In May of last year, when Dermavant gained its first approval for Vtama (tapinarof), the company’s CEO Todd Zavodnick proclaimed that the topical cream was on its way to changing the standard of care in the treatment of psoriasis.
A year after scoring that FDA green light in plaque psoriasis, Vtama is paving the way for approval in a more game-changing indication—atopic dermatitis.
Dermavant has released data from a phase 3 trial that show Vtama’s effectiveness in adults and children ages 2 and older with eczema. The results from this trial, dubbed ADORING 1, back up and amplify those from ADORING 2, which were released two months ago.
In ADORING 1, which enrolled 407 patients with moderate to severe atopic dermatitis, 45% of those treated with Vtama achieved a score of clear or almost clear and experienced a two-grade improvement on the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scale within eight weeks.
More than three times as many patients on Vtama reached the standard than the 14% who achieved it with a dummy comparator. The trial therefore met its primary endpoint.
The results were a virtual match of those from ADORING 2.
“It’s exciting when you can replicate the primary IGA endpoint,” Zavodnick said in an interview with Fierce Pharma. “It just shows this drug is really predictable.”
Additionally, in ADORING 1, Vtama hit all secondary endpoints with a “high level of statistical significance,” Dermavant said. One of those measures is the Eczema Area and Severity Index. Patients on Vtama were more than twice as likely (56% to 23%) to reach at least a 75% improvement on the scale versus those on the comparator cream.
Vtama also hit the mark on reducing itching and showing minimal to no systemic absorption. Additionally, only 1.9% of participants on Vtama left the trial because of adverse events compared to 3.6% from the placebo group.
How does the once-a-day treatment rank among those who took it in the trials? The company says that 91% have rolled over into ADORING 3, an open-label, long-term safety study.
The company plans to file for approval in eczema in the first quarter of next year, with the hope of reaching the market in the indication in the second half of 2024.
Zavodnick said he came to the Long Beach, California-based private company five years ago because he thought tapinarof—with its unique mechanism of action as an aryl hydrocarbon receptor—could “transform the space.”
It’s an arena that was ready for transformation, Zavodnick added, because it has been dominated for more than three decades by steroidal treatments.
“Being a pharmacist, friends would tell me, ‘I don’t want my kid on a steroid,’” Zavodnick said.
Dermavant is not the first to the market with a non-steroid treatment; Incyte’s Opzelura was approved in September 2021. But as a drug from the JAK inhibitor class, it carries safety concerns and a black box warning on its label.
Vtama has already excelled in its plaque psoriasis indication, becoming the No. 1 branded topical treatment with more than 150,000 prescriptions written by more than 10,000 doctors.
Getting a nod to treat eczema—which has a much larger patient population—could catapult Vtama into a major blockbuster, Zavodnick said.
"This is why I came here when we were looking to build a multibillion-dollar company with Vtama," he added. "I don't think I've slept since Thursday morning when I heard the data."