April 13, 2010 (FinancialWire) — Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) said the results of the M118 Eminence clinical trial published in Circulation, conclude the drug was "well-tolerated."

The paper, entitled "Evaluation of a New Heparin Agent in Percutaneous Coronary Intervention: Results of the Phase 2 Evaluation of M118 in Percutaneous Coronary Intervention (Eminence) Trial published in the April 5, 2010 "Publish Ahead of Print" online edition of the peer-reviewed journal Circulation: Journal of the American Heart Association.

The key conclusion in the paper is that in this study M118 was well-tolerated and provided further evidence of feasibility for use as an anticoagulant in patients undergoing elective percutaneous coronary intervention. The authors further conclude the data provides the basis for further investigations of M118 in ischemic heart disease. The first author was Sunil V. Rao, M.D., co-principal investigator for the Eminence trial. Dr. Rao is an Assistant Professor of Medicine at the Duke University Medical Center and director of the Cardiac Catheterization Laboratories at the Durham, NC Veterans Affairs Medical Center.

The Eminence trial was designed to evaluate the utility of M118 in patients with stable angina undergoing an elective PCI. Patients scheduled to undergo elective PCI, who met study eligibility criteria and for whom use of a glycoprotein IIb/IIIa inhibitor was not intended, were randomly assigned to treatment with 1 of 3 doses (50 IU/kg, 75 IU/kg, or 100 IU/kg) of intravenous M118, or a standard unfractionated heparin dose of 70 U/kg. Patients were also treated with at least 325 mg of aspirin and at least 300 mg of clopidogrel before PCI. The study was originally planned to include 150 patients in each arm, for a total of 600 patients. Enrollment into the lowest dose (50 IU/kg) was discontinued based on a recommendation by the Data Safety Monitoring Board, and consequently, approximately 500 patients in total were enrolled (44, 152, 156, patients enrolled in the 50 IU/kg, 75 IU/kg, and 100 IU/kg M118 arms respectively, and 151 patients in the 70 U/kg UFH arm).

The primary objective of Eminence was to evaluate the safety and feasibility of utilizing M118 as an anticoagulant in the target population of patients with stable CAD undergoing a PCI. A secondary objective was to evaluate the effect of M118 on procedural indices, including procedure success, abrupt closure, post-procedural Thrombosis in Myocardial Infarction flow grade, and catheter thrombus.

M118 is an anticoagulant that has been rationally engineered using Momenta's proprietary technology and analytical methods to provide anticoagulant therapy to patients with acute coronary syndrome. M118 was designed to interact at multiple points in the coagulation cascade by selectively binding to both anti-thrombin III and thrombin, two critical factors involved in the formation of clots.

Momenta Pharmaceuticals is a biotechnology company, headquartered in Cambridge, MA, specializing in the detailed structural analysis of complex mixture drugs. Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs.

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