MC2 Therapeutics has completed enrollment for its Phase III study of MC2-01 PAD Cream to treat adult patients with plaque psoriasis.
The randomised, multi-centre, investigator-blind, parallel-group MC2-01 PAD Cream study will assess the safety and efficacy of the cream compared to MC2-01 vehicle and Daivobet gel.
MC2 Therapeutics CEO and president Jesper Lange said: “Completion of patient enrolment in this EU Phase III registration study marks yet another significant and timely accomplishment for the MC2-01 PAD Cream global development programme in plaque psoriasis following our successful US Phase III head-to-head study in 2018.
“Our proprietary PAD Technology enables us to develop a new standard of topical therapies that combine fast and effective relief of symptoms with a unique moisturising and cosmetic feel that we believe will significantly upgrade the patient experience and convenience in daily routines.”
As part of the study, which enrolled 490 patients in 32 centres across Europe, subjects apply medication topically once daily for up to eight weeks.
The trial’s primary objective is to show therapeutic superiority of MC2-01 PAD Cream to the active comparator and to characterise the safety profile of the cream in subjects with plaque psoriasis.
Primary efficacy endpoint is a percentage change from baseline in mPASI on the body at week eight.
Topline results of the study are expected in the fourth quarter of this year.
In August last year, MC2 Therapeutics reported positive top-line results from a Phase lll trial of MC2-01 Cream compared to MC2-01 vehicle and Taclonex for the treatment of subjects with psoriasis vulgaris.
The randomised, multi-centre, investigator-blind, parallel-group trial included 796 patients at 55 dermatologists across the US.