Medicure moves cardiovascular drug MC-1 into phase 3 study

By E. Janene Geiss

Philadelphia, Dec. 5 - Medicure Inc. said its phase 2 MEND-CABG study of the Food and Drug Administration fast-tracked cardioprotective product MC-1 yielded positive results.

Based on the results, the company said it plans to move forward with a pivotal phase 3 clinical development program for MC-1, officials said in a news release.

The MEND-CABG study is a double blind, parallel group, randomized, placebo-controlled study of 901 patients who underwent coronary artery bypass graft surgery.

The MEND-CABG results demonstrate the positive clinical effects of MC-1, including:

• The 250 mg 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 the 250 mg of MC-1 versus placebo;

• The 250 mg dose of MC-1 had a 14% reduction in the primary endpoint composite of death, non-fatal myocardial infarction and non-fatal stroke versus placebo;

• The 250 mg dose of MC-1 had a 78.7% reduction in physician-diagnosed myocardial infarctions versus placebo and;

• Greater efficacy was demonstrated with the 250 mg dose than the 750 mg dose of MC-1.

"The strong efficacy signal observed with MC-1 in MEND-CABG, highlighted by the statistically significant reduction in heart attacks, have exceeded our expectations and clearly warrant advancing MC-1 into pivotal phase 3 development," said Albert D. Friesen, president and chief executive officer, in the release.

"The results also provide us with the necessary information to design the phase 3 study, including the dosing and endpoints. We now plan on meeting with the FDA to discuss these results and develop the phase 3 program," Friesen added.

The company said it also expects these results to accelerate ongoing discussions with potential partners.

Medicure is a New York City cardiovascular drug discovery and development company.

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