Biotechnology company Momenta Pharmaceuticals, Inc. (MNTA), Thursday revealed positive results from the EMINENCE Phase II multicenter trial evaluating intravenous use of anticoagulant, M118. The company said the trail met the end point of supporting the feasibility and tolerability of M118 use as a procedural anticoagulant in the coronary catheterization laboratory.
M118 is designed to capture the positive attributes of both unfractionated heparin and low molecular weight heparin. Momenta said results from the EMINENCE or Evaluation of M118 in Percutaneous Coronary Intervention trial showed potential to become the baseline anticoagulant of choice for treatment of patients diagnosed with acute coronary syndromes.
The primary objective of the trial was to evaluate the safety and feasibility of utilizing M118 as an anticoagulant in the target population of patients with stable coronary artery disease or CAD, who are also undergoing a percutaneous coronary intervention or PCI.
Approximately 500 patients with stable CAD undergoing elective PCI were randomly assigned to receive treatment with one of three doses of intravenous M118 or a standard dose of unfractionated heparin or UFH.
The company said primary endpoint of the study was the combined incidence of clinical events defined as the composite of death, myocardial infarction or MI, repeat revascularization, and stroke - over thirty days- and incidence of bleeding and thrombocytopenia - over the first 24 hours, and bailout use of glycoprotein IIb/IIIa inhibitors and catheter thrombus during the procedure.
Safety was also evaluated, assessing the incidence of adverse events and serious adverse events. The most common serious adverse events overall were investigator-identified MI - 2.6%, angina pectoris - 1.2%, noncardiac chest pain - 1.2%, and unstable angina - 0.8%.
MNTA is currently trading at $10.83, down $0.05 or 0.46%, on a volume of 1.689 million shares on the Nasdaq.
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