Clinical Development

Topical roflumilast foam (ARQ-154) is a 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 based on IC50 values (a non-clinical measure of a drug’s potency) than any other disclosed PDE4 inhibitor.  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.

Arcutis believes topical roflumilast foam has significant potential as a seborrheic dermatitis treatment. Topical roflumilast foam is nearly identical to topical roflumilast cream, Arcutis’ investigational topical cream PDE4 inhibitor that has demonstrated symptomatic improvement and a favorable tolerability profile based on the Company’s clinical trials in plaque psoriasis.  Based on the profile of topical roflumilast foam and prior clinical data with topical roflumilast cream, Arcutis has initiated a Phase 2b clinical trial to evaluate topical roflumilast foam for seborrheic dermatitis.