In fresh threat to Incyte's Opzelura, Dermavant's Vtama cream hits goal in eczema phase 3 study

Incyte’s Opzelura cream may be looking at a new competitive rival in the lucrative atopic dermatitis field.

Wednesday, Dermavant Sciences said its topical drug Vtama has come out successful in the first of two phase 3 studies the company is running in atopic dermatitis.

As William Blair analysts see it, Vtama’s results put it “in reach of Opzelura on efficacy,” although one important data point remains unknown.

In a phase 3 trial called ADORING 2, 46.4% of eczema patients who received the Vtama cream enjoyed clear or almost clear skin at week 8 while demonstrating at least a two-grade improvement from baseline. Vtama’s skin clearance rate was higher than the 18% observed in control patients who got a dummy therapy.

Vtama also aced other secondary endpoints. The topical AHR agonist helped 59.1% of patients experience a 75% reduction from baseline in the Eczema Area and Severity Index (EASI), versus 21.2% in the control arm. It also outperformed the control cream at reducing itching on a scorecard called PP-NRS.

The trial win represents a potential threat to Incyte’s Opzelura, which won FDA approval to treat eczema in September 2021. Last February, Incyte CEO Hervé Hoppenot touted a “very successful” first phase of the launch, with patients quickly taking to the therapy in the final quarter of 2021.

“Overall, results for Vtama look competitive to Opzelura,” William Blair analysts wrote in a Wednesday note.

On the primary endpoint of skin clearance, Vtama’s improvement appeared slightly weaker than what Opzelura showed in its two TRuE-AD trials. But as the William Blair analysts noted, the two drugs’ trial participants were very different. Vtama’s ADORING 2 trial enrolled patients who had higher baseline eczema coverage area with more severe disease, and they were younger.

Vtama’s improvement in the itch endpoint was also numerically lower than Opzelura in its own trial. Still, it was “certainly a more competitive profile than [Arcuits’] Zoryve,” the William Blair team noted. Itch resolution is highly valued among patients, the analysts said. Both Zoryve and Vtama are currently only FDA-approved in plaque psoriasis.

Dermavant’s Wednesday release didn’t include information on the speed of the treatment effect, which the William Blair team said will be important to watch. There, Opzelura showed a fast separation from control as early as two weeks, the analysts noted.

Dermavant is also running a second, identical phase 3 trial, called ADORING 1. The company expects the study to read out in May, chief medical officer Philip Brown, M.D., said in a statement. William Blair expects Vtama could reach the eczema market in the second half of 2024.