Arcutis Biotherapeutics Reaches Regulatory Milestone with Health Canada Acceptance of New Drug Submission for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis

• Submission supported by efficacy data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as well as results from long-term safety studies
• Arcutis has established Canadian operations as company expands to key markets  

TORONTO, July 11, 2022 /CNW/ - Arcutis Canada Inc., a medical dermatology company and subsidiary of Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), announced today that Health Canada has accepted the New Drug Submission (NDS) for roflumilast cream 0.3% (ARQ-151) for the treatment of plaque psoriasis in adults and adolescents. The safety and efficacy of roflumilast cream remain under investigation, and market authorization in Canada has not yet been obtained.

Roflumilast cream is a once-daily topical formulation of roflumilast, an inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses and is an established target in dermatology.

One million Canadians suffer from psoriasis, a chronic inflammatory skin conditionⁱ. Plaque psoriasis, the most common form, affects approximately 90% of people who have the condition, and appears as raised, scaly, red patches or plaques that can form anywhere on the body and can also be itchy and painfulⁱ. If approved by Health Canada, roflumilast will be an important new treatment option for people suffering from psoriasis.

"This is a major milestone for Arcutis in Canada and an important step towards potentially bringing an alternative topical option to market for plaque psoriasis that has been developed for chronic use anywhere on the body, including sensitive areas such as the face, genitals and in areas where the skin rubs together," said Jamie Lewis, Head of Arcutis Canadian operations. "We are building a strong presence in Canada and look forward to working together with Health Canada and the dermatology community on behalf of Canadian patients."

Founded in 2016, Arcutis Biotherapeutics is focused on delivering meaningful innovation to address the most persistent challenges for individuals with immune-mediated skin diseases such as plaque psoriasis. The company has brought together an internal team of experts with deep dermatology experience to drive the development of its products and further expand its development program to address unmet needs in dermatology.

The Arcutis NDS is supported by clinical trial results from Arcutis' pivotal Phase 3 program and two long-term open label studies. DERMIS 1 and DERMIS 2 (Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS" One and Two) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-centre studies to evaluate the safety and efficacy of roflumilast cream 0.3%. Approximately one out of four (206 of 881) patients in DERMIS-1 and DERMIS-2 were enrolled in Canadian sites. In its Phase 3 trials, roflumilast met its primary endpoint evaluating Investigator Global Assessment (IGA) success rate vs. vehicle-treated patients. Roflumilast cream 0.3% also demonstrated statistically significant improvement over vehicle on key secondary endpoints, including Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). Efficacy results for patients continuing treatment with roflumilast cream in open–label extension studies of 6– and 12–month duration were maintained throughout treatment. In all trials, roflumilast cream was generally well-tolerated.

About Roflumilast Cream

Roflumilast cream is a topical cream formulation of a PDE4 inhibitor, roflumilast. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by regulatory authorities for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis. If approved, roflumilast cream would be the first topical PDE4 inhibitor specifically for the treatment of plaque psoriasis.

About Arcutis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis 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, with one NDA submission now under review with the US FDA and one NDS under review with Health Canada and three Phase 3 clinical data readouts anticipated over the next 18 months. Please visit the investors page of the Arcutis US website (https://investors.arcutis.com/) for information on Arcutis securities.

Forward-Looking Statements

This press release contains "forward-looking" statements, including, among others, statements regarding the potential of roflumilast in plaque psoriasis and other inflammatory dermatological conditions. These statements involve 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 and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property.  For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 22, 2022, as amended on March 3, 2022, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

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ⁱ Canadian Dermatology Association; Psoriasis; Available at:  https://dermatology.ca/public-patients/skin/psoriasis/; Last accessed July 4, 2022.

SOURCE Arcutis Canada Inc.

Media: Amanda Sheldon, Head of Corporate Communications, [email protected]; Investors: Eric McIntyre, Head of Investor Relations, [email protected]