Dermavant Publishes Phase 3 Trials of VTAMA® for Atopic Dermatitis in JAAD

Dermavant Sciences Inc., a biopharmaceutical company specializing in immuno-dermatology, has announced that data from its pivotal Phase 3 trials, ADORING 1 and ADORING 2, have been published in the Journal of the American Academy of Dermatology. These trials examined the efficacy and safety of VTAMA® (tapinarof) cream, 1%, for treating atopic dermatitis (AD) in patients as young as two years old.

VTAMA cream is an innovative, steroid-free, topical treatment designed for both acute and long-term management of AD. It is already approved in the U.S. for treating plaque psoriasis in adults. The same formulation and strength were used in the ADORING Phase 3 studies, and the data from these studies were included in a supplemental New Drug Application (sNDA) submitted to the FDA in February 2024 for expanding its use to include AD.

The ADORING 1 and ADORING 2 trials were double-blind, randomized, vehicle-controlled studies that included 407 and 406 patients, respectively. These trials aimed to assess the effectiveness of VTAMA cream in achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) and a significant improvement from baseline at Week 8.

The results were promising. VTAMA cream showed a highly statistically significant improvement compared to the vehicle in achieving the primary endpoint of a vIGA-AD score of 0 or 1 and a ≥2-grade improvement from baseline at Week 8. Specifically, 45.4% of patients in ADORING 1 and 46.4% in ADORING 2 achieved this primary endpoint with VTAMA cream, compared to 13.9% and 18.0% for those using the vehicle.

Secondary endpoints also demonstrated the cream's effectiveness. In terms of the Eczema Area and Severity Index (EASI75), 55.8% of patients in ADORING 1 and 59.1% in ADORING 2 showed a ≥75% improvement from baseline, compared to 22.9% and 21.2% for the vehicle groups. Additionally, in patients aged 12 and older experiencing significant itch (a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score ≥4), 55.8% in ADORING 1 and 52.8% in ADORING 2 achieved a ≥4-point reduction in the PP-NRS score, versus 34.2% and 24.1% for the vehicle groups.

No new safety or tolerability issues were observed in the trials, making VTAMA cream a promising non-steroidal option for treating AD. Adverse events were generally mild to moderate, with low discontinuation rates due to adverse effects. Some adverse events of special interest included contact dermatitis, follicular events, and headaches.

Jonathan Silverberg, MD, PhD, MPH, emphasized VTAMA cream's potential to address one of AD's most burdensome symptoms—itching. The results from ADORING 1 and 2 indicate that VTAMA cream could become a valuable treatment option for both adults and children with AD.

In addition to the positive outcomes from the ADORING trials, VTAMA cream was previously approved by the FDA for treating plaque psoriasis in adults in May 2022. This approval was significant as it marked the introduction of a new non-steroidal topical therapy for plaque psoriasis in over 25 years.

Dermavant Sciences is focused on developing innovative treatments in immuno-dermatology to address unmet medical needs. The company is actively working on extending VTAMA cream's indications and continues to develop other therapies targeting inflammatory and immunological skin diseases. The recent data from ADORING 1 and 2 add to their growing portfolio and highlight the potential of VTAMA cream in treating atopic dermatitis.