– VTAMA cream demonstrated statistically significant efficacy in adults and children down to 2 years of age with atopic dermatitis, in a diverse population comprised of approximately 50% of patients with skin of color –
– In ADORING 1 and ADORING 2, 57.1% and 58.1% of patients, respectively, with Fitzpatrick skin type (IV, V, VI) achieved an EASI75 response at Week 8 –
LONG BEACH, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced new data on treatment of patients with skin of color from its Phase 3, ADORING 1 and ADORING 2 pivotal trials of VTAMA®(tapinarof) cream, 1% in adults and children 2 years of age and older with atopic dermatitis (AD) at the 2024 American Academy of Dermatology (AAD) Annual Meeting, being held from March 8-12 in San Diego, CA.
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.
“The data on treatment of patients with skin of color presented today at the AAD annual meeting is extremely promising, as it highlights VTAMA cream’s ability to achieve consistent and strong efficacy across all racial groups, including patients with skin of color,” said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. “Importantly, approximately 50% of patients who enrolled in the ADORING pivotal trials had skin of color, a particularly high representation in clinical trials. Based on the results we have reported thus far, we are enthusiastic about VTAMA cream’s potential, and if approved by the FDA for atopic dermatitis, we believe that VTAMA cream will make a meaningful difference for the diverse patient population suffering with AD.”
In ADORING 1 (N=407) and ADORING 2 (N=406), two identical, double-blind, randomized, vehicle-controlled, pivotal Phase 3 trials, patients were randomized 2:1 to receive VTAMA cream, 1% QD or vehicle QD for 8 weeks. The primary efficacy endpoint was the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 8. Secondary endpoints in the pivotal studies included the proportion of patients who achieved ≥75% improvement in the Eczema Area and Severity Index (EASI75).
The new data presented at the 2024 AAD annual meeting reports efficacy by patient-reported race categories and investigator-assessed Fitzpatrick skin types among adults and children 2 years of age and older in the pivotal Phase 3 trials of VTAMA cream, 1% QD for the treatment of AD.
Baseline Demographics Across ADORING Pivotal Phase 3 Trials:
- Approximately 50% of patients who enrolled had skin of color.
- Patient demographics across ADORING 1 and ADORING 2: 8.8% – 15.3% were Asian, 26.5% – 35.0% were Black/African American, 2.7% – 5.2% were Other groups (including American Indian, Alaska Native, Native Hawaiian, Pacific Islander, or other/multiple races), and 44.8% – 56.8% were White.
- Patients with Fitzpatrick skin types IV, V, and VI (most representative of populations with skin of color) represented 23.8% – 25.1%, 20.6% – 22.2%, and 7.6% – 8.9% of patients, respectively, across ADORING 1 and ADORING 2.
New Data on VTAMA cream from ADORING 1 and ADORING 2 for the Treatment of AD in Patients with Skin of Color Presented at AAD 2024 – Primary and Secondary Endpoints:
|
ADORING 1 |
||||||
|
|
ASIAN |
BLACK3 |
WHITE |
|||
|
VTAMA cream, 1% QD (n=26) |
Vehicle QD (n=10) |
VTAMA cream, 1% QD (n=70) |
Vehicle QD |
VTAMA cream, 1% QD (n=152) |
Vehicle QD (n=79) |
|
|
Primary Endpoint1 |
39.5% |
3.7% |
47.0% |
17.5% |
49.4% |
12.2% |
|
EASI752 |
47.6% |
20.2% |
55.3% |
30.0% |
61.4% |
19.6% |
|
|
||||||
|
ADORING 2 |
||||||
|
|
ASIAN |
BLACK3 |
WHITE |
|||
|
VTAMA cream, 1% QD (n=39) |
Vehicle QD (n=23) |
VTAMA cream, 1% QD (n=95) |
Vehicle QD (n=47) |
VTAMA cream, 1% QD (n=124) |
Vehicle QD (n=58) |
|
|
Primary Endpoint1 |
48.9% |
18.5% |
43.1% |
24.1% |
52.1% |
14.5% |
|
EASI752 |
76.6% |
17.7% |
48.9% |
25.7% |
67.8% |
20.7% |
1Primary Endpoint: Proportion of patients who achieved a vIGA-AD score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 8.
2Secondary Endpoint: Proportion of patients with ≥75% improvement in EASI from baseline at Week 8.
3Includes Black or African American
Adverse events reported in the ADORING pivotal trials were mostly mild or moderate; the most frequent (≥5% in any group) were folliculitis, headache, and nasopharyngitis.
“Atopic dermatitis is a dermatological condition that can affect people from all racial and ethnic backgrounds and skin types. Treating diverse patients involves recognizing nuances in specific populations, which historically has been hampered by a lack of data for people of color, exacerbated by their underrepresentation in clinical trials,” said Andrew F. Alexis, MD, MPH, Vice-Chair for Diversity and Inclusion for the Department of Dermatology and Professor of Clinical Dermatology at Weill Cornell Medicine and a dermatologist at New York-Presbyterian/Weill Cornell Medical Center. “Today’s data on treatment of patients with skin of color highlight VTAMA cream’s promise across all racial groups and skin types in the pivotal trials. This is an example of innovation that may help clinicians improve the treatment journey for patients with atopic dermatitis.”
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 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 13, 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.
Many physicians and scientists collaborate with external organizations to foster scientific innovation and provide expert guidance. Dr. Alexis serves as a paid consultant and advisory board member for Dermavant.
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, 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 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 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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dna Communications:
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ASalerno-Robin@dna-comms.com
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