Roivant Reports Positive Topline Results from ADORING 2 Atopic Dermatitis Phase 3 Trial of VTAMA® (tapinarof) Cream, 1% Once Daily in Adults and Children as Young as 2 Years Old
Dermavant Sciences, a Roivant Sciences company, announced positive results from the ADORING 2 Phase 3 trial evaluating VTAMA cream for atopic dermatitis. The study demonstrated that 46.4% of subjects using VTAMA achieved the primary endpoint of clear or almost clear skin, significantly outperforming the vehicle group (18.0%, P<0.0001). Key secondary endpoints were also met, including a 59.1% improvement in EASI scores. The trial showed a rollover rate of 92.4% into a long-term safety study, indicating strong patient retention. VTAMA is already approved for plaque psoriasis, providing a potential advantage in treatment regimens for both children and adults.
- 46.4% of subjects achieved primary endpoint in ADORING 2 trial (P<0.0001).
- 59.1% of subjects met key secondary endpoint (EASI75, P<0.0001).
- High patient rollover rate (92.4%) into long-term safety study.
- No significant safety or tolerability issues reported.
- VTAMA cream is already FDA approved for plaque psoriasis, offering treatment simplicity.
- None.
46.4% of subjects receiving VTAMA cream,1% achieved the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus18.0% on vehicle (P<0.0001)- All secondary endpoints were met with a high degree of statistical significance, including
59.1% of subjects treated with VTAMA cream who achieved the key secondary endpoint of EASI75 (P<0.0001) - Meaningful impact on the key secondary endpoint of pruritus (itch) was demonstrated with
52.8% of subjects ≥12 years old, with a baseline PP-NRS score ≥4, achieving a ≥4-point reduction in the PP-NRS at Week 8 (P=0.0015) - Rollover rate of
92.4% of Phase 3 subjects from this trial into the open-label, long-term safety study* - Conference call and webcast on March 15, 2023 at 8:00 a.m. ET
LONG BEACH, Calif. and BASEL, Switzerland, March 15, 2023 (GLOBE NEWSWIRE) -- Dermavant Sciences, a Roivant Sciences (Nasdaq: ROIV) company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today 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,
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 >
Table 1: ADORING 2 Phase 3 Trial – Primary and Key Secondary Endpoints
ADORING 2 Week 8 | |||
Endpoint | VTAMA | Vehicle QD | P value |
vIGA-AD success1 | <0.0001 | ||
EASI752 | <0.0001 | ||
≥4-point reduction in PP-NRS3 | 0.0015 |
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 >
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,
“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,
- 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
On May 24, 2022, Dermavant announced the FDA approved VTAMA (tapinarof) cream,
Conference Call
Roivant will host a conference call and a live webcast on March 15, 2023 at 8:00 am ET to discuss the positive ADORING 2 topline results.
To access the conference call by phone, please register online using this registration link. A webcast of the call will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.
About Roivant Sciences
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, please visit www.roivant.com.
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IMPORTANT SAFETY INFORMATION
Indication: VTAMA® (tapinarof) cream,
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
See full Prescribing Information and Patient Information.
About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis
ADORING is Dermavant’s pivotal Phase 3 atopic dermatitis (AD) clinical program for VTAMA (tapinarof) cream,
About Atopic Dermatitis
Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affecting over 26 million people in the U.S. alone and up to
About Dermavant
Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes commercialized, late-stage and earlier-development product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream,
For more information, please visit www.dermavant.com and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).
*Dermavant DOF March 2023.
**National Eczema Association. Atopic Dermatitis. https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/
iIQVIA National Prescription Audit (NPA) for the 3-month period ending 2/24/2023, reflecting estimates of real-world activity. All rights reserved.
†NPA for the period 5/20/22 to 3/3/2023, reflecting estimates of real-world activity. All rights reserved.
© 2023 Dermavant Sciences, Inc. All Rights Reserved. VTAMA® is the registered trademark of Dermavant Sciences, GmbH. vIGA-AD(TM) is the trademark of Eli Lilly and Co.
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