Dermavant Shares Findings on Itch and Sleep Improvement in Young Atopic Dermatitis Patients at ACAAI Meeting

Dermavant Sciences, a biopharmaceutical company, has recently presented promising data at the American College of Allergy, Asthma and Immunology Annual Meeting. This data is derived from their Phase 3 trials, ADORING 1 and ADORING 2, which investigated the efficacy of VTAMA® (tapinarof) cream, 1%, in treating patients with moderate to severe atopic dermatitis, including young children from the age of two.

The research involved 813 participants, both adults and children, who were randomized to receive either VTAMA cream or a vehicle for a period of eight weeks. The primary objective was to achieve a significant improvement in skin condition, measured by the Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score, and to reduce the severity of itch and sleep disturbances.

Results from these trials were noteworthy. In ADORING 1, 31.4% of those treated with VTAMA cream achieved no-to-minimal itch at Week 8, compared to 17.4% of those in the vehicle group, with statistical significance observed from Week 1. Similarly, in ADORING 2, 33.0% of VTAMA-treated patients reached this itch-free state versus 14.0% in the vehicle group. Additionally, the cream demonstrated significant improvements in sleep for patients aged 2-11 and those aged 12 and above, with statistical significance marked as early as the first week of treatment.

The ADORING trials also indicated that 45% and 46% of patients on VTAMA cream reached the vIGA-AD success definition, compared to 14% and 18% on the vehicle in ADORING 1 and ADORING 2 respectively. This success was defined by achieving a score of 0 or 1 on the vIGA-AD scale, along with a minimum two-grade improvement from baseline.

VTAMA cream was well-tolerated among participants, with the most common adverse reactions being folliculitis, nasopharyngitis, headache, asthma, and influenza. These reactions occurred in at least 1% of the patients treated with the cream.

Dr. Eric Simpson, a renowned dermatologist, emphasized the significance of these findings, highlighting the early and meaningful relief from itch and sleep disturbances that VTAMA cream provided. He noted that itch is a particularly troubling symptom for atopic dermatitis sufferers, often leading to disrupted sleep, which can be especially challenging for young patients and their families.

The Phase 3 program for VTAMA cream, under the name ADORING, includes two pivotal studies (ADORING 1 and ADORING 2) and a long-term extension study (ADORING 3), which spans 48 weeks. These trials aim to establish VTAMA cream as a viable treatment for atopic dermatitis, pending FDA approval.

Atopic dermatitis, also known as eczema, is a prevalent inflammatory skin condition affecting over 26 million individuals in the United States and up to 10% of adults globally. It is especially common among children, impacting up to 20% worldwide. The disease manifests as itchy, red, swollen, and cracked skin, frequently appearing in areas such as the folds of the arms, the back of the knees, hands, face, and neck. The persistent itching often worsens at night, causing significant sleep disturbances and fatigue, which can affect children's concentration at school and lead to social and emotional distress.

Dermavant Sciences is committed to addressing high unmet medical needs through innovative therapeutic solutions. Their current pipeline includes treatments for conditions such as plaque psoriasis and atopic dermatitis. VTAMA cream, which received FDA approval in May 2022 for the treatment of plaque psoriasis, is now being developed for atopic dermatitis in both adults and children over the age of two.

The future looks promising for VTAMA cream as an effective treatment option for atopic dermatitis, offering hope for improved quality of life for patients suffering from this chronic condition.