Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting
Arcutis Biotherapeutics (ARQT) announced significant data from its pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 studies for roflumilast cream 0.15% in treating atopic dermatitis (AD). Results indicated rapid and notable improvements in itch relief within 24 hours of the first application. The studies demonstrated a 75% reduction in Eczema Area and Severity Index (EASI-75) in over 40% of subjects by Week 4, with favorable safety outcomes. Roflumilast cream also met the primary endpoint of IGA Success, showing a vIGA-AD score improvement. The company plans to submit a supplemental new drug application (sNDA) to the FDA later this year.
- 75% reduction in EASI-75 achieved by over 40% of subjects by Week 4.
- Rapid itch relief observed within 24 hours of application.
- Both studies met primary endpoint of IGA Success with statistically significant results.
- Roflumilast cream demonstrated low incidence of adverse events, with no event exceeding 3.5%.
- None.
- New INTEGUMENT-1 and INTEGUMENT-2 data show a rapid and significant reduction in itch as early as 24 hours after the first application of roflumilast cream
0.15% - Rapid and significant improvements were achieved including individuals reaching a
75% reduction of Eczema Area and Severity Index (EASI-75) as early as Week 1 and in Investigator Global Assessment (IGA) Success as early as Week 2 - In both studies, roflumilast cream improved atopic dermatitis across multiple efficacy endpoints while demonstrating favorable safety and tolerability
- Incidences of adverse events were low, with no adverse event occurring in more than
3.5% of subjects in either arm
WESTLAKE VILLAGE, Calif., March 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today presented in a late-breaking clinical trial session at the American Academy of Dermatology (AAD) annual meeting (New Orleans, LA, March 17-21) new data from its INTEGUMENT-1 and INTEGUMENT-2 pivotal Phase 3 studies of roflumilast cream
Both studies met the primary endpoint of 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 (INTEGUMENT-1:
Over
“Atopic dermatitis is a chronic skin disease common in both children and adults where pruritus, or itch, is the most reported and most burdensome symptom, and may cause substantially reduced quality of life and sleep disturbances,” said Lawrence F. Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego, Professor of Dermatology and Pediatrics and Vice-Chair of the Department of Dermatology at UC San Diego School of Medicine, and study investigator. “Importantly, individuals treated with roflumilast cream experienced a significant and rapid improvement in the extent and severity of their atopic dermatitis, adding further to evidence of the potential of roflumilast cream as a treatment option for this disease. Additionally, these pivotal Phase 3 data show that roflumilast cream drove a significant and rapid reduction in itch as early as the first 24 hours, which could be a helpful early indication to children and adults that the treatment is working.”
Roflumilast cream also demonstrated rapid and statistically significant improvements compared to vehicle on key secondary endpoints, with more than
“Atopic dermatitis can have a huge impact on the quality of life for those affected, and also be challenging to treat,” said Julie Block, President and CEO, National Eczema Association. “Thankfully, our understanding of atopic dermatitis continues to grow, and the commitment from companies, such as Arcutis, to develop new treatment options aiming to provide people living with this disease a much-needed relief, is most welcome and appreciated.”
“We are pleased to present these data from our pivotal Phase 3 INTEGUMENT program, which demonstrated significant improvements in atopic dermatitis in children and adults across multiple efficacy endpoints,” said Patrick Burnett MD, PhD, FAAD, Chief Medical Officer of Arcutis. “Roflumilast cream was also shown to be safe and well-tolerated, critical considerations for the treatment of atopic dermatitis. We look forward to the continued development of roflumilast cream
Roflumilast cream
About the INTEGUMENT Phase 3 Trials
The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis” (INTEGUMENT-1 and INTEGUMENT-2) are two identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roflumilast cream
After completing INTEGUMENT-1 and INTEGUMENT-2, individuals were eligible to enroll in an open-label extension study (INTEGUMENT-OLE) evaluating treatment with once-daily roflumilast cream
Arcutis is enrolling a third pivotal Phase 3 trial, the “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (INTEGUMENT-PED) to evaluate roflumilast cream
About Atopic Dermatitis
AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms, and legs. The rash can cover significant areas of the body, in some cases half of the body or more. AD typically begins in early childhood and is chronic. It persists into adolescence and even adulthood in some individuals. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Since a large percentage of AD patients are very young children, safety is a particularly important consideration in treatment selection.
About Roflumilast Cream
Roflumilast cream is a next generation topical PDE4 inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast cream
About ZORYVE®
ZORYVE (roflumilast) cream
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 (≥
Please see full Prescribing Information.
About Arcutis
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 has a growing portfolio that 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 and body psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.
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, among others, statements regarding the potential for roflumilast to be approved for the treatment of adults and children with AD, the potential to use roflumilast cream over a long period of time, or chronically, the potential to use roflumilast cream anywhere on the body, including the face and sensitive areas, timing for anticipated data of INTEGUMENT-PED, the potential sNDA filing and the potential for roflumilast to advance the standard of care in AD and other inflammatory dermatologic 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 28, 2023, 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.
Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com
Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com
FAQ
What were the results of the INTEGUMENT-1 and INTEGUMENT-2 studies for ARQT?
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