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Dermavant
Announces Positive Results from Phase 4 Open-Label Trial of
VTAMA
® (
tapinarof
) Cream, 1% for the Treatment of
Plaque Psoriasis
in the Head and Neck Region in Adults
2023-12-06
·
BioSpace
临床结果
临床3期
上市批准
- 88.5% of adult patients achieved a target lesion Physician Global Assessment (tPGA) score of 0 (clear) or 1 (almost clear) and ≥ 2-grade improvement from baseline at Week 12 (tPGA Success), reinforcing strong efficacy in these areas - - 80.8% of adult patients achieved tPGA score of 0 (clear) at Week 12, indicating complete clearance of the target
plaque psoriasis
lesion in the head and neck region – - 96.2% of patients achieved ≥75% improvement in
Psoriasis
Area and Severity Index (PASI75) of the head and neck region at Week 12 - - 70% of the adult patients achieved the widely followed standard of improvement in itch as measured by the Peak Pruritis-Numeric Rating Scale (PP-NRS) (head and neck region) of ≥ 4 points at Week 12, with some patients achieving this meaningful reduction in
itch
as early as Week 1 - - 96.7% of patients strongly agreed or agreed that
VTAMA cream
quickly absorbs and 93.3% of subjects strongly agreed or agreed that
VTAMA cream
was not greasy, including hair-bearing areas such as the scalp - - No new safety signals were observed over 12 weeks - 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 positive results from its Phase 4, open-label clinical trial of
VTAMA
® (
tapinarof
) cream, 1% for the treatment of
plaque psoriasis
in the head and neck region in adults (N=31). “Up to 80% of patients with
plaque psoriasis
experience
scalp psoriasis
, making it one of the most affected areas of the body. In this Phase 4 trial, a majority of the adult patients suffered from
scalp psoriasis
, making the outcomes from this trial significant, as they further reinforce the efficacy, safety, tolerability, and cosmetic elegance of
VTAMA cream
even when used in hair bearing areas such as the head and neck region,” said Philip M. Brown, MD, JD, Chief Medical Officer at
Dermavant
. “The Phase 3 PSOARING studies and the Phase 4, open-label, intertriginous
plaque psoriasis
study combined with the Phase 4, open-label, head and neck data announced today, highlight the versatility of
VTAMA cream
, an efficacious, safe and well tolerated, non-steroidal treatment option for
plaque psoriasis
in all affected areas of the body.” This Phase 4, open-label study expands the body of data for
VTAMA cream
in adult
plaque psoriasis
. In the two 12-week Phase 3 pivotal studies (PSOARING 1 and 2; N=1025),
VTAMA cream
demonstrated a Physician Global Assessment (PGA) success rate* of 36% and 40% for adult patients with
plaque psoriasis
versus 6% for patients on vehicle at Week 12, respectively. DMVT-505-4002 (NCT05789576) was a Phase 4, open-label multi-center study to investigate the efficacy and safety of
VTAMA
(
tapinarof
) cream, 1% for the treatment of adults with
plaque psoriasis
specifically in the head and neck region. The efficacy of
VTAMA cream
was assessed using a PGA evaluation of a target
plaque psoriasis
lesion in the head and neck region, Scalp n=18 (58.1%), Face n=11 (35.5%) and Neck n=2 (6.5%) identified at baseline. The trial enrolled 31 participants with mild, moderate, and severe
head and neck plaque psoriasis
(tPGA score ≥2) aged 18 years or older at 8 sites across the U.S. Patients received
VTAMA cream
once daily for 12 weeks with a follow up one week after study completion. Safety and tolerability were assessed by visit based on adverse events and local tolerability scores using the investigator-assessed Local Tolerability Scale (LTS) of the head and neck region and a Patient Satisfaction Questionnaire (PSQ) that was designed to assess patients’ satisfaction with
VTAMA cream
’s efficacy, formulation elegance, application ease, impact on daily life, and preference versus prior therapies. The primary endpoint of the study was the proportion of adult patients who achieved a tPGA score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12 (tPGA Success). The secondary endpoint of the study was the time to achieve tPGA Success. Additional exploratory endpoints of the study included ≥75% improvement in PASI, change from baseline in Peak
Pruritus
-Numeric Rating Scale (PP-NRS), ≥4point reduction in PP-NRS, and improvement in DLQI. Efficacy and PP-NRS assessments were specific to the head and neck region. Phase 4 Results Primary and Secondary Endpoints
VTAMA cream
reinforced strong efficacy for the treatment of
head and neck plaque psoriasis (PsO)
, with 88.5% of adult patients (n=23/26) achieving a tPGA Success score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12, the primary endpoint of the study.
VTAMA cream
showed a rapid onset of efficacy with tPGA Success achieved as early as Week 1 in some patients, with a median time of approximately 4 weeks, the secondary endpoint of the study. Additional Endpoints At Week 12, 80.8% (n=21/26) of adult patients achieved complete clearance of the target lesion (tPGA=0) which was observed as early as Week 1 and with a median time of 8 weeks. At Week 12, 96.2% (n=25/26) of patients achieved PASI75 (≥75% reduction in PASI of the head and neck region), with achievement observed as early as Week 1. Onset of
itch
relief was apparent as early as Week 1 and increased over time with 70% (n=14/20) of patients achieving a clinically meaningful ≥4-point improvement in PP-NRS at Week 12. Substantial and clinically meaningful improvement in quality of life, as indicated by a 4-point improvement in DLQI, was achieved as early as Week 1 with further improvement out to Week 12. As indicated on the Patient Satisfaction Questionnaire, 93.3% (n=28/30) of subjects strongly agreed or agreed that
VTAMA cream
was not greasy, 86.7% (n=26/30) of subjects strongly agreed or agreed that
VTAMA cream
was easy to apply, and 96.7% (n=29/30) of subjects strongly agreed or agreed that
VTAMA cream
absorbs quickly. Safety and Tolerability
VTAMA cream
was well tolerated with no new safety signals. The most common adverse reactions (incidence ≥ 5%) in subjects treated with
VTAMA cream
were
folliculitis
,
contact dermatitis
,
headache
,
sinusitis
, and
seborrheic keratosis
. “
Plaque psoriasis
is a chronic condition with a significant negative impact on patients’ quality of life. The scalp region, in particular, is one of the most difficult areas to treat. Many currently available treatment options fail to offer sustained long-term relief due to lack of practical applicability to certain body areas and limitations on the duration of use,” said G. Michael Lewitt, MD, FAAD, Board-Certified Dermatologist,
Illinois Dermatology Institute
. “The impressive levels of efficacy achieved by
VTAMA cream
in the open-label trial, where 80% of adult patients achieved complete clearance of the target lesion, is highly encouraging for both patients with
plaque psoriasis
and their healthcare providers. Importantly, 58% of patients enrolled in the trial had a target
plaque psoriasis
lesion in the scalp region, and as assessed by both the investigators and the patients in the trial,
VTAMA cream
demonstrated favorable tolerability even when applied in hair bearing affected areas; making it a versatile and cosmetically elegant treatment option for
plaque psoriasis
that can be used anywhere on the affected body areas, including the most sensitive areas as well the scalp, head, and neck areas.” On May 24, 2022,
Dermavant
announced that 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
- 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 psoriasis
in adultsi and to date has over 250,000 prescriptions written by over 12,000 unique prescribers†. 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
Psoriasis
Impacting approximately 8 million Americans and 125 million people worldwide,
psoriasis
is a complex
autoimmune disease
— meaning that the body’s immune system targets and attacks its own cells.
Plaque psoriasis
, also called
psoriasis vulgaris
, is the most common form and affects about 80% to 90% of people with
psoriasis
. In people with light skin,
plaque psoriasis
is characterized by raised, red or pink patches of skin with silvery-white scales. People with black or brown skin are more likely to have brown or violet-colored patches with silvery-white or gray scales. The scales can be itchy, painful, and disfiguring.
Psoriasis
can begin at any age, but typically appears around 15 to 25 years of age and 50 to 60 years of age. The exact cause of
psoriasis
is not known, but risk factors and triggers may include genetics or a family history of
psoriasis
, as well as stress, smoking, heavy alcohol consumption and cold or dry weather conditions. People with
psoriasis
are at an increased risk of developing other health conditions, including
psoriatic arthritis
,
inflammatory bowel disease
,
hypertension
,
diabetes
,
obesity
, and
depression
. In addition to physical symptoms,
psoriasis
can have a significant impact on a person’s quality of life and psychological health. 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
is also developing
VTAMA cream
for the treatment of
atopic dermatitis
in adults and children as young as 2 years old 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 X (@dermavant) and LinkedIn (
Dermavant Sciences
). *PGA success: PGA score of 0 or 1 and ≥2-grade improvement from baseline at Week 12. iIQVIA National Prescription Audit (NPA) for the 3-month period ending 11/24/2023, reflecting estimates of real-world activity. All rights reserved. †IQVIA NPA for the period 5/20/22 to 11/24/2023, reflecting estimates of real-world activity. All rights reserved. ©2023
Dermavant Sciences, Inc.
All Rights Reserved. All trademarks are the property of
Dermavant Sciences, GmbH
.
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机构
Dermavant Sciences GmbH
Dermavant Sciences, Inc.
Illinois Dermatology Institute LLC
[+1]
适应症
斑块状银屑病
银屑病
瘙痒
[+21]
靶点
AHR
药物
本维莫德
SM-350300
DMVT-506
标准版
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16800
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