Topical roflumilast cream shows promise against psoriasis

WESTLAKE VILLAGE, Calif.—Arcutis Biotherapeutics Inc., a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, has announced that The Journal of Drugs in Dermatology published positive results in its August 2020 issue from a Phase 1/2a trial of its investigational drug topical roflumilast cream for the treatment of chronic plaque psoriasis.

The results reportedly demonstrate that ARQ-151 (roflumilast cream) was safe and highly effective at doses of 0.5 percent and 0.15 percent, 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,” said Dr. Kim A. Papp of Probity Medical Research and K. Papp Clinical Research Inc., who is lead author of the publication. “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.”

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 DERMIS-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 percent and 0.15 percent in patients with chronic plaque psoriasis. The study enrolled a single-dose, open-label Phase 1 cohort (0.5 percent 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 percent, 0.15 percent, or vehicle). Patients had chronic plaque psoriasis of > six months’ duration with ≤5 percent body surface area involvement. Outcomes included safety (adverse events) and efficacy (percentage change in the product of Target Plaque Severity Score and Target Plaque Area) at week four.

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 percent (P=0.0007) and 0.15 percent (P=0.0011) versus vehicle; significance was reached as early as 2 weeks. For both roflumilast cream doses, 66-percent to 67-percent improvement from baseline was observed at week four, without reaching a plateau, versus 38 percent 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,” said Frank Watanabe, Arcutis’ president and CEOr. “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.”