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Arcutis Initiates Phase 3 Clinical Trial of Topical Roflumilast Cream (ARQ-151) as a Potential Treatment for Atopic Dermatitis in Pediatric Patients Between the Ages of Two and Five Years
Roflumilast cream potential “Best in Class” topical PDE4 inhibitorAtopic dermatitis affects approximately 19 million patients in the U.S.The Company
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Roflumilast cream potential “Best in Class” topical PDE4 inhibitorAtopic dermatitis affects approximately 19 million patients in the U.S.The Company anticipates topline data in the second half of 2022 WESTLAKE VILLAGE, Calif., April 12, 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 it initiated a pivotal Phase 3 clinical trial evaluating topical roflumilast cream (ARQ-151) as a potential treatment for mild-to-moderate atopic dermatitis (AD) in patients between the ages of 2 and 5 years old. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is developing for plaque psoriasis and AD. “Young children suffering from atopic dermatitis often struggle with intense, persistent itching that can lead to damage caused by scratching, and that can negatively impact quality of life for both the child and the caregiver,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “Since the majority of atopic dermatitis patients are children, safety is particularly important. We are pleased to initiate this pivotal Phase 3 trial because we believe topical roflumilast has the potential to eliminate the need to compromise between safety, tolerability, and efficacy. In clinical trials, roflumilast cream has demonstrated a favorable safety and tolerability profile, and importantly, unlike steroids, it is safe to use chronically. In a previous Phase 2 trial, topical roflumilast has also shown encouraging efficacy in adult patients with atopic dermatitis. If approved, roflumilast cream may offer an additional treatment option to physicians and parents with otherwise limited choices.” The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (or INTEGUMENT-PED) is a Phase 3, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.05% or vehicle is applied once daily for 4 weeks to patients between the ages of 2 and 5 years old with mild-to-moderate AD involving ≥3% body surface area (excluding the scalp, palms, soles...