Arcutis Biotherapeutics Reports Positive Phase 2 Results for ZORYVE Cream in Infants with Atopic Dermatitis

Reuters02-02 21:00

Arcutis Biotherapeutics Reports Positive Phase 2 Results for ZORYVE Cream in Infants with Atopic Dermatitis

Arcutis Biotherapeutics Inc. announced positive topline results from the INTEGUMENT-INFANT Phase 2 clinical trial evaluating ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The study showed that 58% of participants achieved a 75% improvement in the Eczema Area and Severity Index (EASI-75) at Week 4. ZORYVE cream was reported to be well tolerated, with a safety profile consistent with previous studies and no new safety signals identified through four weeks of treatment. The most frequently reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting, with all adverse events described as mild to moderate. The company plans to submit a supplemental New Drug Application (sNDA) for this age group in the second quarter of 2026. The results have already been announced in a company statement.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Arcutis Biotherapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9646820-en) on February 02, 2026, and is solely responsible for the information contained therein.

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The study showed that 58% of participants achieved a 75% improvement in the Eczema Area and Severity Index (EASI-75) at Week 4. ZORYVE cream was reported to be well tolerated, with a safety profile consistent with previous studies and no new safety signals identified through four weeks of treatment. The most frequently reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting, with all adverse events described as mild to moderate. The company plans to submit a supplemental New Drug Application (sNDA) for this age group in the second quarter of 2026. The results have already been announced in a company statement.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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