More Phase 3 Data: Dermavant’s VTAMA Hits Primary and Secondary Endpoints for Kids and Adults with AD

VTAMA demonstrated highly statistically significant improvement in the Validated Investigator Global Assessment for Atopic Dermatitis at week 8.

Dermavant Sciences’ VTAMA performed well in in adults and kids with atopic dermatitis, according to topline results from ADORING 1, the company’s second atopic dermatitis (AD) Phase 3 trial.

VTAMA is a novel, aryl hydrocarbon receptor agonist, in development as a once-daily, steroid-free, and cosmetically elegant topical cream for the treatment of AD. In the U.S., VTAMA is currently approved for the topical treatment of plaque psoriasis in adults.

In ADORING 1 (N=407), VTAMA met the primary endpoint of the trial and demonstrated highly statistically significant improvement in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADT) score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8.

Additionally, VTAMA demonstrated highly statistically significant improvement in the proportion of subjects with ≥75% improvement in the Eczema Area and Severity Index (EASI75) from baseline at Week 8), a key secondary endpoint. Subjects 12 years and older receiving VTAMA also experienced a statistically significant improvement in itch with a ≥4-point reduction in the patient reported Peak Pruritus Numeric Rating Scale (PP-NRS), another key secondary endpoint.

Importantly, when PP-NRS was assessed across the entire VTAMA treated population, 61.1% experienced a statistically significant improvement in itch.

Both adult and pediatric AD subjects down to 2 years of age receiving VTAMA in the ADORING trials did so at the same dose and dose regimen as currently approved for adults with plaque psoriasis. Subject to FDA approval in AD, the company believes this could be a key manufacturing, supply chain, and commercial advantage, offering simplicity of treatment to patients, physicians, pharmacists, and payers, regardless of plaque psoriasis or atopic dermatitis diagnosis.

“I am extremely proud to share the positive results from ADORING 1, the second of our two Phase 3 pivotal trials with VTAMA in adults and children as young as 2 years old with moderate to severe atopic dermatitis,” says Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant, in a news release. “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. The success of the ADORING studies marks a significant milestone for the entire Dermavant team, and I would like to extend my heartfelt thanks to the patients and investigators involved in our clinical studies.”

Topline Results

In ADORING 1, adult and pediatric subjects down to 2 years of age with moderate to severe AD were randomized at a 2:1 ratio to receive once daily (QD) treatment with VTAMA or vehicle cream.

• At Week 8, 45.4% of subjects treated with VTAMA in ADORING 1 achieved the primary endpoint of a vIGA-AD of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8.
• Also at Week 8, 55.8% of subjects treated with VTAMA in ADORING 1 achieved the key secondary endpoint of the proportion of subjects with ≥75% improvement in EASI.
• 55.8% of subjects ≥12 years old, with a baseline PP-NRS score ≥4, achieved a ≥4-point reduction in the PP-NRS at Week 8.
• Importantly, VTAMA data indicated no new safety or tolerability signals in this population including children as young as 2 years old. Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events (1.9% VTAMA vs. 3.6% vehicle).
• Adverse events of special interest included contact dermatitis (1.5% VTAMA vs. 2.2% vehicle) and follicular event (10.0% VTAMA vs. 0.7% vehicle).

“Atopic dermatitis affects a significant number of children, and its prevalence continues to grow. Given the increasing need for an effective and well-tolerated, non-steroidal topical treatment option for the pediatric population, the efficacy and safety data from ADORING 1 results are encouraging and, combined with the positive results from the maximal usage pharmacokinetics (MUPK) study, VTAMA appears to have the potential to bring relief to children suffering from this disease,” says Adelaide A. Hebert, MD, professor and chief of pediatric dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann. “The prevalence of itch as an associated symptom makes this condition extremely burdensome not only to the patients suffering from AD, but also their families. In this regard, the itch data from ADORING 1, much like that from ADORING 2, emphasizes VTAMA’s effectiveness when it comes to disease control and VTAMA’s potential to reduce one of atopic dermatitis’ most burdensome symptoms.”

“It is a really exciting time for patients suffering from atopic dermatitis and clinicians who treat them. The positive topline data from ADORING 1 taken together with the positive results previously shown in ADORING 2 indicate that VTAMA has potential as a new non-steroidal topical medication option in atopic dermatitis, that can be used anywhere on the body surface, including sensitive areas, for both adults and children as young as two years old,” adds Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences in Washington, DC., and the Director of Clinical Research and Contact Dermatitis.

Dermavant recently released highly favorable results from a pediatric maximal usage pharmacokinetics (MUPK) study of VTAMA in AD. The study demonstrated minimal-to-no systemic exposure despite maximal use in subjects with extensive AD. Subjects were as young as 2 years old with up to 90% body surface area (BSA) affected with a mean BSA of 43%.