(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. ARQ-151 is a topical 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.
We have completed an 89-patient randomized, double blind, vehicle-controlled multinational, multi-center Phase 2a study of ARQ-151, and have an ongoing 332-patient randomized, double blind multinational, multi-center Phase 2b study of ARQ-151, both in plaque psoriasis. In the Phase 2a study, ARQ-151 produced statistically significant reductions 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 ARQ-151 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.