Myriad Genetics announced today that it is rapidly nearing completion of the preclinical data package on MPC-0920, its antithrombin drug candidate, for submission to the FDA prior to beginning human clinical trials.
MPC-0920 is an orally available, direct thrombin inhibitor. It is designed to address the clinical needs for rapid and predictable anticoagulant action, an improved therapeutic window, predictable patient response and increased efficacy. MPC-0920 has been the subject of 27 preclinical GLP studies to date, comprising safety, toxicity, pharmacokinetics and formulation. MPC-0920 is covered by four issued patents -- two in the U.S. and two foreign.
"MPC-0920 is an intriguing compound in a vitally important therapeutic area," said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "We look forward to completing the preclinical data package for submission to the FDA this fiscal year."
Thrombosis, the formation of a clot within a blood vessel, is the most common cause of death in the United States. Approximately two million individuals in the United States die each year from an arterial or venous thrombosis or its consequences. In addition, thrombosis results in significant morbidity particularly in the elderly. The most common form of thrombosis is deep-vein thrombosis (DVT) in the leg. This type of clot can break apart, travel up the leg and through the heart, lodging in the lungs and causing blockage of an artery. Known as pulmonary embolism, this condition causes lung tissue death and is an often-fatal complication of DVT.
The drugs currently used to treat this condition are the anticoagulants heparin and warfarin. They are widely used, one-third of hospitalized patients in the United States, approximately 12 million in total, receive heparin. However, both drugs have major drawbacks. Heparin requires intravenous administration and blood-level monitoring. Heparin-induced thrombocytopenia, low platelet count, is the most common serious drug reaction in hospitals. Warfarin is the only orally-available anti-thrombotic currently approved for use in the US. It has a very small therapeutic window and serious drug interaction problems and is very hard to use clinically. Accordingly, there is a large and urgent unmet medical need for new therapies.
The total market for medicines to treat thrombotic disorders in 2003 was $6.5 billion.