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New Analysis of Organon’s VTAMA® (tapinarof) cream, 1% Phase 3 Data Shows Atopic Dermatitis Disease Activity Remained Low After Treatment-Free Interval in Adults and Children 2 Years of Age and Older
Low disease activity was observed after a mean duration of 80 consecutive days off-treatment following success with VTAMA cream, with a mean weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score of 2.9 at the end of the treatment-free interval
Data presented as late breaker at 2025 American Academy of Dermatology (AAD) Annual Meeting
JERSEY CITY, N.J., March 08, 2025--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced results from an analysis of the Phase 3 ADORING 3 open-label, long-term extension study evaluating VTAMA® (tapinarof) cream, 1% once daily in adults and children 2 years of age and older with atopic dermatitis (AD), also known as eczema. The findings demonstrate that AD disease activity remained mild in patients who had achieved treatment success and subsequently entered a treatment-free interval lasting on average 80 days. These results were presented during a late-breaking research session today at the 2025 American Academy of Dermatology (AAD) Annual Meeting.
"For patients with atopic dermatitis, the benefits of many topical treatments are often short-lived, and for some patients, their disease rapidly reappears after taking a break from topical treatments," said Jonathan Silverberg, M.D., Ph.D., M.P.H., George Washington University School of Medicine and Health Sciences. "As a physician, I’m encouraged that at the end of a break from treatment with VTAMA cream, patients’ AD remained mild. I’m excited to see these data support the use of VTAMA cream to potentially provide lasting results for itch, which is the universal and most burdensome symptom of AD."
ADORING 3 (N=728) was a 48-week open-label, long-term extension study that enrolled eligible patients from the pivotal Phase 3 ADORING 1 and ADORING 2 trials, patients from a 4-week maximal usage pharmacokinetics study, and VTAMA cream-naive patients 2-17 years of age with either mild, moderate, or severe AD that did not meet inclusion criteria in ADORING 1 and ADORING 2. In ADORING 3, those who entered with or achieved completely clear skin (n=378), defined as a validated Investigator Global Assessment for AD (vIGA-AD™) score of 0, stopped using VTAMA cream and were assessed for maintenance of vIGA-AD of 0 (clear) or 1 (almost clear) off-treatment. Patients whose AD returned to a vIGA-AD of 2 or higher (mild or above) were retreated with VTAMA cream until complete disease clearance was achieved again or until study completion.
The new results demonstrate that, at the end of the first treatment-free interval, which lasted an average of 79.8 consecutive days, 84% of patients had a vIGA-AD score of 2 (mild). Itch, which was assessed with the patient reported Peak Pruritus Numerical Rating Scale (PP-NRS) score ranging from 0 to 10, remained low with a mean weekly PP-NRS score of 2.9. The mean Eczema Area and Severity Index (EASI) score was 3.4, indicating mild disease.
The most frequent treatment-emergent adverse events (TEAEs) in ADORING 3 included folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%); trial discontinuations due to TEAEs were low (2.6%). Adverse events of special interests including follicular events, contact dermatitis, and headache were mostly mild or moderate and associated with low discontinuation rates (1.0%, 0.4%, and 0%, respectively).
"These data reinforce the efficacy of VTAMA cream in atopic dermatitis, including the durability of effect among patients in the study, including children as young as two years old," said Juan Camilo Arjona Ferreira, M.D., Head of Research and Development and Chief Medical Officer at Organon. "Knowing the profound impact that atopic dermatitis can have on the lives of patients, and oftentimes their caregivers, the possibility to receive over two months of relief without needing to reapply treatment is meaningful and speaks to our mission of creating a healthier every day."
In December 2024, the U.S. Food and Drug Administration (FDA) approved VTAMA (tapinarof) cream, 1% 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 on May 24, 2022, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults.
IMPORTANT SAFETY INFORMATION
Indications: VTAMA (tapinarof) cream, 1% is an aryl hydrocarbon receptor 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.
Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: red raised bumps around the hair pores (folliculitis); pain or swelling in the nose and throat (nasopharyngitis); skin rash or irritation, including itching and redness, peeling, burning, or stinging (contact dermatitis); headache; itching (pruritus); and flu (influenza).
Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection; red raised bumps around the hair pores (folliculitis); lower respiratory tract infection; headache; asthma; vomiting; ear infection; pain in extremity; and stomach-area (abdominal) pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information about VTAMA (tapinarof) cream, 1%, visit www.vtamahcp.com.
About ADORING
ADORING is the Phase 3 AD clinical development program for VTAMA (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, long-term extension study.
About Atopic Dermatitis
AD, commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting over 26 million people in the U.S. alone and up to 10% of adults worldwide.1,2,3 AD occurs most frequently in children, affecting up to 20% worldwide.2,3 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.1 Itching is an especially bothersome symptom for those with AD, and tends to worsen at night.2,4,5
About Organon
Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers over 70 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon’s scale and agile presence in fast growing international markets.
Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.
Except for historical information, this press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the potential uses and efficacy of VTAMA cream. Forward-looking statements may be identified by words such as "potentially," "opportunity," "continue," "will," "pursuing," "future," or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’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.
Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy; weakening of economic conditions that could adversely affect the level of demand for VTAMA; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on our product development and commercialization plans; governmental initiatives that adversely impact Organon’s marketing activities; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our products lose patent protection; disruptions at the U.S. Food and Drug Administration, the U.S. Securities and Exchange Commission (the "SEC") and other U.S. and comparable foreign government agencies; and the failure by us or our third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).
_________________________ 1 Atopic Dermatitis. NIAMS website. Available at: https://www.niams.nih.gov/health-topics/atopic-dermatitis. Accessed March 2025. 2 Eczema Stats. NEA website. Available at: https://nationaleczema.org/research/eczema-facts/. Accessed March 2025. 3 Global Report on Atopic Dermatitis 2022. Eczema Council website. Available at: https://www.eczemacouncil.org/assets/docs/global-report-on-atopic-dermatitis-2022.pdf. Accessed March 2025. 4 Beckman L, Hagquist C, Svensson Å, Langan SM, Von Kobyletzki L. Relationship between eczema and self-reported difficulties keeping up with school education: A cross-sectional study. Acta Derm Venereol. June 2023;103:5268. 5 Cheng BT, Patel MS, Xu M, et al. Timing of itch among children with atopic dermatitis. Ann Allergy Asthma Immunol. February 2022;128(5):603–605.
