MC2 Therapeutics has reported positive top-line results from a Phase lll trial to investigate the efficacy and safety of MC2-01 Cream compared to MC2-01 vehicle and Taclonex for the treatment of subjects with psoriasis vulgaris.
The randomised, multicentre, investigator-blind, parallel-group trial included 796 patients at 55 dermatologists across the US.
During the trial, the patients applied trial medication topically once daily for eight weeks.
The trial’s primary goal was to demonstrate therapeutic non-inferiority of MC2-01 Cream to the active comparator, as well as characterise the safety of MC2-01 Cream in the psoriasis vulgaris patients.
Its primary efficacy endpoint included the proportion of subjects in each treatment group with ‘treatment success’ at week eight, defined as a minimum two-point decrease from baseline in physician global assessment (PGA) score.
The top-line results showed that the trial met its primary goal.
It was also found that MC2-01 Cream offered a 60.2% reduction in itch at week four as measured by the frequency of a four-grade or greater improvement on an 11-point numeric rating scale of itch severity.
The trial reported adverse events that were predictable pharmacological class effects typically associated with calcipotriene and topical corticosteroids.
In addition, the safety profile of MC2-01 cream was found to be similar to that of Taclonex.
The trial lead investigator Linda Stein Gold said: “The significant improvements in both treatment success and patient reported treatment convenience are particularly encouraging.
“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.”
Psoriasis is a lifelong condition that considerably impacts patients’ quality of life.