August 21, 2018

MC2 Therapeutics A/S announces positive top-line results from Phase 3 clinical trial comparing MC2-01 Cream to Taclonex® in adults with psoriasis

MC2-01 Cream demonstrates statistically significant superiority in both treatment success and patient reported treatment convenience compared to Taclonex® Topical Suspension. Both primary and secondary endpoints were met and a submission of NDA to the FDA is now planned for H1 2019.

Copenhagen, August 21st, 2018 – MC2 Therapeutics A/S, an emerging pharmaceutical company developing next generation patient-friendly topical therapies for skin and eye diseases, today announced the following top-line data from its US Phase 3 study (n=796) on the company’s investigational drug, MC2-01 Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%):

Primary end-point

  • MC2-01 Cream is superior to Taclonex® Topical Suspension (“Taclonex®”) at Week 8 based on treatment success defined as a minimum two-point decrease in the Physician Global Assessment (PGA) score (40.1% versus 24.0%, p < 0.0001). Accordingly, the trial met its primary endpoint to demonstrate non-inferiority of MC2-01 Cream to Taclonex®.

Secondary endpoints

  • MC2-01 Cream is superior to Taclonex® based on percentage reduction in mPASI from baseline to Week 8 (64.8% versus 52.3%, p < 0.0001) (MC2-01 Cream demonstrated fast onset of action with superiority (p < 0.001) to Taclonex® already at Week 1).
  • MC2-01 Cream is superior to Taclonex® in Patient Treatment Convenience (p < 0.0001)
  • MC2-01 Cream provides a robust reduction in itch (60.2% at Week 4) measured by the frequency of a four-grade or greater improvement on an 11-point numeric rating scale of itch severity.

“The significant improvements in both treatment success and patient reported treatment convenience are particularly encouraging,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and lead investigator in the study. “Enhanced patient satisfaction enabled by the MC2-01 Cream PAD ™ formulation may increase treatment compliance among patients, and positively impact real-life treatment outcomes even further. As such PAD ™ Technology holds the promise of redefining topicals.”

The adverse events seen in the trial were predictable pharmacological class effects typically associated with calcipotriene and topical corticosteroids, and the safety profile of MC2-01 cream was similar to that known from Taclonex®.

MC2 Therapeutics is pursuing a patient-centric approach to treating psoriasis by developing a once-daily, non-greasy topical treatment that can be conveniently applied to a large surface area of the body and absorbs quickly into the skin to provide rapid symptom relief. MC2-01 Cream is designed to allow patients to comfortably wear clothes immediately after application and go about their daily routines.

“We are extremely pleased with these superiority data from the head-to-head study of MC2-01 Cream versus Taclonex®, which is widely regarded as a first line topical treatment of psoriasis,” stated Jesper J. Lange, President of MC2 Therapeutics. “Psoriasis is a life-long condition that significantly impacts patients’ quality of life. MC2-01 Cream is designed to provide patients a new standard of care for the topical treatment of psoriasis that helps them effectively and conveniently manage their condition and minimize disruption to their daily routine and social interactions.”

Lange added, “These data confirm the tremendous potential for PAD ™ Technology as a broad platform for the development of new topical drugs that releases the full potential of the active ingredients, while being very pleasant to use for patients in daily routines. PAD ™ Technology enables an expanded formulation space that opens the door for an array of new topical therapies that might not otherwise be developed e.g. due to challenges with delivery, solubility and stability of active ingredients.”

About the MC2-01 Phase 3 Trial

This Phase 3, randomized, multicenter, investigator-blind, parallel-group trial evaluated the efficacy and safety of MC2-01 Cream compared to MC2-01 vehicle and the active comparator (Taclonex®) in subjects with psoriasis vulgaris. The trial enrolled 796 patients at 55 dermatologists across the United States. Subjects applied trial medication topically once daily for eight weeks.

The primary objective was to show therapeutic non-inferiority of MC2-01 Cream to the active comparator, as well as to characterize the safety profile of MC2-01 Cream in subjects with psoriasis vulgaris. The primary efficacy endpoint was the proportion of subjects in each treatment group with “treatment success” at week eight, defined as a minimum two-point decrease from baseline 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).

The full data from the trial will be presented at upcoming medical conferences. Global development of MC2-01 will continue and MC2 Therapeutics plans to submit a New Drug Application (NDA) to FDA in the first half of 2019.

About MC2 Therapeutics A/S

MC2 Therapeutics A/S is a privately held pharmaceutical company that is applying its proprietary PAD ™ Technology as a broad platform to enable the development of a new generation of patient friendly topical prescriptions and consumer healthcare products. The Company is advancing its own portfolio of products to treat skin and eye conditions and is collaborating with other pharmaceutical companies to unlock the full potential of their active pharmaceutical ingredients in new topical drug candidates.