LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced it will present data from its ADORING 1 and 2 Pivotal Phase 3 Trials of VTAMA® (tapinarof) cream, 1% at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, to be held from October 11-14, 2023 in Berlin, Germany.
The following late-breaking oral presentations will be presented live during the Late Breaking News sessions on October 11 and October 12, 2023 and will be available on the EADV virtual platform.
Title: Tapinarof Cream 1% Once Daily: Significant Efficacy in the Treatment of Moderate to Severe Atopic Dermatitis in Two Pivotal Phase 3 Trials in Adults and Children Down to 2 Years of Age
Presentation Date and Time: Wednesday, 11 October, 15:30 – 15:45 (GMT+2) (9:30 – 9:45 ET)
Session and Location: D1T01.1: Late Breaking News (Hall B)
This oral presentation will include data on the efficacy and safety of VTAMA® (tapinarof) cream, 1% once daily (QD) in ADORING 1 and 2, including assessment of the Validated Investigator Global Assessment for Atopic Dermatitis™ (vIGA-AD™) response at Week 8, ≥75% Improvement in Eczema Area and Severity Index (EASI75) score, and Peak Pruritus Numeric Rating Scale (PP-NRS) score.
Authors: Jonathan I. Silverberg, Lawrence F. Eichenfield, Adelaide A. Hebert, Eric Simpson, Linda Stein Gold, Robert Bissonnette, Kim A. Papp, John Browning, Pearl Kwong, Neil J. Korman, Philip M. Brown, David S. Rubenstein, Stephen C. Piscitelli, Matthew C. Somerville, Anna M. Tallman, Leon Kircik
Title: Rapid and Early Onset of Itch Relief with Tapinarof Cream 1% Once Daily in Two Pivotal Phase 3 Trials in Adults and Children Down to Two Years of Age with Moderate to Severe Atopic Dermatitis
Presentation Date and Time: Thursday, 12 October, 15:15 – 15:30 (GMT+2) (9:15 – 9:30 ET)
Session and Location: D2T01.3: Late Breaking News (Hall B)
This oral presentation will include data on the efficacy endpoints that evaluated itch relief of VTAMA® (tapinarof) cream, 1% once daily (QD) in ADORING 1 and 2 based on mean daily and mean weekly changes in Peak Pruritus Numeric Rating Scale (PP-NRS) scores through Week 8.
Authors: Eric Simpson, Jonathan I. Silverberg, Robert Bissonnette, Linda Stein Gold, April Armstrong, Adelaide A. Hebert, Rocco T. Serrao, Jeannette R. Jakus, Philip M. Brown, David S. Rubenstein, Stephen C. Piscitelli, Anna M. Tallman, Lawrence F. Eichenfield
VTAMA cream is a first-in-class, steroid free, once-daily, topical treatment that was approved for mild, moderate, and severe plaque psoriasis in adults by the U.S. Food and Drug Administration (FDA) in May 2022. In the two months following approval, VTAMA cream became the #1 prescribed branded topical treatment for plaque psoriasis in adultsi — with more than 200,000 prescriptions written to date and over 11,000 unique prescribers.†
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.
See full Prescribing Information and Patient Information.
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.
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 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.
For more information, please visit www.dermavant.com and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).
© 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.
iIQVIA National Prescription Audit (NPA) for the 3-month period ending 9/22/2023, reflecting estimates of real-world activity. All rights reserved.
†IQVIA NPA for the period 5/20/22 to 9/22/2023, reflecting estimates of real-world activity. All rights reserved.