Roivant Sciences Limited saw its shares rise after its subsidiary Dermavant Sciences reported positive topline results from ADORING 2, one of two Phase 3 studies to evaluate the effectiveness and safety of topical VTAMA (tapinarof) cream.
The Long Beach, California-based biopharma said both adult and pediatric atopic dermatitis (AD) subjects received the VTAMA cream, and 1% received the same dose and dose regimen as the cream is already approved for in adults with plaque psoriasis.
In ADORING 2, VTAMA cream met the main endpoint of the trial and showed statistically significant improvement in the vIGA-AD score of clear or almost clear, with at least a 2-grade improvement from baseline at Week 8 (P<0.0001).
Investors reacted to the news, sending Roivant shares up nearly 9% to $8.67 by midday.
“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 Philip M Brown, the chief medical officer at Dermavant.
Atopic dermatitis is the most common type of eczema, and affects over 9.6 million children and 16.5 million adults in the US.
“The majority of patients diagnosed with AD suffer from severe itching and scratching resulting in skin redness, and damage to the skin barrier, which is why any effective therapeutic for AD needs to tackle the issue of pruritus, especially in a pediatric population,” added Brown. “We now keenly anticipate topline data from our identically designed ADORING 1 trial in May 2023.”
Roivant noted that “meaningful impact” on the key secondary endpoint of pruritus (itch) was demonstrated with 52.8% of subjects ≥12 years old, achieving a ≥4-point reduction in the PP-NRS at Week 8.
On May 24 last year, the US Food and Drug Administration (FDA) approved VTAMA (tapinarof) cream at 1% strength for the treatment of adult plaque psoriasis. The approval made VTAMA cream the first non-steroidal topical cream launched for psoriasis in the US in more than 25 years.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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