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October 12, 2023
– New ADORING 1 and ADORING 2 Phase 3 data show a rapid reduction in pruritus (itch) as early as 24 hours after first application of VTAMA cream –
– Consistent improvement in itch with VTAMA cream increased through Week 8 –
– sNDA for VTAMA cream in atopic dermatitis anticipated to be filed with the FDA in Q1 2024 –
LONG BEACH, Calif., and BASEL, Switzerland, October 12, 2023 – Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced new pruritus data for VTAMA cream from its two pivotal Phase 3 trials, ADORING 1 and ADORING 2 in adults and children down to two years of age with moderate to severe atopic dermatitis at the European Academy of Dermatology and Venereology (EADV) Congress, being held in Berlin, Germany between October 11-14.
“The new pruritus data presented today at the EADV Congress is extremely encouraging, as it highlights VTAMA cream’s ability to reduce itch, the most prevalent symptom of atopic dermatitis, as early as 24 hours after the first application in some adults and children as young as 2 years old,” said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. “We are truly excited about VTAMA cream’s potential and remain committed to bringing this steroid-free, topical treatment to the forefront as an option for the millions of patients suffering from atopic dermatitis.”
In ADORING 1 (N=407) and ADORING 2 (N=406), two identical, double-blind, vehicle-controlled trials, patients were randomized 2:1 to tapinarof cream 1% QD or vehicle QD for 8 weeks. Patients with a Validated Investigator Global Assessment for Atopic Dermatitis™(vIGA-AD™) score of ≥3, an Eczema Area, and Severity Index (EASI) score of ≥6, and body surface area involvement of 5–35% were included. The efficacy endpoints that evaluated itch relief included mean changes in Peak Pruritus-Numeric Rating Scale (PP-NRS) score (daily and by visit [Weeks 1, 2, 4, and 8]) from baseline through Week 8. The PP-NRS considers a person’s worst itch over the past 24 hours, assessed on an 11-point scale (0 indicates “no itch” and 10 indicates “worst imaginable itch”).
The new data presented at EADV 2023 contains daily recorded PP-NRS scores of patients in ADORING 1 and ADORING 2 on VTAMA cream for the first time. Daily PP-NRS scores were recorded in patient diaries. Patients aged ≥12 years old self-completed the PP-NRS, while caregivers completed it for children aged <12 years old. At baseline, mean overall PP-NRS scores were 6.7 and 6.8 in ADORING 1 and ADORING 2, respectively.
New VTAMA cream Pruritus Data Presented at EADV 2023:
“Itch remains the most burdensome symptom of atopic dermatitis, negatively impacting the quality of life of not only the patients but also their families,” said Eric Simpson, MD, MCR, the Frances J. Storrs Medical Dermatology Professor and Director of CLEAR Eczema Center, at the Oregon Health & Science University. “Today’s newpruritus data, combined with the initial Phase 3 data, suggest that if approved, VTAMA cream has the potential to change the treatment paradigm for adults and children being treated for atopic dermatitis through disease control and symptom reduction capabilities.”
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 – with no label safety warnings or precautions, restrictions on duration of use or body surface area.
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 Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis
ADORING is Dermavant’s pivotal Phase 3 atopic dermatitis (AD) clinical 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, affecting 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 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 as young as 2 years old and released positive topline results from its ADORING 1 and 2 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 differentiated treatment option for immunological and inflammatory diseases with multiple potential routes of administration.
© 2023 Dermavant Sciences, Inc. All Rights Reserved. VTAMA® is the registered trademark of Dermavant Sciences, GmbH. vIGA-AD™ is the trademark of Eli Lilly and Co.
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