Arena Pharmaceuticals has dosed the first subject in the phase 2 ADVISE clinical trial, which is evaluating etrasimod for the treatment of moderate-to-severe atopic dermatitis (AD).
Etrasimod is a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator.
Atopic dermatitis is considered to be a serious, chronic immune-mediated disease in which symptoms are varied. However, the usual symptoms of atopic dermatitis are severe dry skin, itching, patches, swollen skin and raised bumps which may result in leakage of fluid.
Jonathan I. Silverberg – Associate Professor of Dermatology, Director of Clinical Research, and Director of Patch Testing, at the George Washington University School of Medicine and Health Sciences, said: “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.
“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.”
According to Arena Pharmaceuticals, etrasimod offers systemic and local effects on specific immune cell types and can potentially treat ulcerative colitis, Crohn’s disease, and atopic dermatitis, and other immune-mediated inflammatory diseases.
The ADVISE clinical trial will assess the efficacy and safety of a couple of doses of the S1P receptor modulator for 12-weeks in nearly 120 patients in sites in the US, Canada, and Australia.
The primary endpoint of the ADVISE clinical trial is the percent change in Eczema Area and Severity Index (EASI) from baseline to the twelfth week, followed by a four-week follow-up observation period.
Preston Klassen – Executive Vice President, Head of Research and Development at Arena Pharmaceuticals said: “The decision to move into dermatology, and specifically atopic dermatitis, is founded on scientific, preclinical and early clinical supporting evidence.
“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.”