Arcutis Announces Positive Results from INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
- Positive results from the INTEGUMENT-PED trial with roflumilast cream 0.05% for pediatric atopic dermatitis
- 25.4% of children achieved IGA Success compared to 10.7% with vehicle
- Significant improvements in EASI-75 and itch reduction
- None.
- Study met the primary endpoint and all secondary endpoints, highly consistent with rapid response from the INTEGUMENT-1 and INTEGUMENT-2 pivotal trials
- For the primary endpoint,
25.4% of children treated once daily with roflumilast cream0.05% achieved Investigator Global Assessment (IGA) Success compared to10.7% of children treated with vehicle (P<0.0001) at Week 4, with significant improvements seen as early as Week 1 39.4% of children treated with roflumilast cream0.05% achieved a75% improvement in Eczema Area and Severity Index (EASI-75), a key secondary endpoint- Roflumilast cream reduced itch, with
35.3% of roflumilast cream treated children achieving a four-point reduction in Worst Itch Numeric Scale (WI-NRS) at Week 4 - Study reinforces well-established, favorable efficacy, safety and tolerability profile of roflumilast cream for both pediatric and adult patients with atopic dermatitis
- Company to host a conference call to discuss results today at 8:30 a.m. ET
WESTLAKE VILLAGE, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the INTEGUMENT-PED pivotal Phase 3 trial of roflumilast cream
Roflumilast cream
“Pediatric atopic dermatitis is a chronic, recurrent inflammatory skin condition that can negatively impact the quality of life of the child and family or caregivers. Children’s skin is uniquely sensitive and finding tolerable therapy is often more challenging. Ideally, sensitive areas such as the face and eyelids need a topical treatment that minimizes stinging and burning and is suitable for long-term use,” said Adelaide A. Hebert, MD, Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston, and INTEGUMENT-PED investigator. “The positive findings from this study of roflumilast cream are highly consistent with the findings from the INTEGUMENT-1 and INTEGUMENT-2 studies. These results further reinforce the safety and efficacy profile of roflumilast cream as a potential treatment option, if approved, for pediatric atopic dermatitis down to 2 years of age.”
Roflumilast cream met all secondary endpoints, with significant improvements seen across all time points including vIGA-AD success and vIGA-AD of ‘clear’ and ‘almost clear’ at Week 1. In the study,
“Atopic dermatitis is a chronic disease that is unstable in its course. EASI-75 has emerged as an important endpoint in clinical trials and reflects clinically meaningful responses in the real world. EASI incorporates body surface area, and higher body surface area involvement is an important consideration for the severity and impact of the disease for patients suffering from pediatric atopic dermatitis,” said Jonathan Silverberg, MD, PhD, MPH, FAAD, Professor, Director of Clinical Research, and Director of Patch Testing at George Washington University School of Medicine and Health Sciences, Washington, DC.
Roflumilast cream was very well-tolerated. Overall, the incidence of adverse events in INTEGUMENT-PED was low, and the only adverse event occurring in ≥
“Roflumilast cream was formulated with the atopic dermatitis patient in mind, delivering drug without disrupting the skin barrier or the use of sensitizing excipients and irritants. The consistent safety and tolerability profile of roflumilast cream sets our next generation PDE4 inhibitor apart,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “In addition, roflumilast cream provided rapid improvement and control in atopic dermatitis as well as quick reduction of itch, which provides the positive feedback loop to the parent and caregiver that the treatment is working and an incentive to maintain therapy over time.”
The Company recently announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream
The Company will host a conference call to discuss the results of both INTEGUMENT-PED and INTEGUMENT-OLE today at 8:30 a.m. ET. A live webcast of the call and the presentation material will be available on the “Events” section of the Company’s investor website. An archived replay of the webcast will be available on the Arcutis investor website following the conference.
About INTEGUMENT-PED
The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (INTEGUMENT-PED) is a Phase 3, parallel group, double blind, vehicle-controlled trial in which 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 phosphodiesterase type 4 (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 is uniquely formulated as a non-greasy emollient cream that absorbs quickly and spreads easily. In addition, roflumilast cream does not include sensitizing excipients or irritants such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances.
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.
ZORYVE is for topical use only and not for ophthalmic, oral, or intervaginal use.
About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early 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 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 X.
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 and timing for roflumilast cream to be approved by the FDA for the treatment of adults and children with atopic dermatitis, the potential to use roflumilast cream over a long period of time, or chronically, the potential to use roflumilast cream anywhere on the body, and the potential for roflumilast cream to advance the standard of care in atopic dermatitis and other 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 the 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. 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:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com
Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com