ARQT Arcutis Biotherapeutics Inc

• Once-daily, steroid-free foam designed to treat seborrheic dermatitis on all affected areas of the body, including hair-bearing regions such as the scalp
• Clinical trial data show notable improvement in signs and symptoms, with the majority of patients experiencing reduced itching, scaling and redness, common burdens associated with seborrheic dermatitis¹
• ZORYVE foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved in Canada in over 20 years²

TORONTO, Oct. 21, 2024 /CNW/ - Arcutis Canada Inc., a commercial-stage company focused on delivering meaningful innovations in immuno-dermatology, is pleased to announce that Health Canada has approved ZORYVE^® (roflumilast foam 0.3%), for the treatment of seborrheic dermatitis in patients 9 years of age and older. Health Canada's approval of this steroid-free, once-daily phosphodiesterase-4 (PDE4) inhibitor brings a novel approach to the management of seborrheic dermatitis, offering a new once-daily treatment option for this chronic skin condition.

Seborrheic dermatitis is a chronic, recurrent inflammatory skin condition that requires ongoing disease management, and causes physical discomfort and visible symptoms that can interfere with daily activities and impose an emotional burden on affected individuals.² As the first topical treatment for seborrheic dermatitis with a novel mechanism of action approved in Canada in over 20 years², ZORYVE foam can be used on all affected areas of the body, including hair-bearing areas such as the scalp, with no limitation on duration of use. 

"The challenges in managing seborrheic dermatitis have long been felt by both clinicians and patients. There has been a need to strike the right balance in a treatment that can achieve both disease clearance and symptom relief and also support adherence," said Dr. Melinda Gooderham, medical director at the SKiN Centre for Dermatology and a principal Canadian investigator in the pivotal Phase 3 STRATUM trial. "The approval of ZORYVE foam by Health Canada is a significant development in the management of this condition. Clinical trial data show close to 80% of patients achieving treatment success at week 8 and rapid itch relief in as little as 48 hours. Feedback from trial patients has been overwhelmingly positive and I look forward to offering ZORYVE foam as a steroid-free, once-a-day option that has the potential to simplify the management of seborrheic dermatitis."

Seborrheic dermatitis causes red patches covered with oily, flaking yellow scales and can affect the scalp, face, ears, chest, and groin. The most common and burdensome symptom is itch.³ Its chronic nature and high visibility can significantly burden patients and impact self-esteem, social interactions, and overall quality of life.² Seborrheic dermatitis typically manifests in adolescence,  adulthood, or in adults over the age of 50.³ Approximately 2 million Canadians are impacted by the condition.^3,4

"The approval of ZORYVE foam by Health Canada marks an important moment in the management of seborrheic dermatitis. We are proud to be the first company in more than two decades to introduce a non-steroidal treatment designed to address key challenges in disease management and support improvement in overall patient outcomes," said Frank Watanabe, president and CEO of Arcutis. "This milestone underscores our commitment to advancing treatment options for immune-mediated skin diseases and we are confident this new therapy will make a meaningful difference for Canadian patients and healthcare providers."

"We are grateful to the Canadian dermatology community for their ongoing partnership with Arcutis and continued commitment to embracing and advancing innovation for dermatological conditions. We extend our sincere gratitude to the clinicians and patients who participated in the trials, as well as to our dedicated team whose efforts made this achievement possible," said Jamie Lewis, vice president and general manager, Arcutis Canada, Inc. "We anticipate that ZORYVE foam will contribute to meeting the ongoing need for effective and convenient treatment options, and we look forward to bringing this innovative therapy to the Canadian market by the end of the year."

Health Canada approval of ZORYVE foam is based on Phase 2 and pivotal Phase 3 trial results. The foam formulation is also approved in the United States, supported by the same safety and efficacy data.

ZORYVE Foam Clinical Data

Roflumilast foam 0.3% was evaluated in a comprehensive clinical program, including Phase 2 and Phase 3 trials. For more information about ZORYVE foam, including prescribing and safety information please consult the Canadian product monograph here.

The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was the pivotal Phase 3, parallel group, double-blind, vehicle-controlled study evaluating the safety and efficacy of roflumilast foam 0.3% in individuals ages 9 and older with moderate to severe seborrheic dermatitis. The STRATUM study met its primary endpoint with an Investigator Global Assessment (IGA) Success rate of 79.5% in roflumilast foam-treated individuals compared to 58.0% (P<0.0001) in those treated with vehicle at Week 8. IGA Success was defined as an IGA score of clear or almost clear plus a ≥2 grade improvement from baseline. Improvement with roflumilast foam was seen early, with roflumilast demonstrating a statistically significant improvement compared to vehicle on IGA Success at Week 2, the first timepoint assessed. In addition, 50.6% of individuals in the roflumilast foam treated arm reached complete clearance, defined as an IGA score of 0, at Week 8 (27.7% for vehicle; P<0.0001).

The study also demonstrated statistically significant improvement over vehicle on all secondary endpoints, including itch, scaling, and erythema (redness). More than 60% of individuals achieved an itch response at Week 8 (62.8% roflumilast foam vs 40.6% vehicle; P=0.0001), and significant improvements in itch were reported at Week 2 and Week 4. Individuals treated with roflumilast foam reported a 28% improvement in itch from baseline in 48 hours (compared to 13% on vehicle; nominal P=0.0024).

In both the Phase 2 and Phase 3 trials, roflumilast foam was generally well-tolerated. Incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events (SAEs). Over 90% of patients who were randomized to roflumilast foam in the study completed the full eight weeks, and there were few discontinuations due to adverse events (0.9% and 2.2% in the roflumilast foam and vehicle groups, respectively). Overall, the most common adverse events in the study population included nasopharyngitis, nausea, and headache.

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 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 cream 0.15% is under review by Health Canada for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older, supported by clinical results from Arcutis' Phase 2 and pivotal Phase 3 trials in AD.

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, 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, but are not limited to, statements regarding the availability of roflumilast foam in Canada for the treatment of adults and adolescents with seborrheic dermatitis, the potential for roflumilast foam to enhance available options for seborrheic dermatitis, the potential to use roflumilast foam anywhere on the body, including the face and scalp, the potential treatment results from real world clinical practice, the potential to use roflumilast foam over a long period of time, or chronically, and the potential for roflumilast foam to advance the standard of care in seborrheic 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.