WESTLAKE VILLAGE, Calif., Sept. 20, 2022 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of the American Medical Association (JAMA) published positive results from two pivotal Phase 3 studies (DERMIS-1 and DERMIS-2) evaluating roflumilast cream 0.3% as a once daily, topical treatment for chronic plaque psoriasis. The study, which was published in the September 20 issue of JAMA, found that treatment with roflumilast cream resulted in significant improvements across multiple efficacy endpoints including plaque clearance and itch at eight weeks in adults and adolescents with plaque psoriasis compared to vehicle. ZORYVE was approved for topical use of plaque psoriasis, including intertriginous psoriasis, for use in adults and adolescents in July 2022.
“These data highlight the robust efficacy of ZORYVE as a novel non-steroidal treatment option for individuals with plaque psoriasis. Both studies met the primary endpoint of IGA success and demonstrated rapid clearance of plaques and reduction of itch,” said Patrick Burnett, M.D., Ph.D., Chief Medical Officer of Arcutis. “Coupled with ZORYVE’s favorable safety and tolerability data, these results reinforce that ZORYVE can offer patients a single topical therapy for use on all psoriasis-affected areas – including hard to treat areas such as elbows and knees and intertriginous areas. We are thrilled that such a prestigious journal has published the results of our pivotal Phase 3 trials.”
“The itch that can occur in patients with chronic plaque psoriasis has negative effects on a patients’ quality of life,” said Mark Lebwohl M.D., FAAD, principal investigator and Dean for Clinical Therapeutics and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai; and a paid consultant and investigator for Arcutis. “The data from these studies demonstrated that ZORYVE was effective in providing a rapid and significant reduction in itch as early as week two, and significantly improved itch-related sleep loss and scores on the Dermatology Life Quality Index (by week six). In addition, ZORYVE rapidly cleared plaques in patients with mild, moderate, and severe disease, as well as in intertriginous areas.”
The “Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two (or DERMIS-1 and DERMIS-2) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or matching vehicle cream were applied once daily for eight weeks to subjects age 2 years and above with mild, moderate, or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects.
In both studies, significantly more patients treated with roflumilast cream reached IGA Success at week eight compared to the control group of vehicle-treated patients (DERMIS-1: 42.4% vs 6.1%; DERMIS-2: 37.5% vs. 6.9%, respectively, P<0.001 for both). Patients with clinically significant itch, as measured by a baseline Worst Itch Numerical Rating Scale (WI-NRS) of greater than or equal to four, achieved a 4-point reduction in WI-NRS at week eight (DERMIS-1: 67.5% vs 26.8%; DERMIS-2: 69.4% vs 35.6%, P<0.001). Improvement in itch was observed by two weeks, the earliest timepoint measured (DERMIS-2: P=0.003), with consistent improvements achieved through week eight.
Other key Phase 3 findings include:
To learn more about the data, visit the full article.
ZORYVE (roflumilast) cream 0.3% is a next generation topical inhibitor of phosphodiesterase-4 (PDE4) and the first topical PDE4 inhibitor to be approved by the FDA for adults and adolescents with plaque psoriasis, including intertriginous psoriasis.
ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
IMPORTANT SAFETY INFORMATION
The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
The most common adverse reactions (≥1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).
Please see full Prescribing Information.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp psoriasis, atopic dermatitis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for ZORYVE to simplify disease management for care of plaque psoriasis; the potential of real-world use results of roflumilast cream, as well as the commercial launch of ZORYVE in plaque psoriasis. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 22, 2022, as amended, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Amanda Sheldon, Head of Corporate Communications
Eric McIntyre, Head of Investor Relations