Benzinga | Nov 2, 2020 09:04AM EST

Arcutis Biotherapeutics Highlights Presentation Of New Data From Phase 2 Studies Of ARQ-151 In Chronic Plaque Psoriasis, Atopic Dermatitis

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 reported new positive data from previously announced Phase 2 studies of ARQ-151 (topical roflumilast cream) in patients with chronic plaque psoriasis and atopic dermatitis. The data is being presented at the European Academy of Dermatology and Venereology (EADV) Virtual Congress (EADV Virtual), Society of Dermatology Physician Assistants (SPDA) Digital 2020 conference, and virtual 2020 Fall Clinical Dermatology Conference.

Roflumilast cream, a potent phosphodiesterase-4 (PDE-4) inhibitor, is being investigated as a once-daily topical treatment for chronic plaque psoriasis and atopic dermatitis. In two virtual presentations, Arcutis shared data from a Phase 2b study on the efficacy of roflumilast cream on itch, a highly prevalent and frequently bothersome symptom of chronic plaque psoriasis, and on improving the burden of typical plaque psoriasis symptoms. In a third presentation, Arcutis highlighted results from a Phase 2 proof-of-concept study on the short-term safety and efficacy of roflumilast cream in patients with mild-to-moderate atopic dermatitis.

"The results from our Phase 2 studies highlight the potential of roflumilast cream as a best-in-class topical PDE4 inhibitor for chronic plaque psoriasis and atopic dermatitis," said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis' Chief Medical Officer. "The Phase 2b psoriasis study data provide clinical evidence of roflumilast cream's ability to reduce the burden of itch and improve typical symptoms in patients with plaque psoriasis. In addition, the encouraging efficacy results and safety profile in our Phase 2 proof-of-concept of roflumilast cream in atopic dermatitis provide a solid foundation for our upcoming pivotal Phase 3 studies."

Results from the Phase 2b Study in Plaque Psoriasis

In the Phase 2b study, 331 patients were randomized to roflumilast 0.3% (n=109), roflumilast 0.15% (n=113), or vehicle (n=109). At baseline, patients had to score ?2 on the Investigator Global Assessment (IGA) scale and ?2 on the modified Psoriasis Area and Severity Index. The primary endpoint was achievement of clear or almost clear skin based on IGA 0 or 1 at Week 6.

Itch was assessed at baseline and throughout the 12-week trial using various patient-reported outcome measures, including itch severity and itch-related sleep loss. The study showed that treatment with roflumilast cream resulted in a rapid and clinically significant reduction in the severity and burden of itch compared to vehicle. In the roflumilast 0.3% group, significant itch reduction occurred by week 2 as compared with vehicle and continued through week 12 with 63% of patients achieving a clinically meaningful itch reduction. Reduction in itch also resulted in significant improvement in sleep loss by week 6 and continued through week 12.

The Phase 2b study also assessed the efficacy of roflumilast cream in improving the burden of signs and symptoms of plaque psoriasis, including stinging, burning, skin cracking, pain, and scaling. Both doses of once-daily roflumilast cream led to rapid and robust improvements in symptom burden and quality of life in the patient population. The study results showed statistically significant improvements for both roflumilast doses compared with vehicle were seen in burden of individual patient-reported psoriasis-related signs and symptoms of scaling by Week 2; stinging, skin cracking, and pain by Week 4; and burning by Week 6. All reported improvements in individual psoriasis-related signs and symptoms were maintained through Week 12 with a mean decrease from baseline in the overall Patient Symptom Diary (PSD) Score of 42 and 44 in the roflumilast 0.3% and 0.15% groups, respectively.

Roflumilast cream was well-tolerated by patients in the Phase 2b study. The rate of application site pain was low and similar to vehicle. 97% of adverse events were mild or moderate.

Results from the Phase 2 Proof-of-Concept Study in Atopic Dermatitis

In the Phase 2 proof-of-concept study in atopic dermatitis (AD), 136 patients were randomized to roflumilast 0.15%, roflumilast 0.05% or vehicle once-daily for 4 weeks. Patients had 1.5--35% body surface area (BSA) affected by AD, with a validated investigator global assessment AD (vIGA-AD) score of 2 (mild) or 3 (moderate), and eczema area and severity index (EASI) score of ?5. The primary efficacy endpoint was absolute change from baseline in EASI score at Week 4.

Study results showed that once-daily roflumilast cream demonstrated efficacy when compared to vehicle in AD. Although the primary endpoint in this proof of concept study showed a trend towards, but did not reach statistical significance, statistical significance for other efficacy endpoints was reached. Statistically significant improvements compared with vehicle were observed at Week 4, including 72.3% EASI improvement and >50% of patients achieving clear or almost clear skin on vIGA-AD for roflumilast cream 0.15%. Roflumilast cream was well tolerated, with a low rate of application site reactions, and no local irritation.

The virtual presentations of Arcutis' Phase 2b and Phase 2 proof-of-concept studies of roflumilast cream given at the EADV Virtual Congress (October 29-31, 2020) and the 2020 Fall Clinical Dermatology Conference and SPDA DIGITAL 2020 (October 29 -- November 1, 2020), are available for on-demand viewing using the links below and under Scientific Publications on the Arcutis website:

* Roflumilast Cream (ARQ-151) Improved Itch Severity and Itch-related Sleep Loss in Adults With Chronic Plaque Psoriasis in a Phase 2b Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020

* Roflumilast Cream (ARQ-151) 0.15% and 0.3% Improved Symptom Burden in Adults With Chronic Plaque Psoriasis in a Phase 2b Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020

* The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis: Phase 2 Proof-of-Concept Study: EADV Virtual Congress; 2020 Fall Clinical; SPDA DIGITAL 2020