Arcutis Announces Acceptance of Late Breaking Abstract in Atopic Dermatitis Among Five New Topical Roflumilast Data Being Presented at the American Academy of Dermatology Annual Meeting Late breaking sessions to highlight new data from the INTEGUMENT-PED trial evaluating roflumilast cream 0.05% in children ages 2-5 with atopic dermatitis WESTLAKE VILLAGE, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced five presentations at the 2024 American Academy of Dermatology (AAD) annual meeting, which will take place in San Diego, CA from March 8 - 12, 2024. Among these presentations will be late-breaking clinical data on roflumilast cream 0.05% in patients 2 to 5 years of age with mild to moderate atopic dermatitis from the pivotal INTEGUMENT-PED Phase 3 randomized controlled trial. “Our significant presence at this year’s AAD is a testament to our commitment to bringing meaningful innovation in immuno-dermatology, and building on the body of evidence supporting our topical roflumilast development program. In particular, we are excited to be participating in the late breaking data presentations with new results from INTEGUMENT-PED, as part of our atopic dermatitis clinical program,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis. “We appreciate the opportunity to participate in the AAD and other medical meetings to engage with our peers and progress the medical dermatology field.” Presentation details follow:
Late Breaking Data Presentation
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 Trial Presenting Author: Dr. Lawrence Eichenfield
Time: March 10, 2024, 2:30 PM PT
Presenting Author: Dr. Mark Lebwohl
Time: March 9, 2024, 3:25 PM PT
Room: Upper Level, Sails Pavilion, Poster Center 2
The following posters will be electronically available for the entirety of the conference and online beginning Friday, March 8, 2024:
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 Dermatitis IMPORTANT SAFETY INFORMATION
Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.
Forward-Looking Statements
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 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. Amanda Sheldon, Head of Corporate Communications
Latha Vairavan, Vice President, Finance and Investor Relations
Investor Relations Advisory Solutions
derek.cole@iradvisory.com