Dermavant’s VTAMA (tapinarof), a nonsteroidal, topical AhR-modulating agent, achieved positive Phase III trial results in atopic dermatitis patients aged two and above, leading to FDA acceptance of its supplemental new drug application (sNDA). The promising results may bring Dermavant’s VTAMA closer to market authorization and will be its first atopic dermatitis marketed drug, subject to approval, according to GlobalData, a leading data and analytics company.

Tapinarof activates the NRF-2 pathway, modulating type 17 helper T cytokines and inducing antioxidative enzymes, thereby inhibiting inflammatory pathways.

Filippos Maniatis, Healthcare Analyst at GlobalData, comments: “The promising Phase III results for tapinarof marks a milestone for Dermavant, as they bring it one step closer to market authorization for its asset for the treatment of AD patients two years of age and older. However, it needs to be noted that the competition for Dermavant will be high, as there are multiple topical therapies marketed for AD.”

As Dermavant’s VTAMA has been marketed for adult patients with plaque psoriasis (approved in May 2022 by the FDA) its mechanism of action (MoA) may be a promising therapy for AD, with clinical trials showing good tolerance, with minimal adverse effects in patients with AD, hinting at an opportunity for future therapies that may employ a similar mechanism. Tapinarof is a first-in-class molecule that employs the binding of AhR to decrease proinflammatory cytokines, decrease oxidative stress, and promote skin barrier normalization.

According to GlobalData’s Pharmaceutical Intelligence Center, the pipeline landscape for topical treatments against AD includes innovator assets such as Jiangsu Hengrui Medicine’s ivarmacitinib sulfate (China) and Arcutis’s roflumilast (US, Canada), currently in Phase III and pre-registration, respectively.

Other innovator topical pipeline assets include Suzhou Zelgen Biopharmaceutical’s jaktinib hydrochloride, Minghui Pharmaceutical’s MH-004, Maruho’s M-6100, Beijing Puqi Pharmaceutical Technology’s PG-011, Shanghai Thederma Pharmaceuticals’s TAP-1503, and Tianjin Institute of Pharmaceutical Research’s diflucortolone, all of which are in Phase III development.

In addition, GlobalData has estimated tapinarof’s sales to reach $766 million by 2030 globally for AD, subject to approval, showcasing the potential opportunities in the field of AD.

Maniatis concludes: “Although the competition is already high in the pipeline landscape for AD, Dermavant’s tapinarof minimal adverse effects may be a competitive advantage compared to other therapies that are in development.”