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, atopic dermatitis, 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. Topical roflumilast cream is a highly potent, selective PDE4 inhibitor in a convenient, once-daily formulation that Arcutis is studying in atopic dermatitis.
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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 of roflumilast cream 0.15% demonstrated a trend towards significance on the primary endpoint. Both doses tested (0.15% and 0.05%) were statistically significant compared to vehicle on key secondary endpoints.
Arcutis’ pipeline will change as molecules move through the drug development process. Safety and efficacy of these investigational agents have not been established. These uses have not been approved by the US Food and Drug Administration or other regulatory authorities.