- Topline data are expected in Q4 2019
Copenhagen, August 7th, 2019 – MC2 Therapeutics A/S, a late clinical-stage pharmaceutical company focused on topical therapies for chronic inflammatory conditions, today announced the completion of enrollment for its EU Phase 3 study assessing the safety and efficacy of MC2-01 PAD ™ Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) in adult patients with plaque psoriasis compared to Daivobet® gel (marketed in the US as Taclonex® Topical Suspension).
“Completion of patient enrollment in this EU Phase 3 registration study marks yet another significant and timely accomplishment for the MC2-01 PAD ™ Cream global development program in plaque psoriasis following our successful US Phase 3 head-to-head study in 2018,” stated Jesper J. Lange, CEO & President of MC2 Therapeutics. He added: “Our efforts in both EU and US demonstrate that we are committed to build leadership in topical therapies for patients with chronic inflammatory conditions. 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 moisturizing and cosmetic feel that we believe will significantly upgrade the patient experience and convenience in daily routines.”
About the MC2-01 PAD ™ Cream Phase 3 Study
The study is a Phase 3, randomized, multicenter, investigator-blind, parallel-group study to evaluate the efficacy and safety of MC2-01 PAD ™ Cream in subjects with plaque psoriasis compared to MC2-01 vehicle and Daivobet® gel. Subjects apply study medication topically once daily for up to 8 weeks. The primary objective is to show therapeutic superiority of MC2-01 PAD ™ Cream to the active comparator, as well as to characterize the safety profile of MC2-01 PAD ™ Cream in subjects with plaque psoriasis. The primary efficacy endpoint is percentage change from baseline in mPASI on the body at Week 8. The study enrolled 490 patients in 32 centres in Europe.
About MC2 Therapeutics A/S
MC2 Therapeutics A/S is a privately held late clinical-stage pharmaceutical company focused on topical therapies for chronic inflammatory conditions. Using its proprietary PAD ™ Technology – a unique oil-in-water dispersion – MC2 Therapeutics is developing a pipeline of novel innovative topical therapies designed for unique patient experiences.