Arcutis Biotherapeutics(ARQT) Newsfilter·2025-02-24 13:00Core Insights - Arcutis Biotherapeutics announced positive results from the pivotal phase 3 trial of ZORYVE (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2 to 5 years [1][2][3] Efficacy Results - ZORYVE cream 0.05% demonstrated significant improvements in multiple efficacy endpoints, including a statistically significant primary efficacy endpoint of IGA Success and a 75% improvement in Eczema Area and Severity Index (EASI-75) at Week 4 [2][4] - 25.4% of children treated with ZORYVE achieved vIGA-AD Success compared to 10.7% for the vehicle group (P<0.0001) [4] - Rapid improvement in itch was observed within 24 hours of the first application, with 35.3% of children achieving a four-point reduction in Worst Itch Numeric Scale (WI-NRS) at Week 4 [5][6] Study Design - The INTEGUMENT-PED trial was a Phase 3, double-blind, vehicle-controlled study involving 652 children with a mean Body Surface Area (BSA) of 22% [3][4] - The treatment was applied once daily for four weeks, with significant improvements noted as early as Week 1 [4][5] Safety and Tolerability - ZORYVE cream was well-tolerated, with low incidence of Treatment Emergent Adverse Events (TEAEs) similar in both active and vehicle groups [6] - The most common adverse events included upper respiratory tract infection, diarrhea, and vomiting, all occurring in less than 4.1% of patients [6] Market Potential - Approximately 1.8 million children aged 2 to 5 in the U.S. are affected by atopic dermatitis, indicating a significant market opportunity for ZORYVE cream if approved [4][5] - A Supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% has been submitted to the FDA, with potential approval anticipated later this year [6][7]