Clinical Development

ARQ-154 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 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 ARQ-154 has significant potential as a seborrheic dermatitis treatment.  ARQ-154 is nearly identical to ARQ-151, 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 ARQ-154 and prior clinical data with ARQ-151, Arcutis has initiated a Phase 2b clinical trial to evaluate ARQ-154 for seborrheic dermatitis.