Medical dermatology company LEO Pharma said that Enstilar (LEO 90100) has achieved both primary and secondary endpoints in a Phase 3 trial in Chinese adult patients with stable plaque psoriasis.
Enstilar is an aerosol spray foam, comprising 50mcg/g of calcipotriol monohydrate and 0.5mg/g of betamethasone dipropionate.
It is said to be an improved formulation of Daivobet ointment, an existing standard treatment option in China.
The European Union has approved the spray foam to treat psoriasis vulgaris in adults for up to four weeks.
In the late-stage, randomised, investigator-blind, active controlled, parallel-group, multicentre Chinese trial assessed the efficacy and safety of once-daily use of Enstilar against Daivobet for four weeks.
The Denmark-based LEO Pharma enrolled 604 patients across 39 sites in China.
The primary endpoint of the Phase 3 study was to assess the efficacy of Enstilar in comparison to Daivobet ointment over the severity and extent of stable plaque psoriasis.
The secondary endpoints were to examine the safety of the treatments. Additionally, exploratory objectives involved assessing the impact on health-related quality of life.
According to the initial findings, Enstilar showed superiority over Daivobet ointment in the main objective. The former demonstrated efficacy in lowering the severity and extent of stable plaque psoriasis.
Daivobet ointment and Enstilar, both products of LEO Pharma, were well tolerated. Their safety profiles were found consistent with findings from previous trials, with no new safety concerns identified.
LEO Pharma global product strategy and international operations executive vice president Becki Morison said: “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.”
Based on the Phase 3 results, LEO Pharma is planning to initiate the necessary steps to submit Enstilar for approval to the Chinese authorities.
