Topical roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase-4 (PDE4), an intracellular enzyme that increases the production of proinflammatory mediators and decreases the 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 systemic treatment of plaque psoriasis and the topical treatment of atopic dermatitis. Topical roflumilast cream is a highly potent, selective PDE4 inhibitor in a convenient, once-daily formulation that Arcutis is developing for chronic plaque psoriasis and atopic dermatitis.
In February 2021, we reported positive Phase 3 data on topical roflumilast cream in plaque psoriasis.
In clinical trials, roflumilast cream demonstrated robust efficacy coupled with favorable safety and tolerability that, if approved, could enable chronic use anywhere on the body.
Arcutis’ NDA submission is supported by positive data from Arcutis’ pivotal Phase 3 program. DERMIS 1 and DERMIS 2 (Trials of PDE4 inhibition with Roflumilast for the Management of plaque psoriasIS One and Two) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies to evaluate the safety and efficacy of roflumilast cream 0.3%.
We previously completed a 136-patient Phase 2 proof-of-concept study of topical roflumilast cream. In this study, topical roflumilast cream demonstrated symptomatic improvement across endpoints and favorable tolerability in this patient population. The higher dose tested demonstrated a trend towards significance on the primary endpoint. Both doses tested were statistically superior to vehicle on key secondary endpoints.