Arcutis Biotherapeutics Inc ARQT announced topline results from its INTEGUMENT-1 pivotal Phase 3 trial of roflumilast cream 0.15% for mild to moderate atopic dermatitis.
The study met its primary endpoint with 32.0% of individuals treated with roflumilast cream 0.15% achieving IGA Success – Atopic Dermatitis score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4, compared to 15.2% of individuals treated with vehicle.
About 43.2% of individuals treated with roflumilast cream 0.15% achieved a 75% reduction in Eczema Area and Severity Index (EASI-75) at Week 4 compared to 22.0% treated with vehicle.
About 33.6% of individuals treated with roflumilast cream achieved a four-point reduction on Worst Itch Numeric Scale at Week 4 (vs. 20.7% for vehicle-treated subjects).
Arcutis anticipates topline results from the identically designed pivotal Phase 3 trial INTEGUMENT-2 by the end of 2022.
If successful, the company intends to submit a supplemental marketing application in 2023 for roflumilast cream 0.15% for mild to moderate AD in individuals aged six years and older.
Price Action: ARQT shares are up 3.55% at $19.38 on the last check Tuesday.
