New Analysis of Organon’s VTAMA® (tapinarof) cream, 1%, Phase 3 Data Showed Early and Consistent Improvement in Patient-Reported Sleep Subdomains in Pediatric Patients Down to 2 Years of Age with Atopic Dermatitis

Key Terms

patient-oriented eczema measure (poem) medical

A patient-oriented eczema measure (POEM) is a short questionnaire patients complete to rate how their eczema affects symptoms and daily life over a recent period. It turns subjective experience into a simple score—like a customer satisfaction rating for a treatment—which helps regulators, doctors and payers judge whether a therapy really improves patients’ lives and can thus influence approvals, prescribing and commercial success.

dermatitis family impact (dfi) medical

A Dermatitis Family Impact (DFI) score is a short questionnaire-based measure that captures how a person’s dermatitis affects their household — including family members’ daily routines, sleep, emotional stress and caregiving time. For investors, DFI matters because it quantifies the broader social and economic burden of skin disease beyond the patient, influencing how payers, regulators and clinicians value treatments and shaping market demand much like measuring collateral damage helps set the price of fixing a problem.

treatment-emergent adverse events medical

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

nasopharyngitis medical

An inflammation of the nose and throat commonly called the common cold, marked by runny nose, sore throat and sneezing. Investors should note it because widespread cases can temporarily lower worker productivity, affect consumer behavior (fewer outings or purchases), increase healthcare and sick-leave costs, and influence demand for certain medicines or services — similar to a short-term weather event that disrupts normal business activity.

phase 3 technical

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

pivotal trials technical

Pivotal trials are the large, definitive clinical studies designed to show whether a drug or medical device works and is safe enough for regulatory approval. Investors watch them like a final exam for a product: passing typically clears the way to sell the therapy and generate revenue, while failing can delay or block approval and sharply reduce a company's value.

• Clinically meaningful improvements in sleep scores, as measured by subdomains of the Patient-Oriented Eczema Measure (POEM) and Dermatitis Family Impact (DFI) assessments, were observed as early as week 1 and continued through week 8

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 sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA cream versus vehicle at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, Pennsylvania, on February 27, 2026. The findings show that VTAMA cream provided early and consistent improvements in the POEM sleep subdomain for pediatric patients down to age 2 with moderate to severe atopic dermatitis (AD) and in the DFI sleep subdomain for family members of patients aged 2-15 years.

“Sleep disturbance is a significant problem for children with atopic dermatitis and their families, and one that I always take time to address in my clinic,” said Dr. Mark Boguniewicz, Professor in the Department of Pediatrics, Division of Allergy and Immunology at National Jewish Health and the University of Colorado School of Medicine, and an author of the analysis being presented at the AAAAI meeting. “When a child with atopic dermatitis struggles through the night, parents and caregivers are often awake as well, sharing in the fatigue and emotional stress associated with ongoing sleep disturbance.”

In the ADORING 1 and ADORING 2 pivotal trials, adults and children (≥2 years; N=813) with moderate to severe AD were randomized 2:1 to VTAMA cream or vehicle once daily for 8 weeks. These findings presented at AAAAI 2026 come from a sub‑analysis of pooled data from 654 children aged 2 to 17 years enrolled in ADORING 1 and ADORING 2. Clinically relevant improvements in sleep subdomains of patient-reported outcomes, as measured by POEM and DFI scores, were seen across all age groups, including pediatric patients down to age 2 with moderate to severe AD and family members of patients aged 2-15 years.

Notable findings include¹:

• Mean POEM sleep subdomain scores significantly improved as early as week 1 with VTAMA cream versus vehicle for children aged 2-6 and 12-17, with improvements in children aged 7-11 observed by week 4.
• Mean changes in POEM sleep scores with VTAMA cream versus vehicle at week 8 were clinically significant across age groups: -1.9 vs. -0.9 for children aged 2-6 (P<0.0001), -1.5 vs. -1.0 for children aged 7-11 (P=0.0029), and -1.2 vs. -0.6 for children aged 12-17 (P<0.0001).
• Mean DFI sleep subdomain scores significantly improved as early as week 1 with VTAMA cream versus vehicle in patients aged 12-15 and as early as week 2 for children aged 2-6 and 7-11.
• Clinically significant improvements in DFI sleep subdomain scores continued through week 8 with VTAMA cream versus vehicle: -1.1 vs. -0.6 for children aged 2-6 (P=0.0002), -0.6 vs. -0.4 for children aged 7-11 (P=0.0049), and -0.4 vs. -0.2 for children aged 12-15 (P=0.0283).

Consistent with the prescribing information, the most frequently reported (≥5% in any group) treatment-emergent adverse events in the ADORING 1 and ADORING 2 clinical trials were folliculitis, headache, and nasopharyngitis.

“These findings demonstrate early and sustained improvements in sleep-related measures, including for those as young as two years of age,” said Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon. “Sleep disturbance is an important and measurable aspect of pediatric atopic dermatitis, and these positive results reinforce our commitment to advancing therapies that address meaningful treatment outcomes across chronic skin conditions. We are encouraged by these findings and look forward to continuing to disseminate data that are clinically relevant for patients, caregivers, and prescribers.”

In December 2024, the US Food and Drug Administration (FDA) approved VTAMA cream for the topical treatment of AD in adults and pediatric patients 2 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.

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.

For more information about VTAMA (tapinarof) cream, 1%, visit www.vtamahcp.com.

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.^2,3 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 about VTAMA as a treatment option for AD and continuing to disseminate clinically relevant data about VTAMA. Forward-looking statements may be identified by words such as “will,” and “look forward to” 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 other 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.

© 2026 Organon group of companies. All rights reserved. US-VTA-113179 02/26

1 Boguniewicz M, Eichenfield LF, Kwong P, Hebert AA. Improvement in sleep and family impact for pediatric patients down to two years of age with atopic dermatitis treated with tapinarof cream 1% once daily in two pivotal phase 3 trials. Poster presented at: American Academy of Allergy, Asthma and Immunology Annual Meeting; February 27 - March 2, 2026; Philadelphia, PA.

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/research/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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Felicia Bisaro

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Source: Organon & Co.