– Evaluating etrasimod 2 mg in patients with the clinical diagnosis of moderate-to-severe alopecia areata

– There are currently no FDA-approved treatments for alopecia areata

SAN DIEGO, CA, USA I September 1, 2020 IArena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the first subject has been dosed in a Phase 2 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 alopecia areata. The randomized, placebo-controlled trial will evaluate the efficacy and safety of etrasimod 2 mg for 24 weeks in 36 subjects in sites across the United States and Canada.

“It is exciting to see the clinical advancement of an oral agent with a novel mechanism of action for the potential treatment of alopecia areata,” stated Brett King, MD, PhD, Associate Professor of Dermatology, Yale School of Medicine. “With no currently FDA-approved treatment options there is a significant unmet medical need in alopecia areata. I see patients suffer tremendous emotional and psychosocial distress and reduced quality of life as a result of this disease. I look forward to seeing the progress of Arena’s Phase 2 program and the development of etrasimod.”

“Dosing the first patient in our Phase 2 alopecia areata trial is a great accomplishment for the team, furthering our expansion into dermatology,” stated Chris Cabell, MD, MHS, FACC, Executive Vice President, Head of Research and Development, and Chief Medical Officer at Arena. “To date, we have seen preclinical and scientific validation supporting the rationale for moving etrasimod into alopecia areata and other dermatologic conditions. Etrasimod has demonstrated the potential to reduce circulating CD4+ and CD8+ T-lymphocytes. In alopecia areata, this may reduce the T cells available to infiltrate the hair follicle, which may decrease inflammation and restore hair growth. We expect the availability of Phase 2 data in 2021.”

This Phase 2 multicenter, randomized, placebo-controlled trial will assess the safety and efficacy of once-daily etrasimod 2 mg in subjects with moderate-to-severe alopecia areata. The primary endpoint is percent change in Severity of Alopecia Tool (SALT) score from baseline to week 24. The trial will enroll 36 subjects and will be conducted in study sites across the United States and Canada.

About Alopecia Areata
Alopecia areata, or AA, is a T-cell-mediated autoimmune skin disorder with unmet medical need that causes non-scarring patchy hair loss, most often on the scalp. Mild disease typically presents as one or more round or oval bald patches on the scalp. In moderate-to-severe disease, extensive and chronic hair loss occurs, with the most severe forms involving hair loss on the entire scalp (alopecia totalis) or body (alopecia universalis). Patients with persistent moderate-to-severe AA also often suffer emotional and psychosocial distress and reduced quality of life as a result of their hair loss.

About Etrasimod
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, atopic dermatitis and alopecia areata.

Etrasimod is an investigational compound that is not approved for any use in any country.

About Arena Pharmaceuticals
ARENA Pharmaceuticals is a team with a singular purpose – deliver our important medicines to patients.

In a rapidly changing global market, we work with a sense of urgency every day to understand the needs of all our stakeholders, identify bold, sometimes disruptive, ideas to get our medicines to patients, and relentlessly execute until it’s done.

SOURCE: Arena Pharmaceuticals