Dermavant says Vtama topical cream works in PhIII eczema trial

March 15, 2023 09:01 AM EDT Updated 11:04 AM R&D

Kyle LaHucik
Associate Editor

Dermavant Sciences said its plaque psoriasis-approved cream Vtama also worked in patients with atopic dermatitis, as the Roivant subsidiary pushes toward a label expansion of the topical.

In a 406-patient randomized trial, Dermavant said Vtama met the main goal, leading to a statistically significant improvement in an investigator assessment of lesions.

Matt Gline
“These are the fun ones, and we’re really pleased with the update we have to share today,” Roivant CEO Matt Gline said to kick off a Wednesday morning call. He called it the “ninth consecutive positive Phase III study coming out of the Roivant family” and said a supplemental NDA will be shipped to FDA in the first quarter of 2024.

Another identically designed trial will read out in May, the company said, as Dermavant looks to expand the reach of its cream, which has been prescribed more than 110,000 times since the May 2022 approval for adults with plaque psoriasis.

The Long Beach, CA biotech said 46.4% of patients who received the cream achieved the endpoint, showing a clearing or almost clearing of lesions and at least a 2-grade improvement from baseline, as viewed at week 8. The percent of patients on vehicle, the comparator, who achieved the goal was 18%. The P-value was less than 0.0001.

With topical approval, Dermavant looks to bring new standard-of-care to plaque psoriasis patients
Patients aged 2 to 81 were included in the ADORING 2 study, and everyone received the cream at the same dose and dose regimen as the one approved for plaque psoriasis, which is marked by dry, scaly and itchy skin. For every three patients, two received the once-daily Vtama. Most of them, 80.3%, were under 18 years old.

Statistical significance was also met on the test known as EASI75. For patients at least 12 years old, they also saw a reduction in itching.

“I promise you my team and I are racing to bring this innovation and much-needed treatment to patients as fast as we possibly can,” Dermavant CEO Todd Zavodnick said in the call shortly after the data release.

The drug developer said there were no safety or tolerability signals and adverse events were “mild to moderate.” About 1.5% of patients on Vtama and 3% on vehicle left the trial due to adverse events, with 92.4% of patients continuing into a long-term, 52-week safety study of the cream, also known as tapinarof. Zavodnick called that an “extremely high” number that “speaks volumes.”