MC2 Therapeutics A/S, a clinical-stage dermatology and eye care company today announced that first patient has been dosed in its pivotal Phase 3 clinical trial assessing the safety and efficacy of MC2-01 Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) compared to MC2-01 vehicle and an active comparator for the treatment of plaque psoriasis in adult patients.
“The initiation of the Phase 3 trial of MC2-01 Cream is a significant milestone in the development of MC2-01 Cream across territories and in our efforts to introduce a new standard of topical therapies,”says Jesper J. Lange, President of MC2 Therapeutics. “We are encouraged by the results that we have seen to date with MC2-01, which is based on our proprietary PAD™ Technology – a new class of vehicle. Psoriasis is a chronic condition that affects the daily lives of millions of people. MC2-01 Cream is a new topical treatment designed with 100% focus on the acute and long-term needs of patients. It quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on in daily routines – a life companion for people living with psoriasis.”
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 is expected to enroll approximately 790 patients in about 57 centers across the United States. Subjects will 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. A variety of secondary endpoints will be assessed including patient acceptability of treatments on a Psoriasis Treatment Convenience Scale.
Topline results are expected in Q3 2018 and will constitute the basis for an NDA submission.