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Momenta Pharmaceuticals announced top-line results from the EMINENCE (Evaluation of M118 in Percutaneous Coronary Intervention) phase 2 multicenter study of the intravenous formulation of M118
CAMBRIDGE, MA, USA | June 29, 2009 | Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA - News), 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.
About M118
M118 is a novel anticoagulant that has been rationally engineered using Momenta's proprietary technology and analytical methods to provide anticoagulant therapy to patients with acute coronary syndrome (ACS). M118 is 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. Preclinical and phase 1 studies have shown that M118 is a potent inhibitor of multiple factors in the blood that lead to clot formation, that its anticoagulant effects can be neutralized and that its activity can be monitored with standard point-of-care assays. An anticoagulant possessing these properties has the potential to satisfy a currently unmet medical need within the ACS patient population by capturing, in a single anticoagulant therapy, the positive attributes of both UFH (reversibility, monitorability and broad inhibition of the coagulation cascade) and low molecular weight heparins (adequate bioavailability and predictable pharmacokinetics to allow for convenient subcutaneous administration). M118 is designed to be an anticoagulant that could potentially be used in multiple settings, including initial medical management of ACS, angioplasty or coronary artery bypass surgery.
About Acute Coronary Syndromes
ACS is characteristically used to describe patients experiencing an acute myocardial infarction, or heart attack, as well as patients who present at hospitals with unstable angina, a transient blockage of a coronary artery. According to the National Hospital Discharge Survey, each year in the United States there are more than 1.5 million occurrences of either unstable angina or myocardial infarction requiring medical treatment. As part of the treatment of ACS, anticoagulant agents are routinely administered to prevent the accumulation and formation of blood clots which can lead to serious, life-threatening complications.
About Momenta
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.
To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.
SOURCE: Momenta Pharmaceuticals, Inc. |
