ROIV - Roivant stock rises after Vtama meets main goal of 2nd phase 3 eczema study

2023-05-16 07:39:45 ET

Dermavant Sciences' Vtama cream met the main goal of achieving clearer skin in a second phase 3 trial to treat adults and pediatric patients down to 2 years old with moderate to severe atopic dermatitis (AD).

The trial, dubbed ADORING 1, enrolled 407 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 by showing highly statistically significant improvement in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at week 8.

About 45.4% of patients on Vtama achieved the main goal, compared to 13.9% on the vehicle cream.

About 55.8% patients treated with Vtama achieved >75% improvement in the Eczema Area and Severity Index (EASI75) compared to 22.9% on vehicle, at week 8. EASI75 was a secondary goal of the trial.

The company added that 55.8% of patients ?12 years old, with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score ?4, achieved a ?4-point reduction in the scale at week 8.

PP-NRS is a self?reported item to measure worst itch.

Across the entire Vtama treated population, 61.1% experienced a statistically significant improvement in itch, according to the company.

Dermavant noted that adverse events included contact dermatitis (1.5% Vtama verus 2.2% vehicle) and follicular event (10% Vtama verus 0.7% vehicle).

"Similar to our ADORING 2 data , VTAMA hit all its primary and secondary endpoints. Subject to FDA approval, we believe that the positive safety and efficacy profile of VTAMA, combined with its treatment simplicity, has the potential to change the approach in the way patients are treated," said Philip Brown, chief medical officer, Dermavant.

The study, dubbed ADORING 2, had met its main goal and the results were announced in March.

The company expects to file for approval of Vtama in atopic dermatitis in the U.S. in Q1 2024. The drug is already approved in the U.S. to treat adults with plaque psoriasis.

ROIV +3.61% to $9.48 premarket May 16

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