- Progression to Phase 3 clinical trials represents significant acceleration of atopic dermatitis development program
- Previously reported data demonstrated evidence that roflumilast cream provided symptomatic improvement and a favorable tolerability profile
- Roflumilast 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.
"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 cream is a once-daily topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast) that is under development for atopic dermatitis and psoriasis. Oral roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25-to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis. 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.