Arcutis Enrolls Last Patient in Phase 2b Clinical Trial Evaluating ARQ-154 (Topical Roflumilast Foam) as a Potential Treatment for Scalp Psoriasis

• Roflumilast foam potential “Best in Class” topical PDE4 inhibitor in foam formulation
• Scalp psoriasis affects more than 2.5 million U.S. patients
• Phase 2b topline data anticipated fourth quarter 2020

WESTLAKE VILLAGE, Calif., July 20, 2020 (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, today announced the completion of enrollment of the Phase 2b clinical trial evaluating ARQ-154 (topical roflumilast foam) as a potential treatment for scalp psoriasis. Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4 inhibitor) that the Company is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp.  The Company now anticipates topline data from this trial in the fourth quarter of 2020.

“An estimated 8.6 million Americans are afflicted with chronic psoriasis, and nearly half of those people have scalp involvement, an area where topical treatment of scalp plaques is complicated by the difficulty of delivering topical drugs under the hair and to the surface of the skin,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “We developed roflumilast foam as a convenient, once daily, easy-to-use foam that is safe for chronic use and appropriate for application in hair-bearing areas, such as the scalp, where a cream, lotion, or ointment is not suitable. We believe roflumilast foam may provide a new treatment option for physicians and patients, with the potential to show significant symptomatic improvement similar to high-potency steroids, while at the same time maintaining a low risk of toxicity or side effects.”

Roflumilast foam is a topical foam formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011.  Roflumilast has shown greater potency (25 to 300 fold) than the two other FDA-approved PDE4 inhibitors.  PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD.  PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.