November 8, 2022
– Study demonstrated minimal-to-no systemic exposure despite maximal use –
– Subjects were as young as 2 years old with up to 90% body surface area (BSA) affected and a mean BSA of 43% –
– Maximal usage study utilized same dose of VTAMA cream, 1% currently FDA-approved for adult plaque psoriasis –
LONG BEACH, Calif., and BASEL, Switzerland, November 8, 2022—Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from its maximal usage study of VTAMA® (tapinarof) cream, 1% in children down to age 2 years old with extensive burden of atopic dermatitis.
“We are delighted with the results from our maximal usage study of VTAMA cream, 1% in atopic dermatitis, which for the first time demonstrated highly favorable safety, pharmacokinetics, and clinical improvement in pediatric patients as young as two years of age,” said Philip M. Brown, MD, JD, Chief Medical Officer of Dermavant. “Despite maximal use conditions, in patients with up to 90% body surface area affected, we observed minimal to no systemic exposure, a low incidence of adverse events, and an overall excellent safety profile. In addition, these encouraging results were demonstrated in spite of the skin barrier defect common in atopic dermatitis patients.”
The open label maximal usage study enrolled 36 patients aged 2-17 years old, with an IGA ≥ 3 at screening (mean BSA of 43%, range of 26-90%), for four weeks of treatment with VTAMA cream, 1% QD. The study’s objective was to characterize the pharmacokinetics (PK) and safety of VTAMA cream under maximal usage conditions in pediatric subjects with atopic dermatitis. The maximal usage study of VTAMA cream, 1% utilized the same dose and frequency (1% cream, applied QD) as is being studied in Dermavant’s ongoing ADORING 1 and ADORING 2 pivotal trials for atopic dermatitis. The same dose and frequency for VTAMA cream, 1% has also been approved by the FDA for the topical treatment of adult plaque psoriasis.
VTAMA cream, 1% demonstrated favorable safety, PK and clinical improvement in atopic dermatitis in subjects down to 2 years of age.
These maximal usage pharmacokinetics (MUPK) data will support Dermavant’s anticipated sNDA for atopic dermatitis which will also include results from the company’s ongoing ADORING 1, 2, and 3 phase 3 studies, in subjects aged 2 years old and above. Dermavant believes that having the same 1% topical cream drug product and dosing regimen in the pediatric population will be a key differentiator versus competing programs. The company anticipates announcing topline results from ADORING 1 and ADORING 2 in the first half of 2023.
Dermavant anticipates presenting the full data set from its maximal usage study of VTAMA cream, 1% in atopic dermatitis at a future medical meeting.
On May 24, Dermavant announced that the FDA had approved VTAMA (tapinarof) cream, 1% for the treatment of adult plaque psoriasis. The approval made VTAMA cream, 1% the first topical novel chemical entity launched for psoriasis in the U.S. in more than 25 years. VTAMA cream, 1% is approved for mild, moderate, and severe plaque psoriasis with no label restrictions on duration of use or body surface area. VTAMA cream showed a median remittive “off-treatment” effect of approximately 4 months with durability of response with no evidence of tachyphylaxis (loss of response) while on therapy, as demonstrated for up to 52 weeks in clinical studies.
As of July 15th, VTAMA cream is the #1 prescribed branded topical treatment for plaque psoriasis.1
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.
About Atopic Dermatitis
Atopic Dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affecting over 262 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 30% 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.
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 commercialized, late-stage and earlier-development 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, 1% for the treatment of atopic dermatitis in adults and children and expects to release topline results from its Phase 3 clinical trials in the first half of calendar year 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential differentiated treatment option for immunological and inflammatory diseases with multiple potential routes of administration.
© 2022 Dermavant Sciences, Inc. All Rights Reserved. VTAMA® is the registered trademark of Dermavant Sciences, GmbH.
1. IQVIA National Prescription Audit (NPA) as of week 10/28/2022, reflecting estimates of real-world activity. All rights reserved.