Organon Presents New Analysis of Pooled Post-Hoc Phase 3 Data on VTAMA® (tapinarof) cream, 1%, Demonstrating Consistent Efficacy in Atopic Dermatitis Across Diverse Patient Subgroups at ACAAI

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• VTAMA demonstrated consistent response rates for disease severity and itch, measured by ≥75% improvement in Eczema Area and Severity Index (EASI75) and Peak Pruritus-Numeric Rating Scale (PP-NRS), across subgroups based on baseline percent body surface area (BSA) affected, disease duration, and prior use of systemic therapies among patients with moderate to severe atopic dermatitis^1,2

JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will present results from a post hoc sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating the efficacy of VTAMA cream versus vehicle across diverse patient subgroups in a session at the 2026 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Phoenix, Arizona, on November 14, 2026.

The findings demonstrated early and consistent improvements in disease severity—measured by EASI75 and Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD^®)—and in itch, as measured by PP-NRS, across all evaluated patient subgroups with moderate to severe atopic dermatitis.

“Physicians want assurances that the therapies they recommend have broad applicability across the diverse patients they see in their offices daily,” said Luz Fonacier, MD, Professor, Department of Medicine at NYU Grossman Long Island School of Medicine and lead author of the analysis being presented at ACAAI. “The consistent responses observed in patients with greater body surface area involvement or longer disease duration, as well as those who had no prior treatment with systemic therapies or discontinued systemic therapies, demonstrate the potential for this non-steroidal topical treatment to help provide disease control.”

In the ADORING 1 and ADORING 2 pivotal trials, adults and children ≥2 years (N=813) with moderate to severe atopic dermatitis were randomized to VTAMA cream or vehicle once daily for 8 weeks.

Notable findings from this post-hoc pooled analysis include consistent EASI75, vIGA-AD and PP-NRS response rates across all evaluated patient subgroups starting at Week 1 and maintained through Week 8. Efficacy findings at Week 8 are as follows:¹

• EASI75 response
  • Percent BSA involvement: <10%, 57.8% vs. 32.2%; ≥10%, 64.4% vs. 23.2%
  • Disease duration: 0–5 years: 0–5 years, 70.0% vs. 31.8%; ≥6 years, 58.8% vs. 21.7%
  • History of systemic atopic dermatitis treatment: prior treatment, 64.3% vs. 3.8%; no prior treatment, 62.4% vs. 28.4%
• vIGA-AD response
  • Percent BSA involvement: <10%, 53.9% vs. 22.0%; ≥10%, 46.0% vs. 15.2%
  • Disease duration: 0–5 years: 0–5 years, 53.2% vs. 17.6%; ≥6 years, 45.3% vs. 16.7%
  • History of systemic atopic dermatitis treatment: prior treatment, 45.7% vs. 7.7%; no prior treatment, 48.4% vs. 18.3%
• PP-NRS response
  • Percent BSA involvement: <10%, 61.3% vs. 26.1%; ≥10%, 58.6% vs. 35.8%
  • Disease duration: 0–5 years: 0–5 years, 64.9% vs. 30.6%; ≥6 years, 56.1% vs. 35.2%
  • History of systemic atopic dermatitis treatment: prior treatment, 55.0% vs. 20.8%; no prior treatment, 60.0% vs. 35.3%

VTAMA was well tolerated, with the most frequently reported (≥3% in any group) treatment-emergent adverse events being folliculitis, headache, upper respiratory tract infection, and nasopharyngitis.

“Atopic dermatitis is a chronic condition that can affect patients in different ways over the course of their lives, and treatment needs can evolve with the disease,” said Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon. “For patients and their physicians, having a non-steroidal atopic dermatitis treatment option is critical. These new pooled data reinforce the potential for VTAMA cream to help provide disease control across diverse patient types.”

VTAMA cream is the only aryl hydrocarbon receptor (AhR) agonist indicated for the treatment of both plaque psoriasis in adults and atopic dermatitis in adults and pediatric patients 2 years and older. In December 2024, the US Food and Drug Administration (FDA) approved VTAMA cream for the topical treatment of atopic dermatitis in adults and pediatric patients two years of age and older. VTAMA cream was also approved by the FDA in May 2022 for the topical treatment of plaque psoriasis in adults.

About the Phase 3 Program for VTAMA cream in Atopic Dermatitis

ADORING was the Phase 3 AD clinical development program for VTAMA cream, consisting of two 8-week pivotal trials, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week, open-label, long-term extension trial.

About VTAMA

INDICATIONS: VTAMA^® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for:

• the topical treatment of plaque psoriasis in adults
• the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older

SELECTED SAFETY INFORMATION

Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.

Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.

Before prescribing VTAMA cream, please read the Prescribing Information.

About Atopic Dermatitis (AD)

AD, commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting an estimated 26 million people in the U.S. alone and up to 10% of adults worldwide.^3,4 AD occurs most frequently in children, affecting up to 20% worldwide, including nearly 10 million children in the U.S.^3,4 The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck.² Itching is an especially bothersome symptom for those with AD, and tends to worsen at night.³

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok, and Facebook.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s intent to present results at the 2026 ACAAI Annual Scientific Meeting and the potential benefits, value, positioning and future role of VTAMA® (tapinarof) cream, 1% as a treatment option for patients with atopic dermatitis. Forward-looking statements may be identified by words such as “will,” “potential,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

vIGA-AD is a registered trademark of Eli Lilly and Co.

© 2026 Organon group of companies. All rights reserved. US-VTA-113529 10/26

1 Fonacier L, Boguniewicz M, Guskey M, Deng A, Silverberg JI. Tapinarof cream 1% in atopic dermatitis: consistent efficacy over time across %BSA and other subgroups. Presented at: American College of Allergy, Asthma & Immunology Annual Scientific Meeting; September 11-14, 2026; Orlando, Florida
2 Atopic dermatitis. National Institute of Arthritis and Musculoskeletal and Skin Diseases. November 2022. Accessed August 19, 2025. https://www.niams.nih.gov/health-topics/atopic-dermatitis.
3 Eczema stats. National Eczema Association. Accessed June 5, 2025. https://nationaleczema.org/eczema-facts/.
4 Global Report on Atopic Dermatitis 2022. International League of Dermatological Societies; 2022. Accessed February 25, 2025. https://www.eczemacouncil.org/assets/docs/global-report-on-atopic-dermatitis-2022.pdf.

 

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Source: Organon & Co.