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Arcutis Enrolls First Patient in Phase 3 Clinical Trial of Topical Roflumilast Foam (ARQ-154) as a Potential Treatment for Scalp and Body Psoriasis
Topical roflumilast potential “Best-in-Class” topical PDE4 inhibitorScalp and body psoriasis affects more than 8 million patients in the U.S. WESTLAKE
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Topical roflumilast potential “Best-in-Class” topical PDE4 inhibitorScalp and body psoriasis affects more than 8 million patients in the U.S. WESTLAKE VILLAGE, Calif., Aug. 25, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced it had enrolled the first patient in its single Phase 3 clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential treatment for scalp and body psoriasis. Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis. “The symptoms of scalp and body psoriasis, including itch and pain, can negatively impact quality of life for the millions of Americans affected. One challenge for patients with scalp psoriasis is that they often require two or more medications for different areas of the body to manage their disease,” said Patrick Burnett, Ph.D., M.D., FAAD, Chief Medical Officer of Arcutis. “In our previous Phase 2b trial, roflumilast foam was demonstrated to be a safe, well-tolerated, and effective potential treatment for scalp and body psoriasis. We are pleased to initiate this Phase 3 trial, as we believe roflumilast foam, if approved, may represent a much-needed, new standard of care for people with scalp and body psoriasis that is suitable for use in hair-bearing areas, unlike creams and ointments, and does not pose the safety concerns typically seen with topical steroids.” The “A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis” (ARRECTOR) study is a parallel group, double blind, vehicle-controlled pivotal Phase 3 study of the safety and efficacy of ARQ-154 0.3% foam or a matching vehicle administered once-daily in approximately 420 subjects with scalp and body psoriasis ages 12 and older. The co-primary endpoints of the study include the proportion of subjects achieving Scalp-Investigator’s Global Assessment (IGA) success and the proportion of subjects achieving Body-IGA success, with IGA success defined as an IGA score of ‘clear’ or ‘a...