Based on the positive results of the trial, the company now plans to move forward with a pivotal phase III clinical development program for MC-1.
In the trial a 250mg dose of MC-1 had a 37.2% reduction in the composite of death, non-fatal myocardial infarction, and non-fatal stroke versus placebo.
The reduction in the composite endpoint was driven by a substantial decrease in the incidence of non-fatal myocardial infarction, most notably a 46.9% reduction in non-fatal myocardial infarction with 250mg of MC-1 versus placebo.
According to the study data, greater efficacy was demonstrated with the 250 mg dose than the 750mg dose of MC-1.
“The results clearly suggest that patients treated with MC-1 experienced clinically meaningful reductions in the composite endpoint, driven by a pronounced reduction in non-fatal myocardial infarctions, which comprise the majority of events after CABG surgery,” commented the principal investigator for the trial, Dr Jean-Claude Tardif, director of the Research Centre, Montreal Heart Institute.