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Arcutis Biotherapeutics to Accelerate ARQ-151 (Topical Roflumilast Cream) into Phase 3 Trials for the Treatment of Atopic Dermatitis Following End-of-Phase 2 Meeting with FDA
Progression to Phase 3 clinical trials represents significant acceleration of atopic dermatitis development programPreviously reported data demonstrated
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Progression to Phase 3 clinical trials represents significant acceleration of atopic dermatitis development programPreviously reported data demonstrated evidence that roflumilast cream provided symptomatic improvement and a favorable tolerability profileRoflumilast cream is a novel PDE4 inhibitor being developed as a once-daily topical cream for atopic dermatitis and psoriasis WESTLAKE VILLAGE, Calif., Sept. 08, 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 plans to advance its program to develop ARQ-151 (topical roflumilast cream) for the treatment of atopic dermatitis into Phase 3 clinical trials following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), without conducting the previously planned Phase 2b atopic dermatitis trial. The Company now anticipates initiating pivotal Phase 3 clinical trials in late 2020 or early 2021. ARQ-151 is a once-daily topical cream formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is developing for atopic dermatitis and psoriasis.\n “Following our interactions with the FDA, we are delighted to be able to accelerate the development of topical roflumilast cream into Phase 3 trials for the treatment of atopic dermatitis, a disease that affects almost 20 million people in the U.S., of which approximately 60% are children,” said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis’ Chief Medical Officer. “Results from previous clinical trials have shown that our simple, easy-to-use, once-a-day topical roflumilast cream provided efficacy results similar to those seen with topical JAK inhibitors or mid-potency steroids while also being well tolerated, which is critical in children. By delivering efficacy that enables meaningful symptomatic improvement and a favorable safety and tolerability profile that supports chronic use for patients with atopic dermatitis, topical roflumilast has the potential to overcome the significant shortcomings of existing therapies, which could mitigate the need for dermatologists and patients to make trade-offs in efficacy, safety and tolerability.” Roflumilast...