TORONTO, May 28, 2024 /CNW/ – Arcutis Canada, Inc., a commercial-stage company focused on developing meaningful innovations in immuno- dermatology, announced today that Health Canada has accepted for review its Supplement to a New Drug Submission (SNDS) for roflumilast cream 0.15%, for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older.

If approved, this once-daily topical cream formulation of roflumilast would offer an effective, fast acting and well-tolerated novel steroid-free treatment option to manage AD.

Atopic dermatitis, the most prevalent form of eczema, is a chronic and relapsing inflammatory skin condition characterized by intensely itchy and inflamed skin that can occur anywhere on the body and may present differently in infants, children and adults. The variability and relapsing nature of atopic dermatitis underscore the importance of effective management options for atopic dermatitis across all age groups to obtain and maintain disease control without rotational therapy and “chasing flares”.

“The INTEGUMENT studies have demonstrated the excellent efficacy and tolerability of roflumilast cream 0.15% in both adults and children, which is particularly important given the need for patients to have more non-steroidal topical options for the management of atopic dermatitis,” said Dr. Melinda Gooderham, Medical Director at the SKiN Centre for Dermatology and a principal Canadian investigator in the Phase 3 pivotal INTEGUMENT trials. “Trial data showed when applied once daily, roflumilast cream was effective at improving AD over multiple endpoints, rapidly improving symptoms and alleviating itch, a particularly distressing symptom for patients, within as little as 24 hours. The promising combination of efficacy and tolerability shown in the pivotal trials along with the favourable long term safety profile suggest that if approved, roflumilast cream has the potential to improve patient adherence and elevate the management of atopic dermatitis with an option that aligns with patient preferences and concerns.”

In addition to controlling itch and suppressing inflammation, addressing skin barrier disruption is

an essential aspect of managing AD. Roflumilast cream 0.15% is uniquely formulated with HydroARQ Technology™ as a non-greasy emollient cream designed to absorb quickly and spread easily without disrupting the skin barrier, which is crucial for maintaining skin health in individuals with AD. It is formulated at physiological skin pH and is free of sensitizing excipients and irritants, such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances that have the potential to aggravate skin sensitivity and trigger reaction.

“Atopic dermatitis patients face unique challenges including significant problems with skin inflammation and sensitive skin. Treatment strategies which consider the importance of the skin barrier can help to improve symptoms and reduce the frequency of flare-ups. For most patients, topical treatment remains the cornerstone of therapy. Roflumilast cream 0.15% is emerging as a promising advancement developed with the needs of atopic dermatitis patients in mind since it is formulated without ingredients that could compromise the skin barrier and without common contact allergens,” said Dr. Chih-ho Hong, a principal investigator for the INTEGUMENT trials in Canada.

“Today’s announcement represents another noteworthy milestone for Arcutis Canada, as the third topical roflumilast submission to Health Canada. We are committed to delivering on our promise to Canadians by introducing meaningful advances that address their needs. Collaborating closely with the medical community provides us valuable insights into patient experiences and how the treatments we bring to market can effectively overcome current limitations,” said Jamie Lewis, Vice President and General Manager, Arcutis Canada, Inc. “I want to express my sincere gratitude to the patients who participated in the studies, the dedicated investigators collaborating with us to deliver innovative solutions and the exceptional team at Arcutis who have made this achievement possible.”

The SNDS includes data from the “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis” (INTEGUMENT-1 and INTEGUMENT-2) trials, two identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once-daily for four weeks to individuals 6 years of age and older with mild to moderate AD involving ≥3% body surface area.

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: 32.0% roflumilast cream vs. 15.2% vehicle, P<0.0001; INTEGUMENT-2: 28.9% roflumilast cream vs. 12.0% vehicle, P<0.0001).

Over 30% of individuals treated with roflumilast cream in each study achieved Worst Itch-Numeric Rating Scale (WI-NRS) Success at Week 4. WI-NRS Success is defined as achievement of at least a 4-point reduction on the WI-NRS 0 (no itch) to 10 (worst imaginable itch) scale (in individuals 12 and older who had a baseline WI-NRS score of at least 4). Rapid and significant improvement in itch was observed in individuals treated with roflumilast cream 0.15% compared with vehicle as early as 24 hours following the first application, as measured by the least-squares (LS) mean change from baseline in daily WI-NRS scores between the two groups (nominal P<0.05).

In both studies, approximately 40% of children and adults treated with roflumilast cream 0.15% achieved a vIGA-AD score of Clear (0) or Almost Clear (1) at Week 4 (INTEGUMENT-1: 41.5% vs. 25.2%, P<0.0001; INTEGUMENT-2: 39% vs. 16.9%, P<0.0001), with significant improvement as early as Week 1 (P< 0.0001).

In addition, more than 40% of children and adults treated with roflumilast cream 0.15% achieved a 75% reduction in Eczema Area and Severity Index (EASI-75) at Week 4 compared to vehicle (INTEGUMENT-1: 43.2% vs. 22.0%, P<0.0001; INTEGUMENT-2: 42.0% vs. 19.7%, P<0.0001). Significant improvements in EASI-75 were observed with roflumilast cream 0.15% as early as Week 1 in both studies (nominal P=0.0006; nominal P=0.0329).

Roflumilast cream 0.15% was generally well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low in both active treatment and vehicle arms, with most TEAEs assessed as mild to moderate in severity. There were no adverse reactions in the combined Phase 3 pivotal trials that occurred in more than 2.9% of subjects in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). 

The Health Canada submission is also supported by data from a Phase 2 dose ranging study, an open label extension study in which patients were treated for up to 52 weeks, and two Phase 1 pharmacokinetic studies.

About Topical Roflumilast

Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective PDE4 inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. 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 0.3% (^PrZORYVE®) is approved in Canada for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. In the United States, the same indication was recently expanded for use in patients 6 years of age and older.

For more information about roflumilast cream 0.3%, including prescribing and safety information, please consult the ZORYVE Canadian product monograph here.

Roflumilast foam is a once-daily foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis. Roflumilast foam 0.3% is under review by Health Canada for the topical treatment of seborrheic dermatitis in adult and adolescent patients 9 years of age and older, supported by clinical results from Arcutis’ Phase 2 and pivotal Phase 3 trials in seborrheic dermatitis. Roflumilast foam 0.3% was approved for the treatment of seborrheic dermatitis in individuals aged 9 years and older by the U.S. Food and Drug Administration (FDA) in December 2023 based on analysis of safety and efficacy data from these trials.

About Atopic Dermatitis

Atopic dermatitis (AD) is a genetically pre-disposed skin condition that often starts in childhood but can affect individuals of any age. Hallmark symptoms of AD include itching as well as dry skin (xerosis) impacting both affected (lesional) and unaffected (non-lesional) skin. AD is associated with profound impacts on the quality of life of both affected individuals and their caregivers, including high rates of sleep disturbance and increased risk for mental health disorders. An estimated 17% of Canadians will experience the condition at some stage in their lifeⁱ.

About Arcutis

Arcutis Canada, Inc. is a subsidiary of Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), 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.ca.

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 cream to be approved by Health Canada for the treatment of adults and children with atopic dermatitis, the potential for roflumilast cream to enhance available options for atopic dermatitis, the potential of real-world use results of roflumilast cream, 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 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.

SOURCE Arcutis Canada Inc.

For further information: Media: Amanda Sheldon, Head of Corporate Communications, asheldon@arcutis.com; Investors: Latha Vairavan, Vice President, Finance and Investor Relations, lvairavan@arcutis.com