New long-term safety and efficacy data of investigational roflumilast cream 0.15% in mild to moderate atopic dermatitis will be presented in an oral sessionPreclinical data on ARQ-234, CD200R agonist, for the treatment of atopic dermatitisAdditional presentation of the consistent tolerability profile of topical roflumilast in psoriasis, seborrheic dermatitis, and atopic dermatitis
WESTLAKE VILLAGE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that five abstracts will be presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference, which will take place in Chicago, IL from June 8-10, 2024. Among these presentations will be new long-term safety and efficacy data for roflumilast cream 0.15% in patients ≥6 years of age with mild to moderate atopic dermatitis, and an encore of preclinical data on ARQ-234, a CD200 receptor agonist the Company is investigating for atopic dermatitis.
In addition, the Company will present investigator- and patient-rated local tolerability data evaluating topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis.
“We are committed to providing therapeutic innovation and advancing the standard of care for those living with chronic, immune-mediated skin diseases and look forward to sharing these exciting scientific findings including data for roflumilast cream for adults and children with atopic dermatitis from our INTEGUMENT program,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis. “We also look forward to sharing preclinical data from our pipeline for ARQ-234, a biologic we are developing for the treatment of atopic dermatitis.”
Presentation details follow:
Oral Poster PresentationLong-term Safety and Efficacy of Roflumilast Cream 0.15% in Adults and Children Aged ≥6 Years With Mild to Moderate Atopic Dermatitis:A 52-week, Phase 3, Open-Label Safety TrialPresenting Author: Melinda Gooderham, MD, FRCPCTime: June 10, 1:30 pm CTAbstract number: 634
The following posters will be electronically available for the entirety of the conference and online beginning Saturday, June 8, 2024 at 6:00 pm CT.
Pooled Efficacy, Patient-Reported Outcomes, and Safety of Roflumilast Cream 0.15% From the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Clinical Trials of Adults and Children With Atopic DermatitisSimpson, E et al.ePoster 641
Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients 2 to 5 Years of Age with Mild to Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled TrialEichenfield, L et al.ePoster 639
ARQ-234: a high affinity CD200-Fc fusion protein for the treatment of atopic dermatitisSheridan, J et al.ePoster 637
Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitisBunick, C et al.ePoster 640
About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage 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 has a growing portfolio including two FDA approved products that harness 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 and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X.
INDICATIONSZORYVE cream is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older.
ZORYVE foam, 0.3%, is indicated for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.
IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.
The most common adverse reactions (≥1%) for ZORYVE cream include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).
The most common adverse reactions (≥1%) for ZORYVE foam include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream.
Forward-Looking StatementsArcutis 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 topical roflumilast to advance the standard of care in inflammatory dermatological conditions. 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 27, 2024, 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.
Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsasheldon@arcutis.com
InvestorsLatha Vairavan, Vice President, Finance and Investor Relationslvairavan@arcutis.com
