The Phase 2b trial in scalp psoriasis is an 8-week, multi-center, multi-national, double blind, vehicle-controlled, study of the safety and efficacy of topical roflumilast foam 0.3% administered once-daily in approximately 300 adult and adolescent patients with plaque psoriasis that includes plaques on the scalp. The primary endpoint of the trial is achievement of an Investigator Global Assessment score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline on the scalp (S-IGA) at week 8. Multiple secondary endpoints will also be evaluated.
Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4 inhibitor) that the Company is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp.
“An estimated 8.6 million Americans are afflicted with chronic psoriasis, and nearly half of those people have scalp involvement, an area where topical treatment of scalp plaques is complicated by the difficulty of delivering topical drugs under the hair and to the surface of the skin,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “We developed roflumilast foam as a convenient, once daily, easy-to-use foam that is safe for chronic use and appropriate for application in hair-bearing areas, such as the scalp, where a cream, lotion, or ointment is not suitable. We believe roflumilast foam may provide a new treatment option for physicians and patients, with the potential to show significant symptomatic improvement similar to high-potency steroids, while at the same time maintaining a low risk of toxicity or side effects.”
Arcutis believes roflumilast foam has significant potential as a scalp psoriasis treatment. Roflumilast foam is nearly identical to ARQ-151 (topical roflumilast cream), Arcutis’ topical cream PDE4 inhibitor that has demonstrated statistically significant improvements of psoriasis symptoms and a favorable tolerability profile in two separate Phase 2 studies. Psoriasis plaques on the scalp are identical to plaques elsewhere on the body, so the roflumilast foam psoriasis results should be highly predictive.
Roflumilast foam is a topical foam formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25 to 300 fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.