Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

LEO Pharma declares positive data from Phase III plaque psoriasis trial

Leo Pharma has released promising findings from a Phase III clinical trial of Enstilar (LEO 90100) for Chinese adult patients with stable plaque psoriasis. Enstilar, an aerosol spray foam, combines 50mcg/g calcipotriol monohydrate and 0.5mg/g betamethasone dipropionate, representing an advancement over the existing treatment, Daivobet ointment. In this multicentre, randomised, investigator-blind, active-controlled trial, 604 patients from 39 sites in China participated. The trial aimed to evaluate Enstilar's efficacy and safety compared to Daivobet over four weeks. Enstilar surpassed the ointment in achieving the primary goal of reducing plaque psoriasis severity and extent. Additionally, Enstilar showed superiority in both primary and secondary endpoints, indicating enhanced efficacy. Both treatments were well tolerated, with safety profiles consistent with previous trials. With these results, LEO Pharma plans to seek approval from Chinese regulatory authorities for Enstilar.