MC2-01 Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) from MC2 Therapeutics A/S achieved its primary and secondary endpoints, according to recently reported top-line data from the US Phase 3 study.
Results of the phase 3 study (n=796) show that 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.
MC2-01 Cream achieved secondary endpoints, showing superiority to Taclonex based on percentage reduction in mPASI from baseline to Week 8 (64.8% versus 52.3%, p < 0.0001) and superiority to Taclonex® in Patient Treatment Convenience (p < 0.0001). MC2-01 Cream provided 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,” says 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.”
Adverse events seen in the trial were predictable pharmacological class effects typically associated with calcipotriene and topical corticosteroids. The safety profile of MC2-01 cream was similar to that known for Taclonex.