LONG BEACH, Calif., and BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced it will present data from multiple studies of VTAMA® (tapinarof) cream, 1% at the 2022 Fall Clinical Dermatology Conference from October 20-23 in Las Vegas. The poster presentations at the conference will include data on VTAMA cream for the treatment of plaque psoriasis in adults and atopic dermatitis in patients as young as two.
In May, following more than 25 years of minimal innovation in topical psoriasis treatments, the U.S. Food and Drug Administration (FDA) approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in adults — with no label restrictions on duration of use or body surface area. As of July 15th, VTAMA cream became the #1 prescribed branded topical treatment for plaque psoriasis in adults.i
The first-in-class, steroid-free, once-daily topical treatment is also under investigation for the treatment of atopic dermatitis in adults and children as young as two. The company anticipates announcing topline results from its pivotal Phase 3 clinical trial program in atopic dermatitis (ADORING 1 and ADORING 2) in the first half of 2023.
The following posters will be viewable in-person in the exhibit hall area at the Wynn Hotel in Las Vegas and available virtually at the start of the conference.
Title: Tapinarof Cream 1% Once Daily for the Treatment of Extensive Atopic Dermatitis in Adolescents and Children: 4-Week Maximal Use Trial
This poster details the study design of a 4-week maximal-use trial, which will assess safety, tolerability, pharmacokinetics (PK), and efficacy of tapinarof cream 1% (QD) in adolescents and children with extensive, moderate to severe atopic dermatitis (AD). Baseline patient demographics and disease characteristics are reported.
Authors: Amy Paller, Adelaide A. Hebert, John E. Jett, Philip M. Brown, David S. Rubenstein, Stephen C. Piscitelli
Title: Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Pooled Efficacy from Three Phase 3 Trials
This poster will present the efficacy and safety of tapinarof cream 1% once-daily (QD) using pooled data from three Phase 3 trials (PSOARING 1, PSOARING 2, PSOARING 3), under conditions of continuous or intermittent treatment for up to 1 year.
Authors: Linda Stein Gold, Mark Lebwohl, Robert Bissonnette, Bruce Strober, Anna M. Tallman, Philip M. Brown, Stephen C. Piscitelli, David S. Rubenstein
Title: Exposure–Response Analysis Demonstrates Response to Tapinarof is Driven by Local Effects at Sites of Application
This poster will report the relationship between tapinarof plasma exposure and either safety or efficacy from topical tapinarof application across four clinical trials: a Phase 2b trial in atopic dermatitis (AD); a Phase 2a maximal use trial in plaque psoriasis; and the Phase 3 trials in plaque psoriasis, PSOARING 1 and PSOARING 2.
Authors: James Del Rosso, Scott Guenthner, H. Chih-ho Hong, John E. Jett, Philip M. Brown, David S. Rubenstein, Stephen C. Piscitelli
Title: Treat-to-Target Outcomes and Measures of Treatment Success in Three Phase 3 Trials of Tapinarof Cream 1% Once Daily for Mild to Severe Plaque Psoriasis
This poster will share analyses of treat-to-target outcomes for patients treated with tapinarof cream 1% (QD) in the PSOARING trials, including more-aggressive targets of the proportion of patients achieving an absolute Psoriasis Area Severity Index (PASI) total score of ≤1, ≤2, or ≤3, or a %BSA affected of ≤1% or ≤0.5%.
Authors: April W. Armstrong, Robert Bissonnette, Philip M. Brown, Anna M. Tallman, Kim A. Papp
Title: Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Improvements in Quality of Life and Clinical Efficacy in Two Pivotal Phase 3 Trials
This poster will present further analyses of patient-reported and clinician-assessed outcomes for tapinarof cream 1% QD based on the Dermatology Life Quality Index (DLQI), Physician's Global Assessment (PGA), and Psoriasis Area Severity Index (PASI) in PSOARING 1 and PSOARING 2.
Authors: Linda Stein Gold, Christopher E. M. Griffiths, Anna M. Tallman, Philip M. Brown, Mark G. Lebwohl
For more information about VTAMA (tapinarof) cream, 1%, visit VTAMA.com.
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 fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Dermavant Sciences at 18 DERMAVANT (1-833-762-8268).
See full Prescribing Information and Patient Information at VTAMA.com.
About Psoriasis
Impacting approximately 8 million Americans and 125 million people worldwide, psoriasis is a complex autoimmune disease — meaning that the body’s immune system targets and attacks its own cells. Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 80 to 90% of people with psoriasis. In people with light skin, plaque psoriasis is characterized by raised, red or pink patches of skin with silvery-white scale. People with black or brown skin are more likely to have brown or violet-colored patches with silvery-white or gray scale. The scale can be itchy, painful and disfiguring.
Psoriasis can begin at any age, but typically appears around 15 to 25 years of age. The exact cause of psoriasis is not known, but risk factors and triggers may include genetics or a family history of psoriasis, as well as stress, smoking, heavy alcohol consumption and cold or dry weather conditions. People with psoriasis are at an increased risk of developing other health conditions, including psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. In addition to physical symptoms, psoriasis can have a significant impact on a person’s quality of life and psychological health.
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 early-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. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).
© 2022 Dermavant Sciences, Inc. All rights reserved. All trademarks are the property of Dermavant Sciences, GmbH.
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i IQVIA National Prescription Audit (NPA) as of week 9/9/2022, reflecting estimates of real-world activity. All rights reserved.