LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from its Phase 4, open-label clinical trial of VTAMA® (tapinarof) cream, 1% for the treatment of intertriginous plaque psoriasis, (iPsO) (areas where skin touches or rubs together including the underarms, eyelids, genitals and groin) in adults (n=34) at the 43rd Annual Fall Clinical Dermatology Conference, being held in Las Vegas, NV between October 19-22, 2023.
Intertriginous plaque psoriasis, also known as inverse psoriasis, affects approximately 20%–30% of individuals who have plaque psoriasis. The treatment for plaque psoriasis in intertriginous areas is specifically challenging, because these sensitive areas are more prone to potential adverse effects from existing steroidal-topical treatments. Plaque psoriasis in intertriginous areas has a substantial impact on patients’ health related quality of life (HRQoL), due to itch, pain, and psychological distress.1,2
“Intertriginous plaque psoriasis can be a challenging disease, especially with limited treatment options appropriate for long term use and which may cause potential adverse effects. The data we are sharing today brings an innovative, safe, and effective steroid-free prescription topical treatment to those suffering from, and indeed hardest hit by, this debilitating condition,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Disease improvement is an expectation of psoriasis patients, and we are able to point to meaningful levels of complete disease clearance in highly sensitive intertriginous areas, as this study shows.”
“We are thrilled to share the positive data from our Phase 4 clinical trial of VTAMA cream for the treatment of intertriginous plaque psoriasis in adult patients,” said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. “The results demonstrate that VTAMA cream is efficacious, safe and well tolerated for the treatment of plaque psoriasis in sensitive intertriginous areas, which are consistent with and build upon results from our PSOARING Phase 3 pivotal clinical trials. This Phase 4 trial of VTAMA cream has demonstrated the ability to not only safely address the visible lesions, but also to improve the quality of life because the plaques improved.”
This Phase 4 study expands the body of data for VTAMA cream in adult plaque psoriasis. In the two 12-week Phase 3 pivotal studies (PSOARING 1 and 2; n=1025), VTAMA cream had previously demonstrated a Physician Global Assessment (PGA) success rate* of 36% and 40% for adult patients with plaque psoriasis vs. 6% and 6% for patients on vehicle, respectively. DMVT-505-4001 (NCT05680740) was a Phase 4, open-label multi-center study that evaluated the efficacy and safety of VTAMA (tapinarof) cream, 1% in adults with intertriginous plaque psoriasis (iPsO). The trial enrolled 34 participants with mild, moderate, and severe iPsO (iPGA score ≥2) aged 18 years or older at 7 sites across the U.S. Patients received VTAMA cream once daily for 12 weeks with a follow up one week after study completion. Safety and tolerability were assessed based on adverse events and local tolerability scores using the investigator-assessed Local Tolerability Scale (LTS) of intertriginous areas.
The primary endpoint of the study was the proportion of patients who achieved an iPGA score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12. The secondary endpoint of the study was the time to achieve an iPGA score of 0 or 1 and ≥2-grade improvement from baseline. Key exploratory endpoints of the study included: change in itch as assessed by change in Peak Pruritus-Numeric Rating Scale (PP-NRS) (intertriginous areas) score over time; achievement of ≥4-point reduction in PP-NRS (intertriginous areas) over time; and change in Dermatology Life Quality Index (DLQI) over time.
Phase 4 Results
- VTAMA cream demonstrated compelling efficacy for the treatment of iPsO, including in patients with genital involvement (n=3), with 82.8% of adult patients (n=29) achieving an iPGA Score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12, the primary endpoint of the study.
- VTAMA cream showed a rapid onset of efficacy with iPGA success achieved as early as Week 2 and with a median time to iPGA success of 6 weeks, the secondary endpoint of the study.
- At Week 12, 65.5% of participants achieved complete disease clearance (iPGA=0), with a median time to complete disease clearance of 8 weeks.
- Onset of itch relief was apparent by Week 1 and increased over time with 50% of patients achieving a clinically meaningful >4-point improvement in PP-NRS at Week 4 and 75% at Week 12, by the end of the study.
- Substantial and clinically meaningful improvement in quality of life, as indicated by a 4-point improvement in DLQI, was achieved by Week 2 with further improvement out to Week 12.
- VTAMA cream was well tolerated with no new safety signals.
- The most common adverse reactions in the Phase 4 trial were consistent with the Phase 3 most common adverse reactions. In the two Phase 3 pivotal trials, the most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
“The results of this Phase 4 study are meaningful because patients that entered this study had suffered with extensive disease, many over ten years duration. While the rates of disease clearance are impressive, the fast onset of VTAMA cream and associated itch relief are particularly noteworthy,” said Howard Sofen, MD, of Dermatology Research Associates, and principal investigator for the study. “These data, combined with those of previous studies, further indicate that VTAMA cream is a safe and effective treatment for adult patients with intertriginous plaque psoriasis.”
On May 24, 2022, Dermavant announced that 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. On July 15, 2022, VTAMA cream became the #1 prescribed branded topical treatment for plaque psoriasis in adultsi and to date has over 225,000 prescriptions written with over 12,000 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 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 scales. People with black or brown skin are more likely to have brown or violet-colored patches with silvery-white or gray scales. The scales can be itchy, painful and disfiguring.
Psoriasis can begin at any age, but typically appears around 15 to 25 years of age and 50 to 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 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. All registered trademarks are the property of Dermavant Sciences, GmbH.
- Khosravi H, Siegel MP, Van Voorhees AS, Merola JF. Treatment of Inverse/Intertriginous Psoriasis: Updated Guidelines from the Medical Board of the National Psoriasis Foundation. J Drugs Dermatol. 2017;16(8):760-766.
- National Psoriasis. Intertriginous Psoriasis. Available at: https://www.psoriasis.org/inverse-psoriasis/.
*PGA success: PGA score of 0 or 1 and ≥2-grade improvement from baseline at Week 12.
iIQVIA National Prescription Audit (NPA) for the 3-month period ending 10/6/2023, reflecting estimates of real-world activity. All rights reserved.
†IQVIA NPA for the period 5/20/22 to 10/6/2023, reflecting estimates of real-world activity. All rights reserved.