New Data Show Early and Consistent Response to VTAMA (tapinarof) Cream, 1%, in Children Aged 2+ with Atopic Dermatitis, Including Those With Associated Comorbidities

Organon (NYSE: OGN), a global independent healthcare company with a focus on women’s health, will present results from a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA cream versus vehicle at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Orlando, Florida, on November 8, 2025. The new data demonstrate that VTAMA cream provided early and consistent response for children aged 2-17 with atopic dermatitis (AD), with or without atopic comorbidities such as asthma, allergic rhinitis and food allergies.

“As many children with atopic dermatitis may also be living with potential comorbidities such as allergies and asthma that may add to their disease burden,¹ it’s important to understand the effects of approved treatments on this population,” said Dr. Luz Fonacier, Professor of Medicine, Section Head of Allergy and Training Program Director, NYU Grossman Long Island School of Medicine. “These reassuring data show tapinarof cream provided early relief, including on bothersome symptoms such as itch, for children as young as 2 years of age with and without comorbidities.”

In the ADORING 1 and ADORING 2 pivotal trials, adults and children (≥2 years; N=813) with moderate to severe AD were randomized to VTAMA cream or vehicle once daily for 8 weeks. The results presented at ACAAI 2025 are from a sub-analysis of the 654 children in the trials aged 2-17, with and without comorbidities associated with AD. The data highlight improvements in clinically relevant patient-reported outcomes, Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response, and Eczema Area and Severity Index (EASI) scores in children aged 2-17 years, regardless of comorbidities.

Notable findings include:

• Early improvements in skin clearance were observed, with significant differences in vIGA-AD response rates as early as week 1 and maintained through week 8 in children with or without atopic comorbidities (with comorbidities: 42.3% with VTAMA cream vs. 11.8% with vehicle, p<0.0001; without comorbidities: 49.5% vs. 14.8%, respectively, p<0.0001).
• Improvement in eczema severity, as measured by EASI scores, was observed as early as week 2 and sustained through week 8 (with comorbidities: 54.5% with VTAMA cream vs. 21.8% with vehicle, p<0.0001; without comorbidities: 63.1% vs. 20.4%, respectively, p<0.0001).
• Improvements in patient-reported outcomes, including sleep, as measured by total mean Patient-Oriented Eczema Measure (POEM) and mean POEM sleep scores (based on a single question within the POEM and analyzed separately from the total POEM score), were noted as early as week 1 and maintained through week 8 (total POEM with comorbidities: 6.9 with VTAMA cream vs. 12.0 with vehicle, p<0.0001; total POEM without comorbidities: 6.7 vs. 11.9, respectively, p<0.0001; POEM sleep with comorbidities: 0.9 with VTAMA cream vs. 1.4 with vehicle, p=0.0003; POEM sleep without comorbidities: 0.6 vs. 1.4, respectively, p<0.0001).
• Clinically meaningful improvements in itch (a ≥4-point Peak Pruritus- Numeric Rating Scale [PP-NRS] response) were observed at week 2, based on responder analysis, with continued improvement through week 8 (with comorbidities: 55.6% with VTAMA cream vs. 36.3% with vehicle, p=0.0043; without comorbidities: 63.3% vs. 29.2%, respectively, p<0.0001).

Consistent with the prescribing information, the most frequently reported treatment-emergent adverse events in the sub-analysis of children aged 2-17 in the ADORING 1 and ADORING 2 trials were folliculitis (7.8%), upper respiratory tract infection (4.6%) and headache (3.7%).