ARQT - Arcutis to advance roflumilast foam into phase 3 development for treatment of seborrheic dermatitis

Arcutis Biotherapeutics (ARQT) announces 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. FDA.The Phase 3 program will consist of a single pivotal trial, which the company expects 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, and has been approved by the FDA for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease ((COPD)) since 2011.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 started pivotal Phase 3 clinical trials evaluating topical roflumilast cream ARQ-151 as a potential treatment for atopic dermatitis, earlier this month.

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Arcutis to advance roflumilast foam into phase 3 development for treatment of seborrheic dermatitis