Phase 3 Data: Dermavant's VTAMA Cream Performs Well in Adults and Kids with AD

In the U.S., VTAMA cream is already approved for the topical treatment of plaque psoriasis in adults.

Dermavant’s VTAMA (tapinarof) performed well in kids as young as 2 and adults with atopic dermatitis, according to topline results from the ADORING 2 Atopic Dermatitis Phase 3 Trial. 

VTAMA cream is a novel, aryl hydrocarbon receptor agonist, in development as a once-daily, steroid-free, and cosmetically elegant topical cream for the treatment of AD. In the U.S., VTAMA cream is already approved for the topical treatment of plaque psoriasis in adults.

In ADORING 2, pediatric and adult subjects with atopic dermatitis were randomized at a 2:1 ratio to receive once daily (QD) treatment with VTAMA cream, 1% or vehicle cream. Fully 46.4 percent of subjects receiving VTAMA cream, 1% achieved the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 18.0% on vehicle. What’s more, all secondary endpoints were met with a high degree of statistical significance, including 59.1% of subjects treated with VTAMA cream who achieved the key secondary endpoint of EASI75. 

Subjects 12 years and older receiving VTAMA cream also experienced a highly statistically significant improvement >4-point reduction in Peak Pruritis Numeric Rating Scale (PP-NRS) in itch (P=0.0015), another key secondary endpoint in the study due to its prevalence among AD sufferers.

There have been no safety or tolerability signals in this population including children as young as 2 years old. Adverse events were mild to moderate with a low study discontinuation rate due to adverse events (1.5% VTAMA vs. 3.0% vehicle). Adverse events of special interest included contact dermatitis (1.1% VTAMA vs. 1.5% vehicle) and follicular event (8.9% VTAMA vs. 1.5% vehicle.

Dermavant recently released highly favorable results from a pediatric maximal usage pharmacokinetics (MUPK) study of VTAMA cream in AD. The study demonstrated minimal-to-no systemic exposure despite maximal use. In addition, subjects were as young as 2 years old with up to 90% body surface area (BSA) affected with a mean BSA of 43 percent.

Both adult and pediatric AD subjects receiving VTAMA cream, 1% did so at the same dose and dose regimen as already approved for adults with plaque psoriasis. Subject to FDA approval in AD, the company believes this could be a key manufacturing, supply chain, and commercial advantage, offering simplicity of treatment to both physicians, pharmacists, and patients, regardless of diagnosis.

“We are highly encouraged by the positive results from ADORING 2, which suggests VTAMA cream can be a potentially important non-steroidal, topical treatment option for atopic dermatitis patients, including children as young as two years old where we know there is a compelling need,” says Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant, in a news release. “Atopic dermatitis, the most common type of eczema, affects more than 9.6 million children and 16.5 million adults in the United States. The majority of patients diagnosed with atopic dermatitis suffer from severe itching and scratching resulting in skin redness, and damage to the skin barrier, which is why any effective therapeutic for AD needs to tackle the issue of pruritus, especially in a pediatric population.** We now keenly anticipate topline data from our identically designed ADORING 1 trial in May 2023.”

“Atopic dermatitis can have a negative impact on the quality of life of diagnosed children as well as their families. Both the efficacy and itch data from the ADORING 2 trial are highly encouraging in this regard, pointing to VTAMA cream as a potential non-steroidal topical treatment option for AD that is safe and well tolerated in children,” says Lawrence Eichenfield, M.D. Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego. “Importantly, the potential to use the same dose regimen with VTAMA cream for children and adults with AD offers treatment simplicity for prescribers, helped even more by the fact that it is the same regimen already being used for plaque psoriasis.”

“The topline results from ADORING 2 underscore VTAMA cream as a potential well-tolerated therapeutic with a favorable safety profile,” says Linda Stein Gold, M.D., Director of Clinical Research and the Division Head of Dermatology at the Henry Ford Health System. “When one considers this Phase 3 data alongside the recently reported pediatric maximal usage pharmacokinetic (MUPK) AD study, which in treated patients demonstrated minimal-to-no-systemic exposure despite heavy disease burden, VTAMA cream is positioning itself to be a potential two-in-one first-line topical treatment for both atopic dermatitis and plaque psoriasis.”