CAMBRIDGE, Mass., Oct. 10 /PRNewswire-FirstCall/ -- Momenta Pharmaceuticals, Inc. , a biotechnology company specializing in the characterization and engineering of complex drugs, announced today that the Company has initiated dosing for its Phase I study to evaluate the human safety and pharmacokinetics 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).
"We designed M118 to combine the most attractive properties of different heparin products into one molecule," said Craig A. Wheeler, President and Chief Executive Officer of Momenta. "Our preclinical studies have shown that M118 could be a potent agent that provides consistent, flexible and reversible anticoagulant therapy. We believe that M118 has the opportunity to be a future baseline anticoagulant therapy for ACS patients."
"The clinical dosing of M118 highlights a major milestone for Momenta. M118 is the first novel therapeutic derived from the application of our technology to rational design and development of therapeutics," continued Mr. Wheeler. "We see great promise for further application of our technology to design other novel heparin and protein-based therapies."
Trial Details
In the Phase I trial, Momenta expects to enroll up to 36 healthy adult male volunteers. M118 or a placebo will be administered as a single intravenous bolus in single ascending doses to cohorts of six subjects. M118 will be evaluated for its safety, tolerability and pharmacokinetic profile. Momenta expects to have preliminary results from this study in the first half of 2007.
Background on M118
Momenta engineered M118 using its proprietary technology for performing detailed analysis and design of complex sugar therapeutics such as heparins. By isolating, characterizing and engineering the key sugar structures within heparin that contribute to anticoagulation and other important properties, Momenta engineered a proprietary compound that has shown in preclinical studies an effective combination of the binding sites critical for anticoagulation, as well as monitorability and reversibility.
This combination of properties results in a flexible anticoagulant which the Company believes could provide a baseline anticoagulant therapy to treat both those ACS patients who require a percutaneous coronary intervention, as well as those ACS patients who are medically managed or do not require intervention in order to treat their coronary attack. In addition, the Company also anticipates that the compound should have a more predictable pharmacokinetic profile than heparin, similar to a low molecular weight heparin.
Pre-Clinical Data
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, M118 has been shown to be at least as effective as unfractionated heparin in inhibiting clot formation without causing increased bleeding complications. Moreover, preclinical studies have shown that M118's anticoagulant activity was reversible by protamine sulfate, unlike currently marketed low molecular weight heparins or direct thrombin inhibitors. Finally, the preclinical studies also demonstrated that the level of anticoagulation provided by M118 can be readily monitored using standard point-of-care coagulation assays.
Background on 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 1.9 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 characterization and engineering of complex sugars. Momenta is applying its technology to create technology-enabled generic versions of sugar-based and other complex drug products, develop improved versions of existing drugs, and discover novel drugs and new biological processes. The Company's most advanced product candidate is M-Enoxaparin, a technology-enabled generic version of Lovenox(R). Momenta's first improved drug candidate is M118, a rationally engineered anticoagulant specifically designed for acute coronary syndromes. The Company is developing other novel drug candidates through its discovery effort focused on understanding sugar-based biological processes. Momenta was founded in 2001 based on technology initially developed at Massachusetts Institute of Technology and is headquartered in Cambridge, MA.
To receive additional information about Momenta, please visit the website at http://www.momentapharma.com, which does not form a part of this press release.
Forward Looking Statements
Statements in this press release regarding Momenta Pharmaceuticals Inc.'s future expectations, beliefs, intentions, goals, strategies, plans or prospects may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company's M118 product candidate, its product pipeline, and future growth and opportunities. Momenta's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including those factors contained in Momenta's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. Forward-looking statements include statements regarding Momenta's expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "should", "will", and "would" or similar words. Momenta assumes no obligations to update the information included in this press release.
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Momenta Contacts: Michael Lawless Investor Relations 617-395-5189 Valerie Threlfall Media Relations 617-395-5116
Momenta Pharmaceuticals, Inc.CONTACT: Michael Lawless, Investor Relations, +1-617-395-5189, or ValerieThrelfall, Media Relations, +1-617-395-5116, both of MomentaPharmaceuticals, Inc.
Web site: http://www.momentapharma.com/
