Arcutis Biotherapeutics Inc. (ARQT) Showcases New Roflumilast Data in Psoriasis and Seborrheic Dermatitis at American Academy of Dermatology

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced the presentation of new data demonstrating the safety and efficacy of roflumilast foam for the treatment of scalp and body psoriasis in a late-breaking oral presentation at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) held on April 23-25, 2021.

The company is also showcasing data from four additional posters during the meeting, including a presentation on the safety and efficacy of roflumilast foam in the treatment of seborrheic dermatitis and three posters related to roflumilast cream in mild-to-severe chronic plaque psoriasis, including its impact on itch and use for steroid-sensitive areas. Roflumilast cream and foam are investigational once-daily, topical formulations of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.

“Psoriasis and seborrheic dermatitis can significantly impact quality of life and are very challenging to treat, particularly long-term,” said Patrick Burnett, M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis. “These new data add to the growing body of evidence supporting the potential of roflumilast, if approved, as an important, new treatment option for people affected by these chronic dermatological conditions.”

New findings from the late-breaking presentation demonstrate that roflumilast foam significantly improved both scalp and body psoriasis, with improvement as early as two weeks after treatment initiation. The primary endpoint of Scalp Investigator’s Global Assessment (S-IGA) success (clear/almost clear and ≥2-grade reduction from baseline) at week eight was achieved by 59.1% of patients receiving roflumilast foam versus 11.4% of patients receiving vehicle (P<0.0001), with 34.3% of roflumilast foam-treated and 3.4% of vehicle-treated patients rated clear at week eight. Body IGA success at week eight was achieved by 40.3% and 6.8% of patients receiving roflumilast foam and vehicle, respectively (P<0.0001).Roflumilast foam was well-tolerated in the study. The incidence of treatment-related adverse events (TEAEs), application site adverse events (AEs), and discontinuations due to AEs were low and similar to vehicle. The most common TEAEs were application site pain (1.0% vs. 3.8%), diarrhea (1.5% vs. 0%), COVID-19 (1.5% vs. 1.9%), sinusitis (0.5% vs. 1.9%), psoriasis (0.5% vs. 1.9%), and hypertension (1.5% vs. 1.0%) for roflumilast foam and vehicle, respectively. Discontinuation due to AEs was 2.5% for roflumilast foam and 1.9% for vehicle. In the study, no patients in either group experienced any serious AEs.“Many current treatment options for psoriasis often carry significant limitations, particularly when being used to treat body areas covered with hair, which result in poor outcomes and additional patient burden,” said lead investigator Leon Kircik, M.D., Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, Indiana University Medical Center, and Medical Director, Physicians Skin Care, DermResearch, and Skin Sciences, Louisville, KY. “Roflumilast once-daily foam, a novel formulation specifically designed for use on hair-bearing areas of the body like the scalp, but usable on all areas of the body, demonstrated significant benefit on both scalp and non-scalp areas. These positive results are encouraging for patients and clinicians who are desperate for new treatments that can simplify disease management, be used in all areas of the body, and ultimately improve the patient experience.” Key findings from the other roflumilast foam and cream presentations include:

• Efficacy and Safety of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis in a Randomized, Double-blind, Vehicle-controlled Phase 2 Study
  • Findings from this Phase 2 study demonstrated roflumilast foam is a safe, well-tolerated, and effective treatment in patients with seborrheic dermatitis. Treatment with roflumilast foam led to significant improvement in IGA Success, as well as erythema and scaling individually, and symptomatic improvement in itch in patients. Improvements in IGA Success were statistically significant at the first post-baseline visit at week two and continued through week eight. Rates of treatment-related AEs, discontinuations due to AEs, and application-site pain were low and similar to vehicle.
• Correlation of Itch Response to Roflumilast Cream with Disease Severity and Patient-Reported Outcomes in Patients with Chronic Plaque Psoriasis
  • The Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey showed that the top factor contributing to disease severity in psoriasis according to patients was itch, but according to physicians, it was location/size of lesions. Consistent with these findings, the baseline data from this Phase 2b study in patients with chronic plaque psoriasis demonstrated that patient-reported itch was not always consistent with physician-assessed disease severity and that patients with mild disease can still experience considerable itch. In this Phase 2b study, treatment with roflumilast cream resulted in rapid and robust improvement in the severity of itch, itch-related sleep loss, and quality of life in patients with chronic plaque psoriasis.
• Roflumilast Cream Significantly Improves Chronic Plaque Psoriasis in Patients with Steroid-Sensitive Area Involvement
  • Many patients with psoriasis have plaques on difficult to treat areas such as the face or intertriginous regions. Topical corticosteroids and vitamin D derivatives must be used with caution in these areas because they can cause side effects or tolerability problems, especially with long-term use. In this Phase 2b study, roflumilast cream was well-tolerated and provided significant improvements in investigator and patient‑assessed outcomes in participants with steroid-sensitive area involvement in a post-hoc analysis of the face, neck, or intertriginous areas in patients with chronic plaque psoriasis.
• The PASI-HD Improved Precision in Measuring Disease Severity in Subjects with Mild-to-Moderate Plaque Psoriasis Treated with Roflumilast Cream, a PDE4 Inhibitor
  • The Psoriasis Area and Severity Index (PASI) is the gold standard measure in psoriasis clinical trials, but lacks sensitivity where the affected area is <10% body surface area. Most patients with chronic plaque psoriasis have mild-to-moderate disease, thus a higher level of discrimination for the assessment of disease severity is needed. PASI-HD is proposed as a modification to PASI to provide higher discrimination of the effects of treatment in areas with <10% involvement. This post-hoc analysis of the Phase 2b study of roflumilast cream in patients with mild-to-moderate plaque psoriasis, demonstrated that PASI-HD is more precise as compared to PASI for scoring disease severity in areas of disease involvement <10%.

For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter. Join the conversation with the hashtag #AADVMX2021.

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