Positive ADORING Phase 3 Results for VTAMA® Cream in Treating Pediatric and Adult Atopic Dermatitis

Dermavant Sciences, a biopharmaceutical firm specializing in immuno-dermatology treatments, has reported promising results from their Phase 3 ADORING program. The program evaluated the efficacy and safety of VTAMA® (tapinarof) cream, 1%, for atopic dermatitis (AD) in both adults and children as young as two years old.

The integrated analysis from the ADORING program studies revealed that a significant majority of patients experienced substantial improvement. Specifically, 80.7% of the 711 patients analyzed achieved EASI75, indicating at least a 75% reduction in their disease burden. Notably, 77.9% of patients aged 12 and above, who had a baseline PP-NRS itch score of at least 4, saw a reduction of at least 4 points in their PP-NRS score. Remarkably, a mean reduction in itch was observed within 24 hours of the initial application of the cream.

Furthermore, 73% of the patients achieved a vIGA-AD™ score of 0 (clear) or 1 (almost clear), which represents a significant improvement from their baseline. In an interim analysis of the ADORING 3 study, which is an open-label, long-term extension study, 51.2% of the 728 patients achieved complete disease clearance, as indicated by a vIGA-AD score of 0.

Safety was also a key focus of the study, and the results indicate that VTAMA cream was well-tolerated, with no new safety concerns emerging even after up to 56 weeks of treatment. The discontinuation rate due to adverse events was low at 2.6%, and the most commonly reported adverse events were mild to moderate in nature.

Dermavant's Chief Medical Officer, Philip Brown, highlighted the significance of these findings, stating that the high efficacy rates and the absence of new safety signals support the potential of VTAMA cream as a long-term disease control option. The company is encouraged by the data and is preparing to submit a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2024.

Eric Simpson, a dermatology professor and director of the CLEAR Eczema Center, emphasized the importance of these results, especially for pediatric patients who are most frequently affected by AD. He noted that the high efficacy and safety profile of VTAMA cream could offer a much-needed treatment option for patients, caregivers, and healthcare professionals.

Dermavant's CEO, Todd Zavodnick, expressed gratitude to all involved in the ADORING program and reiterated the company's commitment to making VTAMA cream available to patients as soon as possible, pending regulatory approval.

VTAMA cream is already approved for the treatment of plaque psoriasis in adults in the U.S., marking a significant advancement in non-steroidal topical treatment options for the condition. The cream's approval for AD could further expand its utility and provide relief to millions suffering from this common skin condition.