LEO Pharma Announces Topline Results of Phase 3 Trial in China for Enstilar® (LEO 90100) Demonstrating Superiority in Adult Chinese Subjects With Stable Plaque Psoriasis
2024年5月8日 - 3:00AM
ビジネスワイヤ(英語)
- Enstilar® (LEO 90100) showed superiority over Daivobet®
ointment in primary and both secondary endpoints in the testing
hierarchy showing improved efficacy in reducing the severity and
extent of stable plaque psoriasis.
- Overall, both Daivobet ointment and Enstilar – each of them LEO
Pharma products – were well tolerated. Safety profiles were
consistent with previous trial findings and as expected with no new
safety concerns identified.
- The trial is a commitment of LEO Pharma’s expanding presence in
China, making a fundamental difference for Chinese patients living
with psoriasis through additional treatment options.
- Enstilar – a unique cutaneous foam formulation built on the
active ingredients of Daivobet – is a global market leader in
topical psoriasis.
GLOBAL RELEASE – NOT INTENDED FOR DISTRIBUTION IN THE
UK
LEO Pharma A/S, a global leader in medical dermatology, today
announces positive results from the Enstilar® phase 3 trial in
China in adult patients living with stable plaque psoriasis.
The trial is a phase 3, randomised, investigator-blind, active
controlled, parallel group, multicentre trial comparing the
efficacy and safety of once daily application with Enstilar (LEO
90100) and Daivobet® ointment for 4 weeks of treatment in adult
Chinese subjects with stable plaque psoriasis. A total of 604
patients were recruited across 39 sites in China.1
The primary objective of the study was to evaluate the efficacy
of Enstilar (LEO 90100) compared with Daivobet® ointment on
severity and extent of stable plaque psoriasis. The secondary
objective evaluated treatment safety. Exploratory objectives
included evaluating health-related quality of life.1
The topline results show that Enstilar demonstrated superiority
to Daivobet ointment in the primary objective.
“With these inspiring clinical results, we are very happy to be
able to proceed towards submission of Enstilar to the Chinese
authorities, but I am equally pleased that we will now proceed
towards hopefully providing Chinese patients with a new treatment
option for their psoriasis in addition to the existing portfolio
offering from LEO Pharma China,” says Byron Yin, General Manager
for LEO Pharma in China.
Professor Zhang Jianzhong from Peking University People's
Hospital, the leading principal investigator of this study,
states:
“In China, approximately 7 million patients are affected by this
condition2. Topical medications are the basic treatment for
psoriasis and are suitable for most patients. As a principal
investigator in this study, I am delighted to see that Enstilar has
achieved its primary and secondary endpoints in the Phase III
clinical trial in Chinese patients, demonstrating superior efficacy
to Daivobet with a good safety profile. I look forward to sharing
detailed data from this high-quality study in the near future. I
look forward to sharing detailed data from the study soon and hope
it will help us provide another treatment option to psoriasis
patients in China.”
Dual brand trial shows LEO Pharma’s strength in China
Enstilar – a calcipotriol/betamethasone cutaneous foam – is an
improved formulation of Daivobet ointment, which is one of the
current standard treatment options in China for adults living with
stable plaque psoriasis.3
The trial completed recruitment four months ahead of schedule
and is a commitment to LEO Pharma’s increasing presence and
activities in China.
“The results of this trial are very encouraging for LEO Pharma’s
presence in China. Not only do we see superiority in the results,
but we also see that both portfolio products were efficacious and
well tolerated. This is a key market for LEO Pharma – with
dermatology growing rapidly in the country and our revenue steadily
increasing through a strong performance from our team in China.
This trial is a good example of how LEO Pharma is leveraging our
deep dermatology knowledge to expand both our innovative and core
portfolios in China,” says Becki Morison, Executive Vice President,
Global Product Strategy & International Operations for LEO
Pharma.
Following the results, LEO Pharma will proceed with preparations
to submit Enstilar for approval with the Chinese authorities.
Detailed results from the Enstilar China trial will be submitted
for scientific presentation and publication at a later date. For
more information on the Enstilar trial (NCT05919082) go to
clinicaltrials.gov.
About Enstilar®
Enstilar® is an aerosol spray foam containing calcipotriol
monohydrate 50 mcg/g and betamethasone dipropionate 0.5 mg/g. In
the EU, it is indicated for the treatment of psoriasis vulgaris in
adults for up to 4 weeks. Patients who have responded at 4 weeks’
treatment using Enstilar once daily are suitable for long-term
maintenance treatment. 3-6
About Psoriasis
Psoriasis is a chronic, inflammatory skin disease, which is
frequently accompanied by multiple physical and/or psychological
comorbidities (the presence of one or more additional diseases),
such as psoriatic arthritis, diabetes, cardiovascular disease and
depression.7 8
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the
standard of care for the benefit of people with skin conditions,
their families and society. Founded in 1908 and majority owned by
the LEO Foundation, LEO Pharma has devoted decades of research and
development to advance the science of dermatology, and today, the
company offers a wide range of therapies for all disease
severities. LEO Pharma is headquartered in Denmark with a global
team of 4,200 people, serving millions of patients across the
world. In 2023, the company generated net sales of DKK 11.4
billion.
References
- ClinicalTrials.gov: A Study to Investigate Efficacy and Safety
With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese
Subjects With Stable Plaque Psoriasis | ClinicalTrials.gov
(Accessed May 2024)
- Ding, XL et al. Prevalence of psoriasis in China: A
population-based study in six cities. European Journal of
dermatology: EJD 22(5):663-7
- Zhang, XJ et al., Chin J Dermatol, July 2023, Vol. 56, No. 7,
Guideline for the diagnosis and treatment of psoriasis in China
(2023 edition)
- Enstilar® EU Summary of Product Characteristics July 2022.
- Koo J, et al. Superior efficacy of calcipotriene and
betamethasone dipropionate aerosol foam versus ointment in patients
with psoriasis vulgaris—A randomized phase II study. Journal of
Dermatological Treatment. 2016;27(2):120-127.
- Leonardi C, et al. Efficacy and Safety of Calcipotriene Plus
Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis
Vulgaris—a Randomized Phase III Study (PSO-FAST). J Drugs Dermatol.
2015;14(12):1468-1477.
- Lebwohl M, et al. Fixed Combination Aerosol Foam Calcipotriene
0.005% (Cal) Plus Betamethasone Dipropionate 0.064% (BD) is More
Efficacious than Cal or BD Aerosol Foam Alone for Psoriasis
Vulgaris: A Randomized, Double-blind, Multicenter, Three-arm, Phase
2 Study. J Clin Aesthet Dermatol. 2016;9(2):34-41.
- National Psoriasis Foundation. Comorbidities associated with
psoriatic disease. Available
www.psoriasis.org/about-psoriasis/related-conditions. Last accessed
May 2024
MAT-73304 May 2024
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version on businesswire.com: https://www.businesswire.com/news/home/20240507292614/en/
Jes Frederiksen Senior Manager, LEO Pharma Global Product &
Data Communications +45 53 60 59 48 jebfe@leo-pharma.com Judy Jiang
PR & Communication Manager, LEO Pharma China +86 188 1805 0413
XUJIA@leo-pharma.com