CAMBRIDGE, Mass., April 4, 2008 (PRIME NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, announced today that clinical data from a Phase 1 study of M118, the Company's rationally engineered anticoagulant, will be presented at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting in Orlando, FL, today at 7:00 a.m. by Ian Fier, Vice President of Development Operations at Momenta and Project Leader of the M118 development program. The poster, entitled: "Pharmacokinetic and Pharmacodynamic Properties of M118, a Novel, Rationally Engineered Low Molecular Weight Heparin, Following IV Injection in Human Volunteers," will be presented during Poster Session II (PII-59).
One of the key findings from the study was that an Activated Clotting Time (ACT) reading of greater than 200 seconds was achieved in the higher dose cohorts, suggesting that an intravenous bolus administration of M118 can produce ACT levels comparable to levels expected with standard heparin doses used in conjunction with Percutaneous Coronary Intervention (PCI) procedures. The Company announced top line results from this trial on October 11, 2007.
"The results from our Phase 1 program to date have demonstrated that intravenously administered M118 has been well tolerated and has demonstrated rapid, measurable, and predictable dose-dependent increases in anticoagulant activity," stated Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer at Momenta. "Additionally, our Phase 1 results also suggest that M118 can be effectively reversed with protamine sulfate and may also be concomitantly administered with medications commonly prescribed for the treatment of Acute Coronary Syndromes including aspirin, clopidogrel, and GP IIb/IIIa inhibitors. Based on these product attributes, and provided that further robust controlled clinical trials confirm and extend these results, we believe that M118 has the possibility to be differentiated from other antithrombotic agents. We continue to actively enroll patients in our ongoing Phase 2a trial, and look forward to reporting results later in the year."
The multi-center Phase 2a trial, or EMINENCE (Evaluation on M118 IN pErcutaNeous Coronary IntErvention), is expected to enroll approximately 600 patients who are planning to undergo a PCI, and will evaluate the use of M118 as a procedural anticoagulant.
Study Design
The Phase 1 study of intravenously administered M118 enrolled 36 healthy male volunteers. All were admitted to a Phase 1 clinic for 24 hours. Subjects were administered escalating IV bolus doses of M118 (6, 12.5, 25, 50, 75, 100 anti-Factor Xa (aXa) IU/kg) in cohorts of 6 subjects, 4 active and 2 placebo (saline) per cohort. Pharmacokinetic and pharmacodynamic parameters were measured for all dose groups, including point-of-care monitoring via ACT, which is the most prevalent measure of anticoagulant levels in the coronary catheterization laboratory. Blood samples for determination of ACT, aPTT, anti-Factors Xa and IIa activity, and other safety labs were collected through 24h post-dose.
Study Results
Changes in ACT from baseline with the dose of M118 were highly correlated (R2 = .996) and appeared to increase in a dose-proportional fashion from 25 to 100 aXa IU/kg. ACT and aXa levels (R2= 0.873) and aIIa levels (R2=0.881), respectively were also well correlated. Maximal plasma concentrations for aXa and aIIa ranged from 0.09 - 1.52 and 0.08 - 1.11 IU/mL, respectively. Doses of 75 or 100 IU aXa activity per kg body weight resulted in mean ACT values greater than 200 seconds (215, 238 respectively). Mean elimination half-life was approximately 1 hour (range 0.83-1.27h) for both aXa and aIIa activity, and the ratio of aXa to aIIa activity was relatively constant over time.
About M118
M118 is a novel drug candidate that has been, through Momenta's proprietary technology, rationally engineered with attributes of monitorability, reversibility, flexible administration (intravenous and subcutaneous), and both potent and predictable anti-Xa (aXa) and anti-IIa (aIIa) activity 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. We believe an anticoagulant possessing these properties has the potential to satisfy a currently unmet medical need within the ACS patient population.
About Acute Coronary Syndromes
ACS is a classification of diagnoses used to describe patients experiencing an acute myocardial infarction, or heart attack, as well as patients who present at hospitals with unstable angina (sudden or worsening chest pain thought to be caused by a transient blockage of a coronary artery, often a precursor to a heart attack). 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 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. 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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Forward Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the Company's M118 program, results of clinical trials, regulatory filings, technology, current and future development efforts and commercialization efforts, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "hope," "target," "project," "goals," "potential," "predict," "might," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to in the Company's Annual Report on Form 10-K for the year ended December 31, 2007 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. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Momenta is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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