If approved, roflumilast cream 0.05% — a topical phosphodiesterase-4 (PDE4) inhibitor—would offer Canadian children with AD as young as 2 years old, a new, once daily steroid-free treatment option, designed with the unique needs of young children with atopic dermatitis in mind.

The SNDS is supported by data from Arcutis’ pivotal Phase 3 INTEGUMENT-PED trial, its long-term extension study, INTEGUMENT-OLE, and a phase 1 pharmacokinetic study. In the Phase 3 trial, roflumilast cream 0.05% demonstrated statistically significant improvements in disease clearance and itch reduction compared to vehicle, with meaningful improvements observed as early as Week 1. Safety and tolerability results with roflumilast cream 0.05% were consistent with what has been observed in older groups with mild to moderate AD treated with roflumilast cream 0.15%.

Key findings from the INTEGUMENT-PED trial include:

• Efficacy Outcomes: At Week 4, 25.4% of children treated with roflumilast cream 0.05% achieved vIGA-AD Success—defined as a validated Investigator Global Assessment–Atopic Dermatitis (vIGA-AD) score of clear or almost clear with a ≥2-grade improvement—compared to 10.7% with vehicle (p<0.0001). Significant improvements were observed as early as Week 1.
• Eczema Area and Severity Index (EASI) Improvement: At Week 4, the key secondary endpoint of EASI-75 (≥75% improvement from baseline) was achieved by 39.4% of children treated with roflumilast cream 0.05% compared to 20.6% with vehicle (p<0.0001).
• Safety and Tolerability: Roflumilast cream 0.05% was generally well tolerated, with a low incidence of adverse events and a safety profile consistent with older children and adults treated with roflumilast cream 0.15% for mild to moderate AD.

Long-term outcomes: Results from the INTEGUMENT-OLE extension study showed that efficacy was maintained with continued use and the safety profile remained consistent over one year. This reinforces the potential role of roflumilast cream 0.05% in supporting children who may need ongoing management for AD.

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 0.05% is formulated with HydroARQ Technology^™ as a non-greasy emollient cream that is designed to absorb quickly and spread evenly. The formulation has a physiological skin pH and excludes common sensitizing excipients and irritants, including propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, and fragrances.

Roflumilast cream 0.15% (^PrZORYVE^®) is approved by Health Canada for the topical treatment of mild to moderate atopic dermatitis (AD) in patients 6 years of age and older.

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

Health Canada has authorized the use of roflumilast foam 0.3% (ZORYVE) for the topical treatment of seborrheic dermatitis in patients 9 years of age and older.

For more information about roflumilast cream 0.15%, roflumilast cream 0.3% and roflumilast foam 0.3%, including prescribing and safety information, please consult the ZORYVE Canadian product monograph here.

Roflumilast foam 0.3% is under review by Health Canada for the topical treatment of scalp and body psoriasis in patients aged 12 years and older, supported by data from Arcutis’ pivotal Phase 3 trial, a Phase 2b study, and long-term efficacy and safety data generated from the ZORYVE cream development program in plaque psoriasis.

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 of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.ca.

Forward-Looking Statements

Arcutis cautions you that statements contained in this media alert 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 approval and availability of ZORYVE cream 0.05% in Canada, the potential of real-world use results of ZORYVE cream in AD in children aged 2 to 5, and the potential for ZORYVE cream to advance the standard of care in AD 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.

Contacts

Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

References

1. Gooderham M.J., Hong C-H., Lynde C., et al. Canadian Consensus Guidelines for the Management of Atopic Dermatitis with Topical Therapies. Dermatology and Therapy. Read more.
2. Canadian Dermatology Association. Types of Eczema – Atopic Dermatitis.
3. Bridgman A.C., et al. The Burden of Moderate to Severe Atopic Dermatitis in Canadian Children: A Cross-Sectional Survey. J Cutan Med Surg. 2018;22(3):290-297. Available here.
4. Canadian Skin Patient Alliance. Atopic Dermatitis (Eczema).