may lead to an improved efficacy and safety profile.
About Atopic Dermatitis
Atopic dermatitis (AD) is a serious, chronic immune-mediated disease in which symptoms vary, but often include severe dry skin, itching, patches, swollen skin and raised bumps which may leak fluid.