- Topline results are expected in Q3 2018
Copenhagen, April 2nd, 2018 – MC2 Therapeutics A/S, a clinical-stage dermatology and eye care company today announced that the patient enrollment for the Phase 3 clinical trial assessing the safety and efficacy of MC2-01 PAD ™ Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for the treatment of plaque psoriasis in adult patients, has been finalized.
“Completion of patient enrollment in this Phase 3 registration trial marks a significant and timely accomplishment for the MC2-01 development program” stated Jesper J. Lange, President of MC2 Therapeutics. He added “We are committed to use our proprietary PAD ™ Technology – a new class of vehicle – to release the full potential of potent and safe API’s for topical applications. If the results are positive, the trial will form the basis for submission of a New Drug Application planned for 1H 2019”.
About the MC2-01 Phase 3 Trial
The trial is a Phase 3, randomized, multicenter, investigator-blind, parallel-group trial to evaluate the efficacy and safety of MC2-01 Cream compared to MC2-01 vehicle and active comparator in subjects with psoriasis vulgaris. The trial enrolled approximately 791 patients in about 57 centers across the United States. Subjects apply trial medication topically once daily for up to 8 weeks.
The primary objective is to show therapeutic non-inferiority of MC2-01 Cream to 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 proportion of subjects in each treatment group with “treatment success” at Week 8, defined as a minimum 2-point decrease from Baseline to Week 8 in PGA score; i.e. a score of 0 (clear) or 1 (almost clear) disease for subjects with moderate disease at Baseline; or a score of 0 (absent) for subjects with mild disease at Baseline.
Topline results are expected in Q3 2018.
About MC2 Therapeutics A/S
MC2 Therapeutics A/S is a privately held clinical-stage dermatology and eye care company. 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.