Arcutis Biotherapeutics, Inc. announced that it will advance its program to develop topical roflumilast foam (ARQ-154) as a treatment for seborrheic dermatitis into Phase 3 following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The Phase 3 program will consist of a single pivotal trial, which the Company anticipates initiating in the second or third quarter of 2021. Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor. Roflumilast foam is a once-daily topical foam formulation of a highly potent and selective PDE4 inhibitor that Arcutis is developing particularly to treat inflammatory dermatoses in hair-bearing areas of the body such as the scalp, although it is usable in all areas of the body. Roflumilast has been approved by the FDA for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to-300 fold) than the two other FDA-approved PDE4 inhibitors. 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 roflumilast foam has significant potential as a treatment for seborrheic dermatitis. In a recently completed Phase 2 study of roflumilast foam in seborrheic dermatitis, roflumilast foam demonstrated statistically significant improvement over the vehicle foam on the trial’s primary endpoint, Investigator Global Assessment (IGA) success, and multiple secondary endpoints including the reduction of itch. Once-daily roflumilast foam also demonstrated a favorable safety and tolerability profile. Additionally, other than a very small change in the formulation, roflumilast foam is identical to roflumilast cream (ARQ-151), Arcutis’ investigational topical cream PDE4 inhibitor, which has demonstrated symptomatic improvement and a favorable tolerability profile in clinical trials in plaque psoriasis, including chronic treatment of psoriasis, as well as encouraging results in atopic dermatitis. Arcutis is currently conducting a Phase 2 long-term safety study in seborrheic dermatitis. This is a multicenter, open-label study of roflumilast foam 0.3% applied once daily in adolescent and adult patients with seborrheic dermatitis and includes patients who were treated previously in the Phase 2 trial, as well as patients naïve to treatment with topical roflumilast foam. Periodic clinic visits include assessments for clinical safety, application site reactions, and disease improvement, or progression.