Benzinga | Jan 13, 2021 09:01AM EST

Arcutis Initiates Pivotal Phase 3 Clinical Trials Evaluating Topical Roflumilast Cream (ARQ-151) As A Potential Treatment For Atopic Dermatitis

* Roflumilast cream potential "Best in Class" topical PDE4 inhibitor

* Atopic dermatitis affects approximately 19 million patients in the U.S.

* The Company anticipates topline data in the second half of 2022

WESTLAKE VILLAGE, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it has commenced pivotal Phase 3 clinical trials evaluating topical roflumilast cream (ARQ-151) as a potential treatment for atopic dermatitis (AD). 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.

"More than 19 million people in the U.S. suffer from atopic dermatitis, of which at least 60 percent are young children, thereby making safety and tolerability particularly important in this disease," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "Atopic dermatitis is characterized by a defect in the skin barrier, which results in a red, itchy rash that in many cases can cover significant areas of the body. Current treatments often fall short, resulting in patients, parents and physicians having to make trade-offs between efficacy, safety and tolerability."

Dr. Burnett continued, "We are excited to begin our pivotal Phase 3 trials in patients with atopic dermatitis. If approved, roflumilast cream would be the first once-a-day topical nonsteroidal treatment for AD, and would also offer patients a cosmetically-elegant, non-greasy formulation. In clinical trials, roflumilast cream has demonstrated a benign safety and tolerability profile, without the local tolerability or safety issues associated with many other topical AD treatments, and importantly, unlike steroids, it can safely be used chronically. We believe topical roflumilast has the potential to eliminate the need to compromise between safety, efficacy, and tolerability, and we look forward to reporting topline data in the second half of 2022."

The "INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis" 1 and 2 (or INTEGUMENT-1 and -2) are identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle is applied once daily for 4 weeks to subjects 6 years of age and older with mild to moderate AD involving ?3% body surface area.

In each trial, approximately 650 subjects are planned to be randomized 2:1 to either roflumilast cream 0.15% or matching vehicle cream. The primary endpoint of both trials is Investigator Global Assessment (IGA) Success, defined as a Validated Investigator Global Assessment - Atopic Dermatitis (vIGA-AD) score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline at Week 4. Multiple secondary endpoints will also be evaluated, including itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) as well as the proportion of subjects who attain at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4. After completing INTEGUMENT-1 or -2, subjects may be eligible to enroll in a 12month, open label extension study (INTEGUMENT-OLE) evaluating once daily roflumilast cream. The Company anticipates topline data from INTEGUMENT-1 and -2 in the second half of 2022.

Arcutis also plans to initiate a third pivotal Phase 3 study, the "INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients" (or INTEGUMENT-PED) shortly to evaluate roflumilast cream in subjects 2 to 5 years of age with mild to moderate AD.