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Arcutis to Advance Topical Roflumilast Foam (ARQ-154) into Phase 3 Development for the Treatment of Seborrheic Dermatitis
Phase 3 development to consist of single pivotal trialPreviously reported data demonstrated that roflumilast foam provided statistically significant
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Phase 3 development to consist of single pivotal trialPreviously reported data demonstrated that roflumilast foam provided statistically significant improvement and a favorable safety and tolerability profileRoflumilast foam potential “Best in Class” topical PDE4 inhibitorSeborrheic dermatitis affects 10 million U.S. patients WESTLAKE VILLAGE, Calif., Jan. 20, 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, today announced that it will advance its program to develop topical roflumilast foam (ARQ-154) as a treatment for seborrheic dermatitis into Phase 3 following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The Phase 3 program will consist of a single pivotal trial, which the Company anticipates initiating in the second or third quarter of 2021. Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor. “Following our interactions with the FDA, we are delighted to advance topical roflumilast foam into Phase 3 development for the treatment of seborrheic dermatitis, a disease that affects more than 10 million people in the U.S.,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “Results from our Phase 2 clinical trials with once-a-day topical roflumilast foam demonstrated that it provides statistically significant improvements in signs and symptoms of both seborrheic dermatitis and scalp psoriasis compared to a matching vehicle foam, while also being well tolerated. Unlike creams and ointments, roflumilast foam is suitable for use in hair-bearing areas; unlike steroids, it is expected to be suitable for long-term use, including on the face; and unlike shampoos, it is an elegant, quick drying, leave-in foam that doesn’t need to be rinsed out. If successful in the Phase 3 clinical trial and approved for commercialization, roflumilast foam has the potential to become the standard of care in seborrheic dermatitis.” “Patients are desperate to find new treatment options for seborrheic dermatitis, a common, chronic skin disease affecting the face and scalp that can profoundly affect patie...