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Arcutis Announces First Patient Enrolled in Phase 3 Clinical Trial of Topical Roflumilast Foam (ARQ-154) as a Potential Treatment for Seborrheic Dermatitis
Topical roflumilast potential “Best-in-Class” topical PDE4 inhibitorSeborrheic dermatitis affects 10 million patients in the U.S.Potential first new topical
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Topical roflumilast potential “Best-in-Class” topical PDE4 inhibitorSeborrheic dermatitis affects 10 million patients in the U.S.Potential first new topical treatment for seborrheic dermatitis in decadesThe Company anticipates topline data in the second or third quarter of 2022 WESTLAKE VILLAGE, Calif., July 12, 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 enrollment of the first patient in its single pivotal Phase 3 clinical trial evaluating topical roflumilast foam (ARQ-154) as a potential treatment for seborrheic dermatitis. 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 seborrheic dermatitis and scalp psoriasis. “The symptoms of seborrheic dermatitis can have a significant, negative influence on quality of life and can cause psychological distress for millions of affected Americans. Despite that, no novel treatments have been developed for this chronic skin condition in decades, and current topical treatments frequently provide inadequate efficacy or pose safety concerns that limit their use,” said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer of Arcutis. “In our Phase 2 trial, roflumilast foam was demonstrated to be an effective, safe, and well-tolerated treatment for seborrheic dermatitis. We are now pleased to initiate this single Phase 3 pivotal trial, as we believe roflumilast foam, if approved, has the potential to become a much-needed new standard of care for people with seborrheic dermatitis. Unlike most treatments, roflumilast foam is suitable for all body areas, including hair-bearing areas and the face, and does not pose the safety concerns typically seen with topical steroids.” The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) is a Phase 3, parallel group, double blind, vehicle-controlled study of the safety and efficacy of roflumilast 0.3% foam administered once-daily in approximately 450 subjects ages nine and older with moderate to severe seborrheic dermatitis. T...