August 18, 2022

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Arcutis Biotherapeutics Announces Health Canada Accepts for

  • Submission supported by beneficial clinical details from the pivotal Phase 3 DERMIS-1 and DERMIS-2 scientific reports, as very well as results from prolonged-time period security studies
  • If accredited, roflumilast product would be the initially and only topical PDE4 inhibitor for psoriasis in Canada
  • Concentrate on action day of April 30, 2023
  • Arcutis is in method of establishing Canadian operations

WESTLAKE VILLAGE, Calif., July 11, 2022 (World NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), these days declared that Overall health Canada has accepted for review the New Drug Submission (NDS) for roflumilast cream .3% for the remedy of plaque psoriasis in older people and adolescents. Roflumilast cream (ARQ-151) is a after-each day topical formulation of roflumilast, a highly powerful and selective inhibitor of phosphodiesterase kind 4 (PDE4), an enzyme that drives overactive immune responses. PDE4 is an established focus on in dermatology. The focus on action day is April 30, 2023.

“The acceptance for review of our NDS by Wellness Canada marks an crucial milestone not only for Arcutis but for the around just one million Canadians living with plaque psoriasis who presently have restricted choices when it arrives to topical treatments. Canadian dermatologists and their people have played a important job in our roflumilast clinical growth program with one particular in four individuals in our DERMIS trials enrolled in Canadian web-sites, so we seem forward to furnishing topical roflumilast to them, if permitted,” stated Frank Watanabe, president and CEO of Arcutis. “Arcutis is setting up operations in Canada, and we have begun to make out a solid workforce with deep dermatology and commercialization experience to assist the future acceptance and launch. We appear forward to functioning carefully with Health and fitness Canada during the review method.”

Arcutis’ NDS submission is supported by constructive knowledge from Arcutis’ pivotal Phase 3 plan and two prolonged-term open label reports. DERMIS-1 and DERMIS-2 (“Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two) ended up identical Phase 3 randomized, parallel, double-blind, motor vehicle-managed, multi-nationwide, multi-centre experiments to examine the security and efficacy of roflumilast cream .3%. Somewhere around 1 out of 4 (206/881) patients in DERMIS-1 and DERMIS-2 were enrolled in Canadian websites. Roflumilast fulfilled its principal endpoint and experienced an Investigator Global Assessment (IGA) achievements fee of 42.4% in contrast to a motor vehicle price of 6.1% (P<0.0001), and 37.5% compared to a vehicle rate of 6.9% (P<0.0001), in DERMIS-1 and DERMIS-2, respectively. Roflumilast cream 0.3% also demonstrated statistically significant improvement over vehicle on secondary endpoints, including on 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 with a favorable safety and tolerability profile. The most common adverse reactions include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).

“While topical treatments are the standard therapy for the majority of people with plaque psoriasis, they often come with compromises between efficacy, tolerability, and long-term use,” explained Melinda Gooderham, MSc, MD, FRCPC, Medical Director, SKiN Centre for Dermatology. “If approved in Canada, roflumilast cream has the potential to provide an effective topical treatment option developed as a formulation that can be used for chronic use anywhere on the body, including sensitive areas such as the face, genitals, and intertriginous areas.”

The safety and efficacy of roflumilast cream remain under investigation and market authorization in Canada has not yet been obtained.

A new drug application (NDA) for roflumilast cream for the treatment of plaque psoriasis in adolescents and adults is also under review by the U.S. Food & Drug Administration (FDA). The FDA has set a target action date of July 29, 2022.

Arcutis Canada, Inc., is headquartered in Toronto, Ontario and is led by Jamie Lewis, a highly experienced leader in the Canadian dermatology market, who joined Arcutis in August 2021.

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

Arcutis HealthCanada: Arcutis Biotherapeutics Announces Health Canada Accepts for Review the New Drug Submission

About Roflumilast Cream
Roflumilast cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor, roflumilast. Roflumilast has been approved by the FDA for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. 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 the FDA for the topical treatment of atopic dermatitis or the systemic 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 FDA, one NDS under review with Health Canada, a Phase 3 study completed in seborrheic dermatitis, and two additional Phase 3 clinical data readouts anticipated by end of 2022. The company’s lead program, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn and Twitter.

Forward-Looking Statements

This press release contains “forward-looking” statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care 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.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
[email protected]

Investors
Eric McIntyre, Head of Investor Relations
[email protected]

 

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