Dermavant to Present Data from Multiple Studies of VTAMA® (tapinarof) cream, 1% at the 2023 Winter Clinical Dermatology Conference
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 this year.
Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that data from multiple studies of VTAMA®(tapinarof) cream, 1%, will be presented at the 20th Annual Winter Clinical Dermatology Conference, to be held January 13 to 18 in Hawaii.
In 2022, following 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 safety warnings or precautions, restrictions on duration of use or body surface area, and a demonstrated OFF-treatment effect seen in a long-term, open-label extension study (median time to first sign of worsening [PGA>=2] was 114 days). VTAMA cream is the #1 prescribed branded topical treatment for plaque psoriasis in adults.1
The first-in-class, steroid-free, once-daily topical treatment is also under clinical investigation for the treatment of atopic dermatitis in adults and children as young as two years old. 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 this year.
The following posters will be on display in the Grande Ballroom at the Fairmont Orchid Hotel, as well as digitally throughout 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 will detail the study design of a 4-week maximal-use trial of VTAMA cream, which assessed safety, tolerability, and pharmacokinetics in adolescents and children with extensive moderate to severe atopic dermatitis. 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: Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase 3 Trials in Adults with Mild to Severe Plaque Psoriasis
This poster will include adult patient-reported itch outcomes from the PSOARING 1 and PSOARING 2 clinical trials of VTAMA cream for the treatment of plaque psoriasis in adults.
Authors: Leon Kircik, Matthew Zirwas, Shawn G. Kwatra, G. Michael Lewitt, Holly Glover, Tomas Chao, Philip M. Brown, David S. Rubenstein, Anna M. Tallman
Title: Tapinarof Inhibits the Formation, Cytokine Production, and Persistence of Resident Memory T Cells In Vitro
This poster will include an analysis characterizing the in vitro effects of tapinarof on resident memory T-cells which may contribute to the remittive effects observed in clinical studies of VTAMA cream. The specific mechanisms by which VTAMA cream exerts is therapeutic action in psoriasis and atopic dermatitis are unknown.
Authors: Nathan Mooney, Jessica E. Teague, Ahmed E. Gehad, Kimberly McHale, David S. Rubenstein, Rachael A. Clark
Title: Tapinarof Cream 1% Once Daily: Disease Control Off Treatment and Minimal Disease Activity Through End of Remittive Period in a 1-year Trial
In this poster, an analysis of PSOARING 3 evaluating psoriatic disease activity and quality of life at the end of the off-therapy remittive period in adult patients treated with VTAMA cream once-daily (QD) will be presented.
Authors: Bruce Strober, Joshua A. Zeichner, Seemal R. Desai, Michael Cameron, Jennifer Cather, Matthew J. Bruno, David S. Rubenstein, Anna M. Tallman, Philip M. Brown
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 include analyses of treat-to-target outcomes for adult patients treated with VTAMA cream (QD) in the PSOARING trials, including more aggressive targets such as the proportion of those patients achieving an absolute Psoriasis Area Severity Index (PASI) total score of ≤1 or a percent body surface area affected of ≤0.5%.
Authors: April W. Armstrong, Robert Bissonnette, Philip M. Brown, Anna M. Tallman, Kim A. Papp
Title: Exposure–Response Analysis Demonstrates Response to Tapinarof is Driven by Local Effects at Sites of Application
This poster will detail the relationship between VTAMA cream plasma levels and safety and efficacy across four clinical trials: a Phase 2b trial in atopic dermatitis; a Phase 2a maximal use trial in plaque psoriasis; and the Phase 3 PSOARING 1 and PSOARING 2 trials in plaque psoriasis.
Authors: James Del Rosso, Scott Guenthner, H. Chih-ho Hong, John E. Jett, Philip M. Brown, David S. Rubenstein, Stephen C. Piscitelli
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 adult patient-reported and clinician-assessed outcomes for VTAMA cream in plaque psoriasis based on the Dermatology Life Quality Index, Physician's Global Assessment, and 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 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 1-8 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 and 50-60 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 Atopic Dermatitis
Atopic Dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affecting over 262 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 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).
© 2023 Dermavant Sciences, Inc. All rights reserved. All trademarks are the property of Dermavant Sciences, GmbH.
1 IQVIA National Prescription Audit (NPA) as of week 12/23/2022, reflecting estimates of real-world activity. All rights reserved.
2https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/
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