VTAMA® Cream Phase 3 Results for Atopic Dermatitis in Diverse Skin Tones at 2024 AAD Meeting

Dermavant Sciences, a biopharmaceutical firm, has unveiled promising data on the efficacy of VTAMA® (tapinarof) cream, 1%, for the treatment of atopic dermatitis (AD) in a variety of skin tones. The findings were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, highlighting the cream's effectiveness in both adults and children aged two and above.

VTAMA cream is an innovative aryl hydrocarbon receptor agonist, developed as a daily topical treatment for acute and long-term management of AD, without the use of steroids. It is aesthetically pleasing and has already been approved in the U.S. for the treatment of plaque psoriasis in adults.

The Phase 3 ADORING 1 and ADORING 2 trials, which were pivotal in assessing the cream's impact on skin of color, revealed that more than half of the participants had diverse skin tones. The trials included a significant number of patients with Fitzpatrick skin types IV, V, and VI, which are indicative of darker skin tones. The results showed that a substantial percentage of these patients achieved an EASI75 response, indicating a 75% or more improvement in their condition after eight weeks of treatment.

Dr. Philip M. Brown, Chief Medical Officer at Dermavant, emphasized the importance of these findings, stating that the data is "extremely promising" and demonstrates the cream's consistent efficacy across all racial groups. He also noted the high representation of patients with skin of color in the trials, which is crucial for addressing the unmet needs of this demographic.

The ADORING trials were double-blind, randomized, and vehicle-controlled, with patients receiving either the cream or a placebo for eight weeks. The primary goal was to assess the improvement in the vIGA-AD score, a measure used to evaluate the severity of AD. Secondary endpoints included the proportion of patients achieving an EASI75 response.

The data presented at the AAD meeting detailed the efficacy of the cream based on self-reported race and skin type assessments. The results showed significant improvement in patients across different racial backgrounds, with particularly high response rates in those with darker skin tones.

Dr. Andrew F. Alexis, a dermatologist and advocate for diversity in clinical trials, commented on the importance of these findings for treating AD in diverse populations. He noted the historical lack of data for people of color and the underrepresentation of this group in clinical trials, which has hindered effective treatment for these patients.

Dermavant submitted a Supplemental New Drug Application (sNDA) to the FDA for VTAMA cream for the treatment of AD in both adults and children over two years old. The company is optimistic about the potential of the cream to make a significant difference for patients with AD, should it receive FDA approval.

The safety profile of VTAMA cream was also discussed, with the most common adverse events being mild to moderate, including folliculitis, headache, and nasopharyngitis. Dermavant encourages reporting of any negative side effects to the FDA.

Atopic dermatitis is a widespread inflammatory skin condition affecting millions globally, often causing significant discomfort and impacting quality of life. Dermavant is committed to developing therapies that address the specific needs of diverse patient populations, including those with skin of color.

Dermavant Sciences, a subsidiary of Roivant Sciences, focuses on developing innovative treatments for immuno-dermatology, with a pipeline that includes products for plaque psoriasis, atopic dermatitis, and other immunological and inflammatory diseases. The company's mission is to improve research and clinical development efficiency while meeting high unmet medical needs.