Dermavant Announces Positive Data from the ADORING Phase 3 Development Program in Atopic Dermatitis with VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old

- 80.7% (574/711) of patients achieved EASI75 (at least a 75% reduction in disease burden) in an integrated analysis of all the ADORING Program studies -

- 77.9% (218/280) of patients ≥12 years old with a baseline PP-NRS (itch) score ≥4 achieved a ≥4-point reduction in PP-NRS. In the ADORING pivotal studies, a mean itch reduction was observed as early as 24 hours after first application -

- 73% (519/711) of patients included in the integrated analysis achieved a vIGA-AD™ score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline -

- 51.2% (373/728) of patients achieved complete disease clearance (vIGA-AD score of 0) in an interim analysis of the ADORING 3 open-label, long-term extension study –

- No new safety signals were observed with up to 56 weeks of treatment -

- Data from these analyses will be included in the sNDA submission for VTAMA cream, 1% expected in Q1 2024 -

Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced new positive efficacy and safety data from analyses of the company’s ADORING Phase 3 development program in atopic dermatitis (AD) with VTAMA® (tapinarof) cream, 1% in adults and children as young as 2 years old.

VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant and steroid-free, topical cream for both acute treatment and long-term management of AD. VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. and is the same strength and formulation being studied in the ADORING Phase 3 development program for AD.

ADORING 1 and ADORING 2 were two identical, double-blind, randomized, vehicle-controlled Phase 3 studies that evaluated the efficacy and safety of VTAMA cream, 1% in adults and pediatric patients down to 2 years old who had a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 (moderate) to 4 (severe) at baseline. ADORING 3 is an ongoing open-label, long-term extension study being conducted to evaluate the safety and efficacy of VTAMA cream, 1% in patients with AD for up to 48 weeks of total treatment. The ADORING 3 study, which consists of 728 patients in total, includes patients who previously completed ADORING 1, ADORING 2, or the Maximal Usage Pharmacokinetics (MUPK) study for AD. ADORING 3 also includes 76 directly enrolled pediatric patients who did not meet the criteria for enrollment in the ADORING 1 and ADORING 2 pivotal trials because their AD was either mild or too severe.

Dermavant completed an interim analysis of data from ADORING 3. The company also completed a planned integrated analysis of data including 711 patients from ADORING 1, ADORING 2, ADORING 3 and the MUPK study who had a vIGA-AD score of 3 (moderate) or greater prior to any treatment with VTAMA cream. The data from these analyses will be included in the company’s Supplemental New Drug Application (sNDA) submission to the U.S. Food and Drug Administration (FDA), expected in Q1 of 2024.

Analyses of Efficacy Data

• The integrated analysis across the ADORING development program showed that efficacy continued to improve beyond the 8-week double blind treatment period in ADORING 1 and ADORING 2 across multiple endpoints including:
  • vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline was observed in 73% (519/711) of patients included.
  • 80.7% (574/711) of patients achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75).
  • 77.9% (218/280) of patients ≥12 years old with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score ≥4 achieved a ≥4-point reduction in PP-NRS. In the ADORING pivotal studies, a mean itch reduction was observed as early as 24 hours after first application.
  • 92.3% (656/711) of patients achieved at least a 1-grade improvement in vIGA-AD score.
• The interim analysis of the ADORING 3 open-label, long-term extension study demonstrated that 51.2% (373/728) of patients achieved complete disease clearance (vIGA-AD score of 0).

“In the analyses of the ADORING development program, approximately 81% of the patient population in the integrated analysis achieved EASI75 using VTAMA cream, and approximately 51% of patients in ADORING 3, including both adults and children as young as 2 years old, achieved complete disease clearance with a vIGA-AD score of 0,” said Philip Brown, M.D., J.D., Chief Medical Officer of Dermavant. “Importantly, in addition to the efficacy data reported today, no new safety signals were observed, further supporting VTAMA cream’s clinical profile and its potential ability to achieve long-term disease control.”

Dr. Brown continued, “Turning to long-term disease management, the ADORING 3 study design dictated that when patients achieved complete disease clearance (vIGA-AD score of 0), VTAMA cream was withdrawn and patients were monitored until their AD flared to mild (vIGA-AD ≥2). While the ability for a topical monotherapy to achieve complete disease clearance in over 50% of the patient population is significant, we also observed that those patients were able to maintain an extended period of flare-free days off therapy— i.e., a ‘remittive effect’ – potentially giving patients the ability to safely manage and have control over their disease on a long-term basis without the need for daily or intermittent use of VTAMA cream. Overall, we are highly encouraged by the data from the ADORING development program to date and believe that, if approved by the FDA, VTAMA cream may help address a significant unmet need as an important steroid-free, topical treatment option for millions of patients who suffer from atopic dermatitis, including both adults and children as young as 2 years old.”

ADORING 3 Interim Analysis Safety Data

• VTAMA cream, 1% was well-tolerated across all treated areas, including sensitive skin and intertriginous locations, as assessed by both patients and investigators.
• No new safety signals were observed with long-term use. The study discontinuation rate in ADORING 3 due to adverse events (AEs) was 2.6% (19/728).
• The majority of AEs were mild to moderate in nature with the most commonly reported AEs in ADORING 3 being folliculitis, nasopharyngitis and upper respiratory tract infection.
• There were no treatment-related serious adverse events (SAEs) reported.

“Atopic dermatitis is a burdensome disease, especially for pediatric patients, the most frequently affected patient population. The integrated analysis data from the ADORING development program are particularly encouraging as they show a high level of efficacy in a diverse patient population, including patients down to 2 years of age, who are in need of a treatment option such as VTAMA cream that has demonstrated a positive safety and tolerability profile and potential long-term disease control in the ADORING studies,” said Eric Simpson, MD, MCR, the Frances J. Storrs Medical Dermatology Professor and Director of CLEAR Eczema Center, at the Oregon Health & Science University. “If approved for the treatment of atopic dermatitis, VTAMA cream’s efficacy and safety profile combined with its rapid onset of itch reduction, the most common symptom of atopic dermatitis, could provide an important new treatment option for not only patients suffering from the disease but also for their caregivers and the healthcare professionals treating them.”

“The highly encouraging data reported today is a significant milestone for patients suffering with atopic dermatitis and their families, and I am extremely thankful to all the patients, their families, and the investigators involved in the ADORING development program,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “We are focused on compiling our sNDA data for submission that is expected in Q1 of 2024 and we look forward to making VTAMA cream, 1% available as a potential treatment option for both adults and children suffering from atopic dermatitis as expeditiously as possible, subject to regulatory approval.”

On May 24, 2022, Dermavant announced that the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults. The approval made VTAMA cream the first non-steroidal topical novel chemical entity launched for plaque psoriasis in the U.S. in more than 25 years. VTAMA cream is approved for mild, moderate, and severe plaque psoriasis - with no label safety warnings or precautions, restrictions on duration of use or body surface area.

IMPORTANT SAFETY INFORMATION

Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).

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.

See full Prescribing Information and Patient Information.

About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis

ADORING is Dermavant’s pivotal Phase 3 atopic dermatitis (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

Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant is also developing VTAMA cream for the treatment of atopic dermatitis in adults and children as young as 2 years old and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration.

For more information, please visit www.dermavant.com and follow us on X (@dermavant) and LinkedIn (Dermavant Sciences).

For more information, please visit https://www.dermavant.com/and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

©2024 Dermavant Sciences, Inc. All Rights Reserved. Dermavant and VTAMA are the registered trademarks of Dermavant Sciences, GmbH. vIGA-AD is the trademark of Eli Lilly and Co.

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