TORONTO, ON, January 8, 2024 — Arcutis Canada Inc., an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, is pleased to announce that Health Canada has accepted for review the Supplement to a New Drug Submission (SNDS) for roflumilast foam 0.3%, a steroid-free, once-daily phosphodiesterase-4 (PDE4) inhibitor for the topical treatment of seborrheic dermatitis in adult and adolescent patients 9 years of age and older.
Seborrheic dermatitis is a chronic condition that requires long-term disease management. There is a particular need for new steroid-free treatment options to help address current treatment challenges regarding efficacy, safety, and tolerability. If approved, roflumilast foam 0.3% would be the first topical drug with a new mechanism of action approved in Canada for seborrheic dermatitis in over two decades1.
“Seborrheic dermatitis is one of the most common chronic inflammatory skin conditions I see in my practice and can be challenging to treat, especially in hair-bearing areas of the body such as the scalp and sensitive areas such as the face. New treatment options could improve the experience of patients who often face social stigma because the symptoms like flaking and redness are so visible to others,” said Dr. Irina Turchin, MD, FRCPC, dermatologist and principal Canadian investigator in the STRATUM pivotal Phase 3 trial. “The results from the Phase 3 pivotal trial of roflumilast foam documented itch relief at 48 hours and showed improvements in control of visible symptoms in as early as two weeks; critical measures for people who live with seborrheic dermatitis. Long-term data show clinical efficacy was maintained for up to 52 weeks with no new safety signals observed, giving roflumilast foam the potential to be an important steroid-free topical option for the long-term management of seborrheic dermatitis.”
Seborrheic dermatitis is a skin condition that is estimated to affect approximately 5% of the global population, a prevalence rate that is likely underestimated due to lack of disease recognition and diagnosis2. It is more common in males than in females, and presents itself in infancy, adolescence, and young adulthood or in adults over 50 years of age2. Seborrheic dermatitis typically occurs in areas of the body with oil-producing (sebaceous) glands, such as the scalp, face, ears, chest, back, and groin2.
“Health Canada’s acceptance for review of the SNDS for roflumilast foam marks another exciting milestone for topical roflumilast in our journey to advance the treatment of immune-mediated skin diseases and support unmet medical needs,” said Jamie Lewis, head of Arcutis Canadian operations. “We are thankful for the investigators and patients who participated in clinical trials across Canada and look forward to continuing our collaboration with Health Canada on its review of roflumilast foam and the potential to evolve the treatment landscape for seborrheic dermatitis.”
The acceptance by Health Canada for review of roflumilast foam 0.3% is 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.
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 ZORYVE™ foam reported a 28% improvement in itch from baseline in 48 hours (compared to 13% on vehicle nominal; P=0.0024).
In all 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 (0.7% and 2.0% in the roflumilast foam and vehicle groups, respectively). Overall, the most common adverse events in the STRATUM study population included COVID-19, urinary tract infection, nasopharyngitis, and nausea.
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 foam is a once-daily foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.
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. 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.
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 or follow Arcutis on LinkedIn, Facebook, and X.
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 potential for roflumilast foam to be approved by Health 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 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 28, 2023, 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.
Amanda Sheldon, Head of Corporate Communications
Investor Relations Advisory Solutions
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