Arcutis Biotherapeutics to Showcase Long-term Safety, Efficacy, and Patient-Reported Outcomes of Roflumilast Cream for Chronic Plaque Psoriasis at Innovations in Dermatology

Virtual Spring Conference 2021

Poster presentations highlight new data for roflumilast cream, including long-term safety and efficacy results in adults with chronic plaque psoriasis

WESTLAKE VILLAGE, Calif., March 17, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, will present safety, efficacy, and patient-reported outcomes from its Phase 2 open-label long-term safety study investigating roflumilast 0.3% cream in adult patients with mild-to-severe chronic plaque psoriasis at the Innovations in Dermatology: Virtual Spring Conference 2021.

“Psoriasis can significantly impact all aspects of a patient’s life, including adverse physical, emotional, and social effects,” said Dr. Linda Stein Gold, MD, Henry Ford Health System and Chair, Innovations in Dermatology. “Current topical treatments for plaque psoriasis are often ineffective for long-term treatment, are not well tolerated, or are ill-suited for use in some areas of the body. We are excited to present data demonstrating that roflumilast addresses these limitations with the added benefit of a favorable long-term safety and efficacy profile.”

A poster presentation will feature new long-term efficacy and safety data on topical roflumilast 0.3% cream at 52- to 64-weeks (Dr. Linda Stein Gold). Additionally, two poster presentations will feature analyses of improved burden of signs and symptoms and improved itch severity (Dr. Leon Kircik), and itch-related sleep loss in adults with chronic plaque psoriasis (Dr. Linda Stein Gold) from the original Phase 2b study of roflumilast cream over a 12-week treatment period.

Arcutis also recently released positive topline data from the pivotal Phase 3 studies of roflumilast cream in plaque psoriasis, and plans to present the full results of those studies in the near future, as well as submit a New Drug Application later this year.

In addition to the plaque psoriasis presentations, Dr. Melinda Gooderham will present the results from the Phase 2 study of roflumilast cream 0.15% and 0.05% in patients with mild-to-moderate atopic dermatitis.

“Existing topical treatments prescribed to psoriasis patients have significant shortcomings, which lead to difficult trade-offs between efficacy, safety, and tolerability,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “These data reinforce our conviction that topical roflumilast, if approved by the FDA, has the potential to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions by reducing the need to make such trade-offs.”