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Momenta Pharmaceuticals Initiates Phase-1 Study for M118 Subcutaneous Formulation

[M118 is MNTA’s lead proprietary drug candidate. (MNTA’s other programs are for generic drugs.) M118 is intended to take the best features of unfractionated heparin, LMW heparin, and direct thrombin inhibitors, while omitting the worst features of each. FXa intervention (Lovenox and other LMH heparins) works great for preventing DVT, but it is ineffective on arterial thrombosis, is not reversible, and is rarely used in the cath lab. FIIa intervention (Angiomax) works great for preventing arterial thrombosis, but it is ineffective against DVT and impractical for chronic use. Unfractionated heparin inhibits both FXa and FIIa and is reversible, but it has problems with monitoring and reliability. M118 works on both FXa and FIIa, is reversible, and doesn’t have the monitoring and reliability problems of heparin. If it works as advertised it will be a monumental blockbuster, but it’s still very early in development. ACS is the lead indication and stable angina is a planned secondary indication.]

http://biz.yahoo.com/pz/070514/119461.html

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Monday May 14, 9:20 am ET

CAMBRIDGE, Mass., May 14, 2007 (PRIME NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NasdaqGM: MNTA ), a biotechnology company specializing in the characterization and engineering of complex drugs, announced today that the Company has initiated dosing of its Phase I study to evaluate the human safety, tolerability, bioavailability and pharmacokinetics of a subcutaneous formulation of M118, the Company's lead novel development candidate. M118 is a next-generation anticoagulant designed specifically for use in treating patients diagnosed with acute coronary syndromes (ACS). An IND for the subcutaneous formulation was submitted in April to and cleared by the Division of Cardiovascular and Renal Products within the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER).

``We anticipate that an important feature of M118 will be flexibility to follow ACS patients through the treatment path most appropriate for each individual,' said Craig A. Wheeler, President and Chief Executive Officer of Momenta. ``A key facet of our plan to accomplish this is our intention to develop multiple formulations of M118 for both intravenous and subcutaneous administration.'

At the American College of Cardiology 56th Annual Scientific Session in March, Momenta announced that M118 administered intravenously demonstrated superior efficacy to a standard dose of unfractionated heparin (UFH) in a preclinical model of acute arterial thrombosis. In the preclinical study, a dose of M118, matched on the basis of anticoagulant activity with a standard UFH dose used in clinical practice, demonstrated superior efficacy in preventing occlusion of an injured artery. This increase in efficacy did not result in an increased risk of bleeding. Previous preclinical studies have shown M118 to be at least as effective as UFH in inhibiting clot formation without causing increased bleeding complications. Additionally, the study also demonstrated that the level of anticoagulation provided by M118 can be readily monitored using standard point-of-care coagulation assays.

Trial Details

In the Phase I trial, Momenta expects to enroll healthy adult volunteers. M118 or a placebo will be administered as a subcutaneous injection in single ascending doses to up to six cohorts. One pre-specified cohort will also receive the same dose of M118 intravenously for determination of the absolute bioavailability of the subcutaneous formulation. M118 will also be evaluated for its safety, tolerability and pharmacokinetic profile. Pending the outcome of the single dose ascending study, Momenta anticipates conducting subsequent Phase I studies with the subcutaneous formulation of M118, including a multiple ascending dose study, which is designed to simulate the intended use of the M118 subcutaneous injection in clinical practice.

About M118

M118 is a next-generation heparin drug candidate that has been, through Momenta's proprietary technology, rationally engineered to provide anticoagulant therapy to patients with ACS. M118 is designed to interact at multiple points in the coagulation cascade by selectively binding to anti-thrombin III and thrombin, two critical factors in the formation of clots. In preclinical studies, data have shown that M118 is a potent inhibitor of multiple factors in the blood that lead to clot formation, its effects can be reversed or neutralized and its activity can be monitored, addressing the current unmet medical need within the ACS marketplace.

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 there are more than 1.5 million occurrences of either unstable angina or myocardial infarction requiring medical treatment across the U.S. 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 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. The Company's most advanced product candidate, M-Enoxaparin, is designed to be a technology-enabled generic version of Lovenox(r). Momenta's first novel drug candidate is M118, a rationally engineered anticoagulant specifically designed for acute coronary syndromes. Through its discovery program, the Company is seeking to discover and develop novel therapeutics by applying its technology to better understand sugars' functions in biological processes, with an initial focus in oncology. Momenta was founded in 2001 based on technology initially developed at Massachusetts Institute of Technology and is headquartered in Cambridge, MA.
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