- First patient dosed in Phase 3 trial assessing the safety and efficacy of MC2-01 Cream in EU
- Topline results are expected in Q3 2019
Copenhagen, January 6th, 2019 – MC2 Therapeutics A/S, a late-stage topical therapies company today announced that the first patients have been dosed in its EU Phase 3 clinical trial assessing the safety and efficacy of MC2-01 Cream compared to MC2-01 vehicle and active comparator for the treatment of plaque psoriasis in adult patients. MC2-01 Cream is an innovative fixed-dose combination of calcipotriene and betamethasone dipropionate (0.005%/0.064% w/w) enabled by MC2 Therapeutics’ proprietary PAD™ Technology.
“The initiation of the Phase 3 trial of MC2-01 Cream in EU is another important milestone in the development of MC2-01 Cream in various territories and in our efforts to introduce a new standard of topical therapies for people with chronic inflammatory conditions,” says Jesper J. Lange, President and CEO of MC2 Therapeutics. “The very positive results that we have seen with MC2-01 Cream in our US Phase 3 trial, where we demonstrated statistically significant higher efficacy of MC2-01 Cream versus Taclonex® Topical Suspension, support our rationale that PAD™ Technology enables a new standard of topical therapies where high efficacy and patient convenience are combined, thereby addressing the needs of patients in daily routines – a life companion for people living with chronic skin diseases.”
About the MC2-01 EU Phase 3 Trial
The trial is a Phase 3, randomized, multicenter, investigator-blind, parallel-group trial in subjects with psoriasis vulgaris. The trial is expected to enroll approximately 476 patients in about 34 centers across Europe. Subjects will apply trial medication topically once daily for up to 8 weeks.
The primary objective is to compare therapeutic efficacy of MC2-01 Cream versus active comparator, as well as to characterize the safety profile of MC2-01 Cream in subjects with psoriasis vulgaris. The primary efficacy endpoint is the percentage change in mPASI score from Baseline to Week 8. Secondary endpoints will be assessed including treatment success according to Physician Global Assessment and patient acceptability of treatments on a Psoriasis Treatment Convenience Scale.
Topline results are expected in Q3 2019 and will constitute the basis for a MAA submission.
Psoriasis is an immune-mediated, inflammatory condition of the skin affecting nearly 3% of the world’s population. As a chronic disease psoriasis has a substantial impact on the quality of life of patients. Psoriasis symptoms can vary but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed. More than 80% of patients have mild to moderate psoriasis, where topical therapies are first line of treatment.
About MC2 Therapeutics A/S
MC2 Therapeutics A/S is a privately held late-stage topical therapies company focusing on chronic inflammatory conditions. Using its proprietary PAD™ Technology – a new class of vehicle – MC2 Therapeutics is developing a pipeline of new highly efficacious topical therapies designed for unique patient experiences.