Topical roflumilast foam (ARQ-154) is a foam formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast is the first FDA-approved PDE4 inhibitor. Roflumilast has been used for systemic treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency based on IC50 values (a nonclinical measure of a drug’s potency) than 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 that roflumilast foam has the potential to address the significant need for a new standard of care in seborrheic dermatitis.
Roflumilast foam is nearly identical to roflumilast cream. Roflumilast foam has been uniquely formulated as an emollient, water-based, moisturizing foam that can be used on the scalp or body and is designed to overcome limitations of traditional creams and ointments.
Based on the profile of topical roflumilast foam and prior clinical data with topical roflumilast cream, Arcutis advanced its evaluation in seborrheic dermatitis into Phase 3 development, and has initiated a single pivotal Phase 3 study (STRATUM), with topline data anticipated in the second or third quarter of 2022.
In a Phase 2b study, roflumilast foam significantly improved both scalp and body psoriasis, with 6% of patients achieving S-IGA success at week 8, and significant efficacy shown as early as week 2. Arcutis reported positive topline data from a Phase 2b study in patients with scalp and body psoriasis which affects more than 2.5 million of the 6 million psoriasis patients in the US with active disease. Phase 3 of Arcutis’ program in scalp and body psoriasis has begun enrolling patients, with topline data anticipated in the second half of 2022.
Scalp and Body Psoriasis