- Ruxolitinib cream resulted in a rapid and
robust clinical response, with significantly more patients
achieving Investigator’s Global Assessment (IGA) Treatment Success
(IGA-TS; primary endpoint), defined as an IGA score of 0 (clear) or
1 (almost clear), and EASI75 (key secondary endpoint), defined as
the proportion of patients who achieved a ≥ 75% improvement in the
Eczema Area and Severity Index Score - Treatment with ruxolitinib
cream also resulted in a rapid, substantial and sustained reduction
in itch, a key quality of life measure for patients with atopic
dermatitis - Data support the planned submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration before
the end of 2020
Incyte (Nasdaq: INCY) today announced the first presentation of
Phase 3 data for ruxolitinib cream in atopic dermatitis at the
Revolutionizing Atopic Dermatitis Virtual Symposium. The Phase 3
TRuE-AD program, which includes the TRuE-AD1 and TRuE-AD2 studies,
is evaluating ruxolitinib cream 0.75% and 1.5% twice daily (BID)
for the treatment of patients with mild-to-moderate atopic
dermatitis.
“Data that will be presented today during the Revolutionizing
Atopic Dermatitis Virtual Symposium show that ruxolitinib cream
significantly reduced both the skin inflammation and itch
associated with atopic dermatitis. The reduction in itch can
potentially improve key disease-related and quality of life
outcomes for patients living with atopic dermatitis,” said Jim Lee,
M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity,
Incyte. “We are pleased to share these important data with the
dermatology community, as they support the potential of ruxolitinib
cream to become an important antipruritic and anti-inflammatory
treatment option for patients with atopic dermatitis, and we look
forward to submitting a New Drug Application (NDA) to the U.S. Food
and Drug Administration later this year.”
The primary endpoint for the TRuE-AD1 and TRuE-AD2 studies was
the proportion of patients achieving Investigator’s Global
Assessment (IGA) Treatment Success (IGA-TS), defined as an IGA
score of 0 (clear) or 1 (almost clear) with at least a two-point
improvement from baseline, at Week 8. Key secondary endpoints
included the proportion of patients who achieved a ≥ 75%
improvement in Eczema Area and Severity Index (EASI75) score at
Week 8 and the proportion of patients with a ≥ 4-point improvement
in Itch Numerical Rating Scale (NRS4) score at Week 8.
As previously reported, both Phase 3 studies met the primary
endpoint. Significantly more patients treated with ruxolitinib
cream 0.75% BID [TRuE-AD1: 50.0%; TRuE-AD2: 39.0%] and 1.5% BID
[TRuE-AD1: 53.8%; TRuE-AD2: 51.3%] achieved IGA-TS compared to
vehicle [non-medicated cream; TRuE-AD1: 15.1%; TRuE-AD2: 7.6%]; P
< 0.0001. Additionally, a significant proportion of patients
treated with ruxolitinib cream 0.75% BID [TRuE-AD1: 56.0%;
TRuE-AD2: 51.5%] and 1.5% BID [TRuE-AD1: 62.1% and TRuE-AD2: 61.8%]
achieved EASI75 at Week 8 compared to vehicle [TRuE-AD1: 24.6%;
TRuE-AD2: 14.4%]; P < 0.0001.
Data from both studies also demonstrate that treatment with
ruxolitinib cream has a rapid, substantial and sustained impact on
itch, a key quality of life measure for patients living with atopic
dermatitis:
- Significantly more patients treated with ruxolitinib cream
experienced a clinically meaningful reduction in itch (NRS4) than
patients given vehicle at Week 8.
- In TRuE-AD1, 40.4% of patients treated with ruxolitinib cream
0.75% BID and 52.2% of patients treated with ruxolitinib cream 1.5%
BID achieved NRS4, compared to 15.4% of patients given vehicle (P
< 0.001 and P < 0.0001, respectively).
- In TRuE-AD2, 42.7% of patients treated with ruxolitinib cream
0.75% BID and 50.7% of patients treated with ruxolitinib cream 1.5%
BID achieved NRS4, compared to 16.3% of patients given vehicle (P
< 0.0001).
- A rapid reduction in itch was observed with ruxolitinib cream
treatment. A significantly greater reduction in the itch Numerical
Rating Scale (NRS) was observed within 12 hours of treatment with
ruxolitinib cream 1.5% BID compared to vehicle (P < 0.05).
The overall safety profile of ruxolitinib cream in atopic
dermatitis was consistent with previous study data, with no new
safety signals observed. The long-term safety of ruxolitinib cream
is currently being evaluated in the 44-week extension period of
both studies.
“Atopic dermatitis can have a profound impact on patients and
their quality of life. I see a need for more treatment options that
can improve itch and other symptoms that can lead to disruption in
activities of daily living,” said Kim Papp, M.D., Ph.D., Founder
and President of Probity Medical Research and the Coordinating
Investigator for the TRuE-AD program. “I am encouraged by these
data. The potential of ruxolitinib cream to become an important
treatment option for patients living with atopic dermatitis is
exciting.”
These data will be presented as part of the Revolutionizing
Atopic Dermatitis Virtual Symposium during the Late Breaking
Abstracts session on Sunday, April 5, from 3:56-4:09 p.m. EDT.
About Atopic Dermatitis Atopic dermatitis (AD) is a
common chronic disease characterized by inflammation of the skin.
At least 11 million people in the United States have been diagnosed
with and are being treated for AD. The majority of these patients
have a mild or moderate form of the disease and approximately 80%
are adults or adolescents. Signs and symptoms of AD include
irritated and itchy skin that can cause red lesions that may ooze
and crust. Patients with AD are also more susceptible to bacterial,
viral and fungal infections.
About TRuE-AD The TRuE-AD clinical trial program consists
of two randomized, double-blind, dose-ranging, vehicle-controlled
Phase 3 studies, TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651),
evaluating the safety and efficacy of ruxolitinib cream compared to
vehicle (non-medicated cream) in patients with atopic dermatitis
(AD). Both studies enrolled more than 600 patients (age ≥ 12 years)
diagnosed with AD for at least two years and who were candidates
for topical therapy.
Patients with an Investigator’s Global Assessment (IGA) score of
2 to 3, and with AD on 3% to 20% of their Body Surface Area (BSA)
(excluding scalp) were randomized 2:2:1 into one of three treatment
arms for eight weeks, including: ruxolitinib cream 0.75%
administered twice daily (BID); ruxolitinib cream 1.5% BID; and
vehicle (non-medicated cream). Participants who successfully
completed an assessment at Week 8 were offered participation in the
44-week long-term safety treatment extension period with
ruxolitinib cream 0.75% or 1.5% BID.
The primary endpoint of the TRuE-AD studies was the proportion
of participants achieving an Investigator’s Global Assessment
Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or
1 (almost clear) with at least a 2-point improvement from baseline
at Week 8. Key secondary endpoints include: the proportion of
patients achieving at least a 75% improvement from baseline in the
Eczema Area and Severity Index (EASI75) score – another measurement
of the extent and severity of AD, and the proportion of
participants with at least a four-point improvement in the itch
numerical rating scale (NRS4). The studies have also been tracking
the frequency, duration and severity of adverse events associated
with the use of ruxolitinib cream.
For more information about the TRuE-AD studies, please visit
http://clinicaltrials.gov/ct2/show/NCT03745638 and
http://clinicaltrials.gov/ct2/show/NCT03745651.
About Ruxolitinib Cream Ruxolitinib cream is a
proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor
ruxolitinib that has been designed for topical application.
Ruxolitinib cream is currently in Phase 3 development for the
treatment of patients with mild-to-moderate atopic dermatitis
(TRuE-AD) and for the treatment of adolescents and adults with
vitiligo (TRuE-V). Incyte has worldwide rights for the development
and commercialization of ruxolitinib cream.
Conference Call Information Incyte will host an investor
conference call and webcast at 8:00 a.m. EDT on Monday, April 6,
2020. The webcast will be available via investor.incyte.com.
To access the conference call on Monday, April 6, 2020, please
dial 877-407-3042 for domestic callers or +1-201-389-0864 for
international callers. When prompted, provide the conference
identification number, 13700027.
If you are unable to participate, a replay of the conference
call will be available for 30 days. The replay dial-in number for
the United States is 877-660-6853 and the dial-in number for
international callers is +1-201-612-7415. To access the replay you
will need the conference identification number, 13700027.
About Incyte Incyte is a Wilmington, Delaware-based,
global biopharmaceutical company focused on finding solutions for
serious unmet medical needs through the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit Incyte.com and follow
@Incyte.
Forward-Looking Statements Except for the historical
information set forth herein, the matters set forth in this press
release, including statements regarding the presentation of data
from the Company’s ongoing clinical development program for
ruxolitinib cream, whether and when the Company will file an NDA
for ruxolitinib cream, and whether ruxolitinib cream will be
approved for use in the U.S. or elsewhere, contain predictions,
estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s
current expectations and subject to risks and uncertainties that
may cause actual results to differ materially, including
unanticipated developments in and risks related to: unanticipated
delays; further research and development and the results of
clinical trials possibly being unsuccessful or insufficient to meet
applicable regulatory standards or warrant continued development;
the ability to enroll sufficient numbers of subjects in clinical
trials; determinations made by the FDA; the Company’s dependence on
its relationships with its collaboration partners; the efficacy or
safety of the Company’s products and the products of the Company’s
collaboration partners; the acceptance of the Company’s products
and the products of the Company’s collaboration partners in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; greater than expected expenses;
expenses relating to litigation or strategic activities; and other
risks detailed from time to time in the Company’s reports filed
with the Securities and Exchange Commission, including its Form
10-K for the year ended December 31, 2019. The Company disclaims
any intent or obligation to update these forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20200405005012/en/
Incyte Contacts Media
Catalina Loveman +1 302 498 6171 cloveman@incyte.com
Investors Michael Booth, DPhil +1 302 498 5914
mbooth@incyte.com
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