Recruitment begins in Ph III trial of Medicure's MC-1

Medicure, a Canadian cardiovascular-focused biopharmaceutical company, has commenced enrollment in a Phase III study that will evaluate the cardioprotective effects of its US Food and Drug Administration-fast tracked drug candidate, MC-1, in approximately 3,000 patients undergoing coronary artery bypass graft surgery.

The news, which broke on November 17, prompted rumors that the small Manitoba-headquartered drugmaker could be a takeover taget. There are currently no approved cardioprotective products to reduce CV events after CABG surgery so MC-1 could be the first product on the market to help the hundreds of thousands of patients who undergo this type of surgery every year. Shares in Medicure rose more than 13% in pre-market activity on the morning of the announcement.

The double-blind, randomized, placebo-controlled trial will enroll up to 3,000 patients undergoing CABG surgery at approximately 120 cardiac surgical centers throughout North America and Europe. In the US FDA-approved study design, patients will be randomized to receive placebo or MC-1 250mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint is reduction in the composite of CV death and non-fatal myocardial infarction up to POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis, Medicure noted.