Arena Pharmaceuticals announced the first subject has been dosed in the Phase 2 ADVISE trial evaluating etrasimod, an investigational next-generation, once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator, for the potential treatment of moderate-to-severe atopic dermatitis (AD). The trial will evaluate the efficacy and safety of two doses of etrasimod for 12-weeks in approximately 120 subjects in sites across the United States, Canada and Australia.
"I am pleased that Arena is currently enrolling patients in its Phase 2 ADVISE study, advancing an oral agent with a novel mechanism of action for the potential treatment of atopic dermatitis," said Jonathan I. Silverberg, MD, PhD, MPH, Associate Professor of Dermatology, Director of Clinical Research, and Director of Patch Testing, at the George Washington University School of Medicine and Health Sciences. "Moderate-to-severe atopic dermatitis remains a disease with significant unmet medical needs. Patients and their families experience great burden on their quality of life and overall health, with negative impacts on physical and emotional well-being, social functioning, and activities of daily living."
"The decision to move into dermatology, and specifically atopic dermatitis, is founded on scientific, preclinical and early clinical supporting evidence," said Preston Klassen, MD, MHS, Executive Vice President, Head of Research and Development at Arena. "We are confident that etrasimod has the potential to be a first-in-class oral therapy in atopic dermatitis, and we look forward to seeing the Phase 2 data in the second half of 2020."
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ADVISE is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study (with an open-label extension) to assess the safety and efficacy of once-daily etrasimod in subjects with moderate-to-severe atopic dermatitis. The primary endpoint is percent change in Eczema Area and Severity Index (EASI) from baseline to week 12, followed by a 4-week follow-up observation period. The ADVISE trial will enroll approximately 120 subjects and will be conducted in study sites across the United States, Canada and Australia.
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.
Etrasimod (APD334) is a next generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator discovered by Arena, and designed for optimized pharmacology and engagement of S1P receptor 1, 4 and 5 which may lead to an improved efficacy and safety profile.
Etrasimod provides systemic and local effects on specific immune cell types and has the potential to treat multiple immune-mediated inflammatory diseases including ulcerative colitis, Crohn's disease, and atopic dermatitis.