Arcutis Biotherapeutics, Inc. shared positive results from a Phase 1/2a trial of its investigational drug topical roflumilast cream for the treatment of chronic plaque psoriasis that were published in the August issue of the Journal of Drugs in Dermatology. The results demonstrate that ARQ-151 (roflumilast cream) was safe and highly effective at doses of 0.5% and 0.15%, and represents a potential novel once-daily topical therapy for the treatment of chronic plaque psoriasis.

“Psoriasis imposes a high burden for patients, and current standards of care to treat this skin disease often carry significant treatment limitations, resulting in poor outcomes. Poor outcomes often have a negative impact on patient quality of life,” says Kim A. Papp, MD, PhD, of Probity Medical Research and K. Papp Clinical Research Inc., and lead author of the publication, in a news release.

“Roflumilast once-daily cream demonstrated significant improvements in psoriasis signs and symptoms. Notably, roflumilast cream demonstrated favorable tolerability, without any patient discontinuation due to adverse events. The positive results from this study are encouraging for patients and clinicians who are desperate for a new topical treatment solution that will simplify disease management and improve the patient experience. Enabling patients with more effective chronic treatment in all areas of the body is our hope.”

Roflumilast cream (ARQ-151) is a once-daily, highly potent, selective phosphodiesterase-4 (PDE-4) inhibitor being developed for chronic plaque psoriasis. Arcutis is currently conducting a Phase 3 clinical program with topical roflumilast cream, including two ongoing pivotal Phase 3 clinical trials (DERMIS-1 and -2). The company anticipates topline data from the Phase 3 studies in the first half of 2021.

The Phase 1/2a study assessed the safety and efficacy of once-daily roflumilast cream 0.5% and 0.15% in patients with chronic plaque psoriasis. The study enrolled a single-dose, open-label Phase 1 cohort (0.5% cream applied to 25 cm2 psoriatic plaques), and a 28-day, double-blinded Phase 2a cohort (1:1:1 randomization to roflumilast cream 0.5%, 0.15%, or vehicle). Patients had chronic plaque psoriasis of > 6 months’ duration with ≤5% body surface area involvement. Outcomes included safety (adverse events) and efficacy (percentage change in the product of Target Plaque Severity Score [TPSS] and Target Plaque Area [TPA]) at week 4.

For Cohorts 1 (n=8) and 2 (n=89), adverse events (all mild/moderate; none serious or severe) were similar between active arms and vehicle. Treatment-related events were confined to the application site, with no difference between active and vehicle. No patient discontinued treatment due to adverse events. The primary efficacy endpoint was met for both roflumilast cream doses: TPSS×TPA improvement at week 4 was statistically significant for roflumilast 0.5% (P=0.0007) and 0.15% (P=0.0011) versus vehicle; significance was reached as early as 2 weeks. For both roflumilast cream doses, 66% to 67% improvement from baseline was observed at week 4, without reaching a plateau, versus 38% improvement for vehicle.

“The results from this Phase 1/2a study provide further evidence of the potential of roflumilast cream as a once-daily treatment for patients with plaque psoriasis who currently lack suitable treatment options, and who often have to settle for trade-offs in drug efficacy, safety, and tolerability,” says Frank Watanabe, Arcutis’ President and Chief Executive Officer. “We believe that topical roflumilast has the potential to deliver the efficacy that enables meaningful symptomatic improvement and a safety and tolerability profile that supports chronic use and the ability to use in all body areas.”

Please refer to the paper, “Roflumilast Cream Improves Signs and Symptoms of Plaque Psoriasis: Results from a Phase 1/2a Randomized, Controlled Study” for the full description of the design and results of this study.