Leo Pharma has revealed encouraging findings from a Phase III clinical trial evaluating Enstilar (LEO 90100) in Chinese adults with stable plaque psoriasis.
Enstilar, an aerosol spray foam, contains 50mcg/g calcipotriol monohydrate and 0.5mg/g betamethasone dipropionate, representing an advanced formulation derived from the existing treatment, Daivobet ointment.
The multicenter, randomized, investigator-blind, active-controlled, parallel-group trial examined the safety and efficacy of once-daily application of Enstilar compared to Daivobet ointment over four weeks, involving 604 patients across 39 sites in China.
The primary objective of the trial was to evaluate Enstilar’s efficacy versus Daivobet in managing stable plaque psoriasis severity and extent. Secondary objectives included assessing treatment safety and exploring impacts on health-related quality of life.
Recruitment for the trial concluded four months ahead of schedule, with topline results demonstrating Enstilar’s superior performance in achieving primary objectives. Enstilar also exhibited superiority across both primary and secondary endpoints, demonstrating enhanced efficacy in reducing the severity and extent of stable plaque psoriasis.
Both Daivobet ointment and Enstilar were well tolerated, with safety profiles consistent with previous trials and no new safety concerns identified.
Based on these promising outcomes, LEO Pharma is preparing to seek approval from Chinese authorities for Enstilar.
Becki Morison, Executive Vice President of Global Product Strategy and International Operations at LEO Pharma, commented, “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 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.”
Previously, in October, LEO Pharma reported positive data from the Phase III DELTA 3 trial of delgocitinib cream for the treatment of moderate to severe chronic hand eczema.
