Topical roflumilast foam (ARQ-154) is a foam formulation of a highly potent and selective PDE4 inhibitor (roflumilast) which Arcutis is developing for the treatment of inflammatory dermatoses, particularly in hair-bearing areas of the body, such as the scalp.
PDE4 is 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. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical and 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.
In clinical trials, once-daily roflumilast foam has demonstrated robust efficacy coupled with favorable safety and tolerability that, if approved, could enable chronic use anywhere on the body.
Based on positive data from STRATUM (STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis), a Phase 3, parallel-group, double-blind, vehicle-controlled study, Arcutis plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the first quarter of 2023.
Plaque psoriasis impacts 9 million people in the United States, and approximately 40% of individuals have involvement of the scalp.
Arcutis conducted ARRECTOR (A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis), a parallel-group, double-blind, vehicle-controlled pivotal Phase 3 study to assess the efficacy and safety of roflumilast foam 0.3% or a matching vehicle administered once daily in subjects, aged 12 or older, with scalp and body psoriasis.
In this pivotal Phase 3 study, roflumilast foam significantly improved both scalp and body psoriasis. At week 8, 67.3% of individuals treated with roflumilast foam achieved Scalp-Investigator Global Assessment (S-IGA) success compared to 28.1% of individuals treated with vehicle.
Additionally, 46.5% of individuals treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) success at week 8 compared to 20.8% of individuals treated with vehicle. Once-daily roflumilast foam also demonstrated a favorable safety and tolerability profile. Based on this positive data, Arcutis intends to submit a supplemental NDA to the FDA.
Trial of PDE4 Inhibition With Roflumilast for the Management of Seborrheic Dermatitis (STRATUM)
Efficacy and Safety of Roflumilast Foam 0.3% in Patients With Seborrheic Dermatitis in a Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study