Dermavant Announces Publication of ADORING 1 & ADORING 2 Pivotal Phase 3 Trials of VTAMA® (tapinarof) cream, 1% for Adults and Children 2 Years of Age and Older with Atopic Dermatitis in JAAD

— ADORING 1 and ADORING 2 met their primary efficacy endpoints and all secondary endpoints —

— ADORING 1 and ADORING 2 data were included in the sNDA filing for VTAMA cream, 1% in atopic dermatitis, submitted in February 2024 —

Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that the data from ADORING 1 and ADORING 2, two identical, double-blind, randomized, vehicle-controlled pivotal Phase 3 trials of VTAMA® (tapinarof) cream, 1% for adults and children 2 years of age and older with atopic dermatitis (AD) has been published in the Journal of the American Academy of Dermatology.

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 studied in the ADORING Phase 3 development program and the subject of the sNDA submission for AD.

“We are delighted to announce the publication of the pivotal Phase 3 ADORING trial results in the Journal of the American Academy of Dermatology, which further highlight the positive data of VTAMA cream and its potential as a safe and effective non-steroidal topical medication option for both adults and children with atopic dermatitis,” said Philip M. Brown, MD, JD, Chief Medical Officer of Dermavant. “As we have previously announced, we submitted our sNDA application for VTAMA cream for the treatment of atopic dermatitis earlier this year, and subject to FDA approval, we eagerly anticipate bringing VTAMA cream to patients, their caregivers, and the physicians who treat them.”

1. Primary Endpoint: Proportion of patients who achieved a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD^TM) score of clear (0) or almost clear (1) and ≥2-grade improvement from baseline at Week 8.

2. Secondary Endpoint: Proportion of patients with ≥75% improvement in Eczema Area and Severity Index (EASI) from baseline at Week 8.

3. Secondary Endpoint: Proportion of patients ≥12 years old with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score ≥4 who achieved ≥4-point reduction in the PP-NRS from baseline at Week 8.

ADORING 1 (N=407) and ADORING 2 (N=406), two pivotal Phase 3 studies that evaluated the efficacy and safety of VTAMA cream in adults and pediatric patients as young as 2 years old who had a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 (moderate) or 4 (severe) at baseline. In the pivotal trials, VTAMA cream demonstrated highly statistically significant improvement compared to vehicle (both P<0.0001) in achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 8, the primary endpoint. VTAMA cream also demonstrated highly statistically significant improvement in the proportion of patients who achieved ≥75% improvement in the EASI75 from baseline at Week 8 compared to patients on vehicle (both P<0.0001), a key secondary endpoint in the pivotal trials. Patients 12 years of age and older, the population for whom the PP-NRS has been validated, who received VTAMA cream also experienced a statistically significant improvement in itch as assessed by a ≥4-point improvement in the patient reported PP-NRS score compared to patients on vehicle (P=0.0366 for ADORING 1 and P=0.0015 for ADORING 2), another secondary endpoint. VTAMA cream data indicated no new safety or tolerability signals of concern in this population including children 2 years of age and older. Adverse events of special interest included contact dermatitis, follicular events, and headache. Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events.

“The positive data from ADORING 1 and ADORING 2 indicate that VTAMA cream has potential as a new non-steroidal topical treatment for atopic dermatitis, that could be used on any affected area, for both adults and children as young as two years old,” said Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences in Washington, DC., and the Director of Clinical Research and Contact Dermatitis. “In addition, the itch data from ADORING 1 and 2 speaks to VTAMA cream’s potential to reduce one of the disease’s most burdensome symptoms.”

On May 24, 2022, Dermavant announced 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 in adults – with no label safety warnings or precautions, or restrictions on duration of use or body surface area. On February 12, 2024, Dermavant submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VTAMA® (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older.

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 http://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 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, extension trial.

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 has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older 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 http://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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