The Phase II study is designed to treat patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). The company has also announced top-line results from a Phase I study in healthy volunteers designed to evaluate the human safety and pharmacokinetics of the intravenously administered anticoagulant, M118.
The primary objective of the Phase II trial is to evaluate the safety and feasibility of utilizing M118 as an anticoagulant during PCI. The multi-center study is expected to enroll approximately 600 patients with documented stable CAD who are planning to undergo a PCI.
Robert Harrington, professor of medicine at Duke University and director of the Duke clinical research institute, stated: “We’re very interested in M118’s potential. The data to date, both preclinical and Phase I, suggest that M118 may be able to improve upon current anticoagulant therapy in patients with acute coronary syndromes.”