Despite several recent therapeutic advances, cardiovascular disease remains the leading cause of morbidity and mortality in industrialized nations. Atherosclerosis affects 25% of Americans and accounts for nearly half of all deaths in developed countries. Although LDL-lowering therapeutic agents, such as statins, reduce the risk of cardiovascular disease, a significant residual risks remains.  Modulation of HDL composition and levels represents a new and complementary strategy for combating cardiovascular disease. However, epidemiological data indicate that HDL subclasses differ in their atheroprotective properties and that some subclasses may actually have pro-atherosclerotic effects.  This highlights the need to identify therapeutic agents that selectively induce the formation of specific HDL subclasses.

Dr. Godfrey Getz of The University of Chicago, a recognized leader in the field of atherosclerosis research, has engineered a novel set of human ApoA-I biologics that fulfills this unmet need.  These ApoA-I engineered proteins preferentially associate with specific HDL subclasses and represent a novel class of ApoA-I therapeutic agents that potentially have much better anti-atherosclerotic effects than the ApoA-I based therapies that are currently being developed, such as ApoA-I_Milano. Furthermore, these modified proteins form complexes with lipids that are more stable than those formed by human ApoA-I indicating that they may have additional atheroprotective properties.  This technology can also be easily adapted to delivery systems currently under development for ApoA-I and ApoA-I_Milano therapies. Since no current treatment options can reverse atherosclerotic vascular damage, this novel class of ApoA-I therapeutic agents represents a new weapon against atherosclerosis and has the potential to revolutionize the way in which cardiovascular disease is treated.

File Number: 1676