Roivant Reports Positive Topline Results From Phase 3 Trial of VTAMA (tapinarof) Cream, 1% Once Daily in Adults & Children as Young as 2

Dermavant Sciences, a Roivant Sciences (Nasdaq: ROIV) company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, recently announced positive results from ADORING 2, one of two double-blind, randomized, vehicle-controlled Phase 3 studies to evaluate the efficacy and safety of topical VTAMA (tapinarof) cream, 1% in pediatric subjects down to 2 years old and adult subjects with atopic dermatitis (AD).

In ADORING 2 (N=406), VTAMA cream met the primary endpoint of the trial and demonstrated highly statistically significant improvement in the vIGA-AD score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8 (P<0.0001).

Additionally, VTAMA cream demonstrated highly statistically significant improvement in the proportion of subjects with >75% improvement in EASI75 from baseline at week 8 (P<0.0001), a key secondary endpoint. Subjects 12 years and older receiving VTAMA cream also experienced a highly statistically significant improvement >4-point reduction in Peak Pruritis Numeric Rating Scale (PP-NRS) in itch (P=0.0015), another key secondary endpoint in the study due to its prevalence among AD sufferers.

Table 1. ADORING 2 Phase 3 Trial – Primary and Key Secondary Endpoints

¹Primary Endpoint: Proportion of subjects who achieved a vIGA-AD score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8.
²Secondary Endpoint: Proportion of subjects with >75% improvement in EASI from baseline at Week 8.
³Secondary Endpoint: Proportion of subjects ≥12 years old with a baseline PP-NRS score ≥4 who achieve ≥ 4-point reduction in the PP-NRS from baseline at Week 8.

Both adult and pediatric AD subjects receiving VTAMA cream, 1% did so at the same dose and dose regimen as already 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 both physicians, pharmacists, and patients, regardless of diagnosis.

“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, MD, JD, Chief Medical Officer at Dermavant. “Atopic dermatitis, the most common type of eczema, affects more than 9.6 million children and 16.5 million adults in the United States. The majority of patients diagnosed with atopic dermatitis 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.^** We now keenly anticipate topline data from our identically designed ADORING 1 trial in May 2023.”

VTAMA cream 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 cream is already approved for the topical treatment of plaque psoriasis in adults.

Topline Results
In ADORING 2, pediatric and adult subjects with atopic dermatitis were randomized at a 2:1 ratio to receive once daily (QD) treatment with VTAMA cream, 1% or vehicle cream.

• At week 8, 46.4% of subjects treated with VTAMA cream in ADORING 2 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 (P<0.0001).
• Also at week 8, 59.1% of subjects treated with VTAMA cream in ADORING 2 achieved the key secondary endpoint of the proportion of subjects with >75% improvement in EASI (P<0.0001).
• 52.8% of subjects ≥12 years old, with a baseline PP-NRS score ≥4, achieved a ≥4-point reduction in the PP-NRS at Week 8 (P=0.0015).
• Importantly, VTAMA cream data indicated no safety or tolerability signals in this population including children as young as 2 years old. Adverse events were mild to moderate with a low study discontinuation rate due to adverse events (1.5% VTAMA vs. 3.0% vehicle).
• Adverse events of special interest included contact dermatitis (1.1% VTAMA vs. 1.5% vehicle) and follicular event (8.9% VTAMA vs. 1.5% vehicle).

“Atopic dermatitis can have a negative impact on the quality of life of diagnosed children as well as their families. Both the efficacy and itch data from the ADORING 2 trial are highly encouraging in this regard, pointing to VTAMA cream as a potential non-steroidal topical treatment option for AD that is safe and well tolerated in children,” said Lawrence Eichenfield, M.D. Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego. “Importantly, the potential to use the same dose regimen with VTAMA cream for children and adults with AD offers treatment simplicity for prescribers, helped even more by the fact that it is the same regimen already being used for plaque psoriasis.”

“The topline results from ADORING 2 underscore VTAMA cream as a potential well-tolerated therapeutic with a favorable safety profile,” said Linda Stein Gold, M.D., Director of Clinical Research and the Division Head of Dermatology at the Henry Ford Health System. “When one considers this Phase 3 data alongside the recently reported pediatric maximal usage pharmacokinetic (MUPK) AD study, which in treated patients demonstrated minimal-to-no-systemic exposure despite heavy disease burden, VTAMA cream is positioning itself to be a potential two-in-one first-line topical treatment for both atopic dermatitis and plaque psoriasis.”

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

On May 24, 2022, Dermavant announced the FDA approved VTAMA (tapinarof) cream, 1% for the treatment of adult plaque psoriasis. The approval made VTAMA cream the first non-steroidal topical novel chemical entity launched for psoriasis in the U.S. in more than 25 years. VTAMA cream is approved for mild, moderate, and severe plaque psoriasis – with no label safety warnings or precautions, restrictions on duration of use or body surface area. On July 15, 2022, VTAMA cream became the #1 prescribed branded topical treatment for plaque psoriasisⁱ and to date has over 110,000 prescriptions written with over 9,300 unique prescribers^†.

Roivant’s mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants – nimble and focused biopharmaceutical and health technology companies. For more information, visit www.roivant.com.