Roivant stock jumps as skin cream Vtama meets main goal of phase 3 eczema trial

Dermavant Sciences' Vtama cream met the main goal of achieving clearer skin in a phase 3 trial to treat patients as young as two years old, and adults with atopic dermatitis (AD).

Vtama is already approved in the U.S. to treat adults with plaque psoriasis.

The study, dubbed ADORING 2, enrolled 406 children and adults with AD (also known as eczema) and evaluated topical Vtama (tapinarof) cream 1% versus vehicle cream.

Dermavant, a unit of Roivant Sciences (NASDAQ:ROIV), said Vtama met the main goal and showed highly statistically significant improvement in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) skin with at least a 2-grade improvement from baseline, versus vehicle, at week 8.

About 46.4% of patients on Vtama achieved this main goal, compared to 18% on the vehicle cream.

About 59.1 % patients on Vtama achieved >75% improvement (EASI75) compared to 21.2% on placebo, from baseline at week 8. EASI75 was one of the secondary goals of the study.

In addition, 52.8 % of patients 12 years and older receiving Vtama saw improvement of >4-point reduction in Peak Pruritis Numeric Rating Scale (PP-NRS) in itch, compared to 24.1 % of those on vehicle. PP-NRS score ≥4 was another secondary objective.

The company noted that patients with AD receiving Vtama in the trial did so at the same dose and regimen as already approved for adults with plaque psoriasis. If approved by the FDA for AD, this could be a manufacturing and commercial advantage, according to the company.

"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," said Dermavant's Chief Medical Officer Philip Brown.

The company noted that adverse events were mild to moderate with a low study discontinuation rate due to adverse events (1.5% for Vtama, compared to 3% on vehicle).

Adverse events of special interest included contact dermatitis (1.1% Vtama versus 1.5% on vehicle) and follicular event (8.9% Vtama, compared to 1.5% on vehicle).

The company expects topline data from its identically designed another phase 3 study, called ADORING, in May 2023.

ROIV +9.30% to $8.70 premarket March 15