Dermavant’s ADORING 2 phase 3 trial met all primary and secondary endpoints.
Dermavant Sciences recently announced new positive topline results from its ADORING 2 (NCT05032859) phase 3 clinical trial evaluating the safety and efficacy of once daily (QD) tapinarof (Vtama) cream, 1% in adults and children down to 2 years of age with atopic dermatitis.1 Out of 406 patients, 46.4% receiving tapinarof cream achieved the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response of clear (0) or almost clear (1) with an at least 2-grade improvement from baseline at week 8 compared to 18% on vehicle.
Pediatric and adult patients with atopic dermatitis were randomized at a 2:1 ratio to receive QD tapinarof or vehicle cream. Topline results from ADORING 2 include:
Pending approval from the US Food and Drug Administration (FDA), Dermavant believes tapinarof cream could be a crucial “manufacturing, supply chain, and commercial advantage, offering simplicity of treatment to both physicians, pharmacists, and patients, regardless of diagnosis.”1
Philip M. Brown, MD, JD, and chief medical officer of Dermavant noted that topline data from the identically designed ADORING 1 trial (NCT05014568) is expected in May 2023. Dermavant’s ADORING 3 (NCT05142774) clinical trial, a long term, open-label study is currently recruiting and is expected to conclude in September 2024.
Tapinarof cream was approved by the FDA in May 2022 for the treatment of plaque psoriasis in adult patients. The 2022 FDA approval made tapinarof the first non-steroidal topical novel product for psoriasis available in the United States in over 2 decades.