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news.Medicure's cardio-protective agent MC-1 has produced positive results in a phase II trial evaluating the effects of the drug in 901 patients who underwent coronary artery bypass graft surgery.
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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.