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Dermavant
Announces Publication of ADORING 1 & ADORING 2 Pivotal Phase 3 Trials of
VTAMA
® (
tapinarof
) cream, 1% for Adults and Children 2 Years of Age and Older with
Atopic Dermatitis
in JAAD
2024-05-21
·
BioSpace
临床3期
临床结果
上市批准
免疫疗法
— ADORING 1 and ADORING 2 met their primary efficacy endpoints and all secondary endpoints — — ADORING 1 and ADORING 2 data were included in the sNDA filing for VTAMA cream, 1% in
atopic dermatitis
, submitted in February 2024 — LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--
Dermavant Sciences Inc.
, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that the data from ADORING 1 and ADORING 2, two identical, double-blind, randomized, vehicle-controlled pivotal Phase 3 trials of VTAMA® (
tapinarof
) cream, 1% for adults and children 2 years of age and older with atopic dermatitis (AD) has been published in the Journal of the American Academy of Dermatology.
VTAMA cream
is a novel,
aryl hydrocarbon receptor agonist
aryl hydrocarbon receptor
agonist in development as a once-daily, cosmetically elegant, and
steroid
-free, topical cream for both acute treatment and long-term management of AD.
VTAMA cream
, 1% is currently approved for the topical treatment of
plaque psoriasis
in adults in the U.S. and is the same strength and formulation studied in the ADORING Phase 3 development program and the subject of the sNDA submission for AD. “We are delighted to announce the publication of the pivotal Phase 3 ADORING trial results in the Journal of the American Academy of Dermatology, which further highlight the positive data of
VTAMA cream
and its potential as a safe and effective non-steroidal topical medication option for both adults and children with
atopic dermatitis
,” said Philip M. Brown, MD, JD, Chief Medical Officer of
Dermavant
. “As we have previously announced, we submitted our sNDA application for
VTAMA cream
for the treatment of
atopic dermatitis
earlier this year, and subject to
FDA
approval, we eagerly anticipate bringing
VTAMA cream
to patients, their caregivers, and the physicians who treat them.” Table 1: ADORING 1 and ADORING 2 Phase 3 Trials – Primary and Secondary Endpoints ADORING 1 Week 8 ADORING 2 Week 8 Endpoint VTAMA cream 1% QD (n=270) Vehicle QD (n=137) P Value
VTAMA cream
1% QD (n=271) Vehicle QD (n=135) P Value
vIGA-AD
success¹ 45.4% 13.9% <0.0001 46.4% 18.0% <0.0001 EASI75² 55.8% 22.9% <0.0001 59.1% 21.2% <0.0001 ≥4-point reduction in PP-NRS³ 55.8% (n=103) 34.2% (n=54) 0.0366 52.8% (n=126) 24.1% (n=64) 0.0015 1. Primary Endpoint: Proportion of patients who achieved a Validated Investigator Global Assessment for
Atopic Dermatitis
(vIGA-ADTM) score of clear (0) or almost clear (1) and ≥2-grade improvement from baseline at Week 8. 2. Secondary Endpoint: Proportion of patients with ≥75% improvement in
Eczema
Area and Severity Index (EASI) from baseline at Week 8. 3. Secondary Endpoint: Proportion of patients ≥12 years old with a baseline Peak
Pruritus
Numeric Rating Scale (PP-NRS) score ≥4 who achieved ≥4-point reduction in the PP-NRS from baseline at Week 8. ADORING 1 (N=407) and ADORING 2 (N=406), two pivotal Phase 3 studies that evaluated the efficacy and safety of
VTAMA cream
in adults and pediatric patients as young as 2 years old who had a Validated Investigator Global Assessment for
Atopic Dermatitis
(vIGA-AD) score of 3 (moderate) or 4 (severe) at baseline. In the pivotal trials,
VTAMA cream
demonstrated highly statistically significant improvement compared to vehicle (both P<0.0001) in achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 8, the primary endpoint.
VTAMA cream
also demonstrated highly statistically significant improvement in the proportion of patients who achieved ≥75% improvement in the EASI75 from baseline at Week 8 compared to patients on vehicle (both P<0.0001), a key secondary endpoint in the pivotal trials. Patients 12 years of age and older, the population for whom the PP-NRS has been validated, who received
VTAMA cream
also experienced a statistically significant improvement in
itch
as assessed by a ≥4-point improvement in the patient reported PP-NRS score compared to patients on vehicle (P=0.0366 for ADORING 1 and P=0.0015 for ADORING 2), another secondary endpoint.
VTAMA cream
data indicated no new safety or tolerability signals of concern in this population including children 2 years of age and older. Adverse events of special interest included
contact dermatitis
, follicular events, and
headache
. Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events. “The positive data from ADORING 1 and ADORING 2 indicate that
VTAMA cream
has potential as a new non-steroidal topical treatment for
atopic dermatitis
, that could be used on any affected area, for both adults and children as young as two years old,” said 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
. “In addition, the
itch
data from ADORING 1 and 2 speaks to
VTAMA cream
’s potential to reduce one of the disease’s most burdensome symptoms.” On May 24, 2022,
Dermavant
announced the
FDA
approved
VTAMA
® (
tapinarof
) cream, 1% for the treatment of
plaque psoriasis
in adults. The approval made
VTAMA cream
the first non-steroidal topical novel chemical entity launched for
plaque psoriasis
in the U.S. in more than 25 years.
VTAMA cream
is approved for mild, moderate, and severe
plaque psoriasis
in adults – with no label safety warnings or precautions, or restrictions on duration of use or body surface area. On February 12, 2024,
Dermavant
submitted a Supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA)
for
VTAMA
® (
tapinarof
) cream, 1% for the topical treatment of
atopic dermatitis (AD)
in adults and children 2 years of age and older. IMPORTANT SAFETY INFORMATION Indication:
VTAMA
® (
tapinarof
) cream, 1% is an
aryl hydrocarbon receptor agonist
aryl hydrocarbon receptor
agonist indicated for the topical treatment of
plaque psoriasis
in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with
VTAMA cream
were
folliculitis
(red raised bumps around the hair pores),
nasopharyngitis
(
pain
or
swelling
in the nose and throat),
contact dermatitis
(
skin rash
or irritation, including
itching
and redness, peeling, burning, or stinging),
headache
,
pruritus
(itching)
, and
influenza
(flu)
. You are encouraged to report negative side effects of prescription drugs to the
FDA
. Visit 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 Phase 3
atopic dermatitis (AD)
clinical development program for
VTAMA
® (
tapinarof
) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, extension trial. About
Atopic Dermatitis
Atopic dermatitis (AD)
, commonly referred to as
eczema
, is one of the most common
inflammatory skin diseases
, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck.
Itching
is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing
fatigue
, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease. 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 earlier-development, late-stage and commercialized 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, 1%, for the topical treatment of
plaque psoriasis
in adults. The
FDA
approved
VTAMA cream
for the topical treatment of mild, moderate, and severe
plaque psoriasis
in May 2022.
Dermavant
has been developing
VTAMA cream
for the treatment of
atopic dermatitis
in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023.
Dermavant
’s pipeline includes
DMVT-506
, a next generation
aryl hydrocarbon receptor (AhR)
agonist under development as a potential treatment option for
immunological and inflammatory diseases
with multiple potential routes of administration. For more information, please visit and follow us on Twitter (@dermavant) and LinkedIn (
Dermavant Sciences
). ©2024
Dermavant Sciences, Inc.
All Rights Reserved.
Dermavant
and VTAMA are the registered trademarks of
Dermavant Sciences
, GmbH. vIGA-AD is the trademark of
Eli
Lilly and Co.
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机构
Dermavant Sciences GmbH
US Food & Drug Administration
George Washington University Law School
[+3]
适应症
特应性皮炎
斑块状银屑病
阿尔茨海默症
[+13]
靶点
AHR
药物
本维莫德
SM-350300
ORIL-003
[+1]
标准版
¥
16800
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