LEO Pharma has shared positive results from a late-stage trial of Enstilar (LEO 90100) in adults with stable plaque psoriasis.
Between 2% and 3% of the global population has some form of psoriasis, a chronic inflammatory condition that typically affects the skin, nails and joints.
Up to 90% of patients have plaque psoriasis, characterised by distinct round or oval plaques typically covered by silvery-white scales.
LEO outlined that Enstilar, an aerosol spray foam containing calcipotriol monohydrate and betamethasone dipropionate, is an “improved formulation” of its Daivobet ointment, a current standard treatment option for plaque psoriasis.
Enstilar is already authorised in the EU to treat psoriasis vulgaris in adults for up to four weeks and as a long-term maintenance treatment for those who have responded to the initial treatment. The therapy also holds approvals in other markets worldwide.
The phase 3 trial has been comparing the efficacy and safety of a once-daily application of Enstilar against Daivobet ointment for four weeks in more than 600 stable plaque psoriasis patients across China.
Enstilar was superior to Daivobet in the primary endpoint, demonstrating improved efficacy in reducing the severity and extent of stable plaque psoriasis.
Both treatments were well tolerated and their safety profiles were consistent with previous trial findings.
Leading principal investigator, professor Zhang Jianzhong, Peking University People’s Hospital, said: “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 3 clinical trial in Chinese patients, demonstrating superior efficacy to Daivobet with a good safety profile.”
The readout comes just a few months after LEO announced positive results from a head-to-head study of its investigational JAK-inhibitor cream, delgocitinib, in adults with severe chronic hand eczema.
According to the results shared at the end of January, the primary endpoint of the trial was met after delgocitinib cream demonstrated a superior reduction in Hand Eczema Severity Index score from baseline to week 12 compared to alitretinoin capsules.
The candidate also demonstrated superiority to alitretinoin capsules in all key secondary outcome measures.