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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

  • 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 cream 0.05% achieved Investigator Global Assessment (IGA) Success compared to 10.7% 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 cream 0.05% achieved a 75% 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 0.05%, in children ages 2 to 5 years with mild to moderate atopic dermatitis (AD) met its primary endpoint and all secondary endpoints. In the study, 25.4% of children treated with roflumilast cream 0.05% achieved 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, compared to 10.7% treated with vehicle (P<0.0001), with significant improvements seen as early as Week 1.

Roflumilast cream 0.05% is a once-daily steroid-free topical cream in development, that is formulated to deliver drug without disrupting the skin barrier. INTEGUMENT-PED enrolled 652 children ages 2 to 5, with a mean Body Surface Area (BSA) of 22% overall, and a range from 3% to 82%. The data reinforce the well-established efficacy, safety and tolerability profile of roflumilast cream in atopic dermatitis across the INTEGUMENT program.

“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, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI-75 at Week 4 compared to 20.6% treated with vehicle (P<0.0001). In addition, 35.3% of children treated with roflumilast cream achieved a four-point reduction in Worst Itch Numeric Scale (WI-NRS) at Week 4 (vs. 18.0% for vehicle-treated subjects [nominal P=0.0002]).

“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 ≥3% of subjects in either arm was upper respiratory tract infection. The most frequent adverse events in the roflumilast arm (≥2%) included upper respiratory tract infection, pyrexia, diarrhea, and vomiting. Of children who were randomized to roflumilast cream in the study, 93.8% completed the full four weeks, and there were few discontinuations due to adverse events (1.1% and 1.9% in the roflumilast cream and vehicle groups, respectively). Of the children who completed INTEGUMENT-PED, 93.4% elected to continue open label, long-term treatment in the INTEGUMENT-OLE study.

“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 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children ages 6 years and older. Following the potential approval of roflumilast cream 0.15% and based on these positive results, Arcutis intends to submit an sNDA for roflumilast cream 0.05% for the treatment of mild to moderate atopic dermatitis in children ages 2 to 5 years.

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.

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 0.05% or vehicle was applied once daily for four weeks to children 2 to 5 years of age with mild to moderate AD. A total of 652 children were enrolled in the study. The primary endpoint was IGA Success, defined as a vIGA-AD score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4. Multiple secondary endpoints were also evaluated, including the proportion of subjects who attain at least a 75% reduction in the EASI-75 at Week 4.

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 0.3% (ZORYVE®) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Roflumilast cream for AD was evaluated at lower doses: 0.15% for adults and children 6 years of age and older and is being evaluated at 0.05% for children aged 2 to 5 years.

ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

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.

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 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.

Amanda Sheldon, Head of Corporate Communications

Eric McIntyre, Head of Investor Relations

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