Dermavant Presents ADORING 3 LTE Final Data on Complete Skin Clearance and Treatment-Free Interval for VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as Two Years[...]

- The majority of patients, 51.9% (378/728), entered with or achieved complete disease clearance (vIGA-AD™=0) in the 48-week ADORING 3 open-label LTE study. -

- Most patients, 81.6% (594/728), entered with or achieved clear or almost clear skin (vIGA-AD=0 or 1) with VTAMA cream, 1% in the ADORING 3 open-label LTE study. -

- Patients who achieved complete disease clearance (n=378) were able to discontinue VTAMA cream, 1% and remain treatment-free for an average of ~80 consecutive days.-

- FDA PDUFA Action Date for Topical Treatment of Atopic Dermatitis with VTAMA cream
is Expected in Q4 2024. -

LONG BEACH, Calif., and BASEL, Switzerland, October 25, 2024 - Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced data from the ADORING 3 open-label, long-term extension study demonstrating complete skin clearance rates and treatment-free interval at the 44^th Annual Fall Clinical Dermatology Conference, for VTAMA cream, 1% in adults and children as young as two years old with atopic dermatitis (AD).

"In the ADORING long-term extension study, VTAMA cream demonstrated a high rate of complete disease clearance, with more than half of enrolled adults and children entering with or achieving a vIGA-AD score of zero at least once, on monotherapy" said Robert Bissonnette, MD, FRCPC, Chief Executive Officer at Innovaderm Research. "Moreover, upon reaching complete disease clearance and ceasing treatment, patients stayed clear or almost clear for an average period of approximately 80 consecutive days. These results, combined with those from the ADORING 1 and ADORING 2 pivotal studies, demonstrate VTAMA cream's potential ability to not only effectively and safely treat patients as young as 2 years of age with atopic dermatitis, but may also enable a majority to achieve complete disease clearance, and maintain either clear or almost clear skin for an average of over 2 and a half months while off all treatment."

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 as young as 2 years old with AD who had a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 (moderate) to 4 (severe) at baseline. ADORING 3, a 48-week open-label, long-term extension (LTE) study, enrolled eligible patients from ADORING 1, ADORING 2, a 4-week maximal usage pharmacokinetics study, and VTAMA cream-naive patients aged 2-17 years with either mild, moderate or severe AD that did not meet inclusion in ADORING 1 and ADORING 2.

In ADORING 3, patients were followed for up to 48 weeks, with safety and tolerability endpoints that included treatment emergent adverse events, adverse events of special interest, investigator-assessed and patient/caregiver-assessed local tolerability, and efficacy endpoints that included the achievement of complete disease clearance (vIGA-AD=0), and the achievement of clear or almost clear skin (vIGA-AD=0 or 1). Patients entering with any disease activity (vIGA-AD≥1) were treated with VTAMA cream, 1% until complete disease clearance was achieved (vIGA-AD=0). Those entering with or achieving complete clearance (vIGA-AD=0) discontinued VTAMA cream, 1% and were followed to measure the treatment-free interval, defined as the maintenance of clear or almost clear skin (vIGA-AD=0 or 1) for consecutive days while no longer receiving any treatment for AD. Patients whose AD returned to mild or above (vIGA-AD≥2) were re-treated until complete disease clearance (vIGA-AD=0) was achieved again. ADORING 3 reinforced the safety and tolerability of VTAMA cream, 1% demonstrated in ADORING 1 and ADORING 2.

ADORING 3 LTE Skin Clearance and Other Results:

• 728 patients enrolled in ADORING 3; of which 83.0% were pediatric patients (2-17 years) proportionally balanced across defined pediatric age groups.
• Overall, 51.9% (378/728) of patients entered with or achieved complete disease clearance (vIGA-AD=0) at least once during the 48-week study, while 81.6% (594/728) entered with or achieved clear or almost clear skin (vIGA-AD=0 or 1) at least once during the 48-week study.
• After entering with or first achieving complete disease clearance and discontinuing VTAMA cream, 1% treatment (n=378), the average duration of the first treatment-free interval was 79.8 consecutive days (with a standard deviation of 81.4 days).
• After achieving vIGA-AD=0 and discontinuing VTAMA cream, 1%, patients whose vIGA-AD returned to ≥2 (mild or above) off-treatment could regain vIGA-AD=0 when re-treated.
• No evidence of tachyphylaxis (loss of response) in patients receiving either continuous or intermittent therapy of VTAMA cream, 1% was observed for up to 48 weeks.
• Most treatment-emergent adverse events (TEAEs) were mild or moderate; the most frequent were folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%). Study discontinue rate due to TEAEs were low (2.6%).
• Adverse events of special interest (AESI), follicular events, contact dermatitis, and headache were mostly mild or moderate and associated with low study discontinuation rates (1.0%, 0.4%, and 0% respectively). There was no study discontinuation due to headache.
• VTAMA cream, 1% was well tolerated, even when applied to affected sensitive skin areas, including the face (n=374) and neck (n=398).

VTAMA cream, 1% is a novel, aryl hydrocarbon receptor agonist in development in the U.S. 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. In April 2024, the U.S. Food and Drug Administration (FDA) accepted the company's Supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1% for the topical treatment of AD in adults and children 2 years of age and older. The Prescription Drug User Fee Act ("PDUFA") action date assigned by the Agency is in Q4 2024.

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 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.

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.

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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dna Communications:
Jillian Parker
Account Director, Media Relations, Healthcare
[email protected]
732-501-2624

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