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

• 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.

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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

1. 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)
2. 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
3. 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)
4. Enstilar^® EU Summary of Product Characteristics July 2022.
5. 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.
6. 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.
7. 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.
8. 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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