Myriad Genetics begins phase 1 trial of anti-thrombin drug MPC-0920

By E. Janene Geiss

Philadelphia, May 2 - Myriad Genetics, Inc. has begun a phase 1 human clinical trial of MPC-0920, an orally available, direct thrombin inhibitor.

The trial will enroll healthy volunteers in a single, escalating dose format, according to a company news release.

The study is designed to determine the safety, dose range and pharmacokinetics of the drug candidate, officials said.

The market to treat thrombosis is large, totaling more than $6.5 billion in the United States last year, and there is an urgent need for improved drugs, particularly those that can be taken orally, officials said.

The company said MPC-0920 is designed to address these medical needs for rapid and predictable anticoagulant action, an improved therapeutic window, predictable patient response and increased efficacy.

The phase 1 trial will be administered in a single ascending-dose format with eight volunteers per cohort, six of whom are given the drug and two of whom are given a placebo.

The dose escalation will continue until a blood clotting time that is several times higher than normal and sufficient to ensure clinical utility in thrombotic conditions is reached, officials said.

The primary objective is to examine the safety of MPC-0920 and a secondary objective will be to study the biological activity of MPC-0920.

Because MPC-0920 demonstrated an effect on blood clotting time in animal studies, even at very low dose, the company said it expects the phase 1 trial to show it to have an effect at a low dose in humans as well.

The company said this could allow it to determine a biological effect in the volunteers, which is unlike the situation in most phase 1 studies.

MPC-0920 has been the subject of 27 preclinical studies to date, comprising safety, toxicity, pharmacokinetics and formulation. MPC-0920 is covered by two U.S. patents and two foreign patents.

Thrombosis, the formation of a clot within a blood vessel, is one of the most common causes of death in the Western World. About 2 million people in the United States die each year from an arterial or venous thrombosis or its consequences.

Myriad is a Salt Lake City biopharmaceutical company focused on the development of novel health care products.

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