Dermavant Sciences announced that the data from ADORING 1 and ADORING 2 phase 3 trials of Vtama (tapinarof) cream 1% for adults and children 2 years of age and older with atopic dermatitis (AD) has been published in the Journal of the American Academy of Dermatology.
Vtama cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD. Vtama cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the US and is the same strength and formulation studied in the ADORING phase 3 development program and the subject of the sNDA submission for AD.
“We are delighted to announce the publication of the pivotal phase 3 ADORING trial results in the Journal of the American Academy of Dermatology, which further highlight the positive data of Vtama cream and its potential as a safe and effective non-steroidal topical medication option for both adults and children with atopic dermatitis,” Philip M. Brown, MD, JD, Chief Medical Officer of Dermavant, said in a company news release. “As we have previously announced, we submitted our sNDA application for Vtama cream for the treatment of atopic dermatitis earlier this year, and subject to FDA approval, we eagerly anticipate bringing Vtama cream to patients, their caregivers, and the physicians who treat them.”
Table 1: ADORING 1 and ADORING 2 Phase 3 Trials – Primary and Secondary Endpoints | ||||||
ADORING 1 Week 8 | ADORING 2 | |||||
Endpoint | VTAMA cream 1% QD (n=270) | Vehicle QD (n=137) | P Value | VTAMA cream 1% QD (n=271) | Vehicle QD (n=135) | P Value |
vIGA-AD success¹ | 45.4% | 13.9% | <0.0001 | 46.4% | 18.0% | <0.0001 |
EASI75² | 55.8% | 22.9% | <0.0001 | 59.1% | 21.2% | <0.0001 |
≥4-point reduction in PP-NRS³ | 55.8% (n=103) | 34.2% (n=54) | 0.0366 | 52.8% (n=126) | 24.1% (n=64) | 0.0015 |
1. Primary Endpoint: Proportion of patients who achieved a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of clear (0) or almost clear (1) and ≥2-grade improvement from baseline at Week 8.
2. Secondary Endpoint: Proportion of patients with ≥75% improvement in Eczema Area and Severity Index (EASI) from baseline at Week 8.
3. Secondary Endpoint: Proportion of patients ≥12 years old with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score ≥4 who achieved ≥4-point reduction in the PP-NRS from baseline at Week 8.
In the pivotal trials, Vtama cream demonstrated highly statistically significant improvement compared to vehicle (both P<0.0001) in achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 8, the primary endpoint. Vtama cream also demonstrated highly statistically significant improvement in the proportion of patients who achieved ≥75% improvement in the EASI75 from baseline at Week 8 compared to patients on vehicle (both P<0.0001), a key secondary endpoint in the pivotal trials. Patients 12 years of age and older, the population for whom the PP-NRS has been validated, who received Vtama cream also experienced a statistically significant improvement in itch as assessed by a ≥4-point improvement in the patient reported PP-NRS score compared to patients on vehicle (P=0.0366 for ADORING 1 and P=0.0015 for ADORING 2), another secondary endpoint. Vtama cream data indicated no new safety or tolerability signals of concern in this population including children 2 years of age and older. Adverse events of special interest included contact dermatitis, follicular events, and headache. Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events.
On May 24, 2022, Dermavant announced the FDA approved Vtama cream 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.