Clinical Development

Topical roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase type 4 (PDE4, an intracellular enzyme that increases the production of proinflammatory mediators and decreases production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and chronic obstructive pulmonary disease (COPD). PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical or systemic treatment of plaque psoriasis and atopic dermatitis. Topical roflumilast cream is a cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast) that has been approved for the systemic treatment of COPD since 2011 and that is many-fold more potent than any other as yet disclosed PDE4 inhibitor.  Arcutis is developing topical roflumilast cream as a potential treatment for plaque psoriasis and atopic dermatitis.

In our plaque psoriasis development program, we have completed a 332-patient Phase 2b study and an 89-patient Phase 2a study of topical roflumilast cream. In the recent Phase 2b study, topical roflumilast cream produced statistically significant reductions compared to vehicle in the signs of plaque psoriasis, and also demonstrated excellent safety and tolerability in this population. Based on the clinical data we have generated to date, we believe that topical roflumilast cream is uniquely suited to address the unmet needs in topical treatment of psoriasis, offering efficacy on par with high potency steroids, the ability to use the drug chronically, an excellent safety and tolerability profile, and the ability to use in all anatomical areas.

In our atopic dermatitis development program, we have completed a 136-patient Phase 2 proof-of-concept study of topical roflumilast cream.  In this study, topical roflumilast cream demonstrated consistent evidence of symptomatic improvement across endpoints and favorable tolerability in this patient population.  The higher dose tested demonstrated trend towards significance on primary endpoint.  Both doses tested were statistically superior to vehicle on key secondary endpoints.  We plan to advance topical roflumilast cream development in atopic dermatitis, with Phase 2b initiation anticipated in 2H 2020.