Arcutis Biotherapeutics, Inc. (ARQT), a commercial-stage biopharmaceutical company, announced new positive data from the INTEGUMENT-INFANT Phase 2 trial of ZORYVE (roflumilast) 0.05% cream, demonstrating reduced signs and symptoms of atopic dermatitis in infants aged 3 months to less than 24 months with mild to moderate disease.
Company ProfileArcutis focuses on developing and commercialising treatments for dermatological diseases.
The company's lead product is ZORYVE, a topical roflumilast cream for the treatment of plaque psoriasis and atopic dermatitis. It also develops ZORYVE foam for the treatment of seborrheic dermatitis, scalp, and body psoriasis.
Trial OverviewThe INTEGUMENT-INFANT open-label trial evaluated the safety and tolerability of once-daily ZORYVE cream 0.05% in 101 infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis over four weeks.
Key FindingsIn the new data, among 96 participants who completed four weeks of treatment, the results included the following.
-34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success defined as a score of 0 (Clear) or 1 (Almost Clear) with a =2-grade improvement.
-49% of infants achieved a vIGA-AD score of clear or almost clear (0 or 1) at week 4, and 24% already at week 2.
-For those infants with at least mild scalp involvement at baseline (n=40), 67.5% achieved vIGA-scalp success (scalp Clear or Almost Clear (0 or 1) with =2-point improvement from baseline) at week 4.
-66.7% of infants achieved at least a 25% improvement from baseline in pruritus or itching based on the Dynamic Pruritus Scale (DPS-25) at four hours (n=87), 58.6% at one hour (n=87), and 46.6% at 10 minutes (n=88).
The most frequently reported adverse events in 3% and more included diarrhoea, nasopharyngitis, upper respiratory tract infection, and vomiting.
Also, Investigational ZORYVE (Roflumilast) cream 0.05% was well tolerated, with safety findings consistent with prior paediatric experience in the INTEGUMENT program.
The results were presented during a late-breaking podium presentation at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, CO.
Upcoming MillstonesThese data may support Arcutis' planned supplemental New Drug Application for ZORYVE cream 0.05% in infants aged 3 months to less than 24 months, which the company expects to submit in the second quarter of 2026.
ConclusionAtopic dermatitis is the most common form of eczema, and, according to Grand View Research, the global atopic dermatitis drugs market size was estimated at $17.64 billion in 2024 and is projected to reach $29.88 billion by 2030, growing at a CAGR of 9.02% from 2025 to 2030.
ARQT has traded between $11.86 and $31.77 in the last year. The stock closed Friday's trade at $21.22, down 5.18%.
In the overnight market, ARQT is up 1.32% at $21.50.
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