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Momenta Pharmaceuticals Announces Top-Line Results From the M118 EMINENCE Trial
4:29 pm ET 06/29/2009 - GlobeNewswire
CAMBRIDGE, Mass., June 29, 2009 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced top-line results from the EMINENCE (Evaluation of M118 in Percutaneous Coronary Intervention) phase 2 multicenter study of the intravenous formulation of M118.

EMINENCE was designed to evaluate the safety and feasibility of utilizing M118 as an anticoagulant in the target population of patients with stable coronary artery disease (CAD) undergoing a percutaneous coronary intervention (PCI). Approximately 500 patients with stable coronary artery disease undergoing elective PCI were randomly assigned to receive treatment with one of three doses of intravenous M118 or a standard dose of unfractionated heparin (UFH).

The primary endpoint of the study was the combined incidence of clinical events defined as the composite of death, myocardial infarction, repeat revascularization, and stroke (over thirty days); incidence of bleeding and thrombocytopenia (over the first 24 hours); and bailout use of glycoprotein IIb/IIIa inhibitors and catheter thrombus (during the procedure). The primary analysis in the study provided evidence of non-inferiority of the combined M118 group (combining all three doses) as compared to the UFH group within the parameters of the prospectively defined analysis. The observed incidence of the composite endpoint was lower in all M118 treatment groups than in the UFH group; however it should be noted that the study was not designed or powered to detect statistically significant differences between treatments. The incidence of serious and non-serious adverse events was comparable in all treatment groups.

The EMINENCE trial was conducted in collaboration with the Duke Clinical Research Institute (DCRI). "Considering the relatively high incidence of event rates that we continue to observe in ACS clinical trials, it is important to continue to carefully evaluate investigational compounds in the search for better alternatives," stated Dr. Robert Harrington, Director of the DCRI. "While it is encouraging that the EMINENCE trial met its primary endpoint in this phase 2 study, it will be critically important - as is the case with any promising compound in development - to carefully study both efficacy and safety in larger clinical trials to better characterize its clinical potential."

"With the successful completion of EMINENCE, the first M118 trial conducted in patients with coronary artery disease, we have achieved an important milestone in the M118 development program. We believe these results are supportive of the proof of principle that a novel, rationally designed low molecular weight heparin could potentially address some of the limitations of currently available therapy in patients with ACS, and hope to present the comprehensive trial results at an appropriate scientific forum later in the year," commented Jim Roach, M.D., Chief Medical Officer at Momenta.

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