Top line data from phase III trial of MC2 01 cream to treat psoriasis.- MC2 Therapeutics A/S.

MC2 Therapeutics A/S, an emerging pharmaceutical company developing next generation patient-friendly topical therapies for skin and eye diseases, announced the following top-line data from its US Phase III 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 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 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.

Comment: 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.

Comment: A formulation that is easier to apply could improve compliance and thus efficacy. Some research has shown as many as 73% of patients on topical drugs for psoriasis do not comply with their treatment, according to the company..