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February 13, 2023
– ADORING 1 and 2 trials evaluating VTAMA cream in atopic dermatitis fully enrolled, with topline data expected from the first study in March 2023 and the second study in May 2023 –
– Dermavant recently published highly favorable results from a pediatric maximal usage (MUPK) study of VTAMA cream in atopic dermatitis (AD) demonstrating minimal-to-no-systemic exposure in subjects as young as 2 years old with up to 90% BSA affected with a mean BSA of 43% –
LONG BEACH, Calif., and BASEL, Switzerland, February 13, 2023 — Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that it has completed patient enrollment in its ADORING 1 and 2 Phase 3 clinical trials of VTAMA (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) 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, steroid-free and cosmetically elegant topical cream for the treatment of AD. In the U.S., VTAMA cream is approved for the topical treatment of plaque psoriasis in adults – with no label safety warnings or precautions, restrictions on duration of use or body surface area. Dermavant is developing VTAMA cream for atopic dermatitis using the same dose and regimen already FDA-approved for plaque psoriasis.
“We are delighted to have completed enrollment in our ADORING 1 and 2 Phase 3 pivotal trials of VTAMA in atopic dermatitis, a chronic inflammatory skin condition with significant unmet medical need, especially in children,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “The potential expansion of our VTAMA franchise to include atopic dermatitis represents a major growth opportunity for Dermavant, as plaque psoriasis and atopic dermatitis represent the two largest markets in immuno-dermatology. We are excited about the potential for VTAMA cream to be a novel and highly differentiated treatment option for patients as young as 2 years old who suffer from atopic dermatitis. We’re encouraged by the progress we are making in our ADORING program and look forward to sharing the topline results from both Phase 3 studies in the first half of 2023.”
Dermavant recently published highly favorable results from a pediatric maximal usage pharmacokinetics (MUPK) study of VTAMA cream in atopic dermatitis. The study demonstrated minimal-to-no systemic exposure despite maximal use. In addition, subjects were as young as 2 years old with up to 90% body surface area (BSA) affected with a mean BSA of 43%.
On May 24, 2022, Dermavant announced that the FDA had approved VTAMA (tapinarof) cream, 1% for the treatment of adult plaque psoriasis. The approval made VTAMA cream the first 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 with no restrictions on duration of use or body surface area, as demonstrated up to 52 weeks in the open-label, long-term extension study, and with a demonstrated median remittive “off-treatment” effect of approximately 4 months. Durability of response up to 52 weeks was demonstrated with intermittent use of VTAMA cream, with no evidence of tachyphylaxis (loss of response) while on therapy. As of July 15, 2022, VTAMA cream is the #1 prescribed branded topical treatment for plaque psoriasis.i
About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis
Dermavant’s pivotal Phase 3 clinical program for VTAMA (tapinarof) cream, 1% in atopic dermatitis consists of two identical pivotal trials (ADORING 1 and ADORING 2), followed by an open-label, long-term extension study (ADORING 3).
ADORING 1 and ADORING 2 are two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies being conducted in North America. The Phase 3 clinical program enrolled 813 patients across the two pivotal trials to evaluate the safety and efficacy of VTAMA cream, 1% dosed once daily (QD) for 8 weeks versus vehicle cream QD in patients aged 2 years and older diagnosed with moderate to severe AD. The primary endpoint of both clinical trials is the percentage of patients achieving a vIGA-AD™ (Validated Investigator Global Assessment for Atopic Dermatitis) of 0 or 1 with at least a 2-grade improvement from baseline at week 8.
ADORING 3 is a long-term, open-label, extension study to evaluate the safety and efficacy of VTAMA cream, 1% in patients with AD. The trial includes eligible patients who have completed treatment with VTAMA cream or vehicle in Phase 3 trials. ADORING 3 consists of up to 48 weeks with treatment of VTAMA cream, 1%, and a 7-day safety follow-up period.
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).
About Atopic Dermatitis
Atopic Dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affecting over 28 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 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.
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1 IQVIA National Prescription Audit (NPA) as of week 1/20/2023, reflecting estimates of real-world activity.
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