Arcutis Biotherapeutics, Inc. plans to advance its program to develop ARQ-151 (topical roflumilast cream) for the treatment of atopic dermatitis into Phase 3 clinical trials without conducting the previously planned Phase 2b atopic dermatitis trial. The decision follows an End-of-Phase 2 meeting with the FDA. 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) that the Company is developing for atopic dermatitis and psoriasis.

“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,” saysPatrick Burnett, MD, PhD, 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 cream is already undergoing Phase 3 clinical trials for the treatment of plaque psoriasis, with topline data expected in the first half of 2021.