Yesterday, Eli Lilly and Company revealed promising Phase 2 results for its investigational small molecule drug, Muvalaplin, against cardiovascular events. The drug met its primary and secondary endpoints at 12 weeks, revealing a reduction of lipoprotein(a)– Lp(a)– levels by up to 85% in adults with high risk for cardiovascular events.
Muvalaplin selectively inhibits Lp(a), a genetic risk factor for heart disease. In the U.S., about 63 million people are known to have high levels of Lp(a). Lp(a) can form plaques in the walls of blood vessels, disrupting blood flow to essential organs, including the heart, kidneys, lungs, and brain. An excessive accumulation of Lp(a) plaques can result in heart attack, stroke, or other cardiovascular diseases.
Eli Lilly’s Muvalaplin blocks the interaction between apolipoprotein(a) and apolipoprotein B, preventing the formation of Lp(a), and thereby lowering the risk of cardiovascular diseases.
“High levels of Lp(a) have been shown to be a significant risk factor for atherosclerotic cardiovascular disease, affecting over one billion adults globally,” explained Stephen J. Nicholls, Director of the Victorian Heart Hospital and Institute, and Professor of Cardiology at Monash University, Australia, in a press release.
“Current cholesterol-lowering therapies are not approved to lower Lp(a) levels, highlighting an unmet need for people living with cardiovascular disease. These data represent a needed scientific advancement with the potential to reduce the risk of cardiovascular events such as heart attacks or strokes with a once-daily pill.”
In the Phase 2 study, Muvalaplin was given to participants in three different dosages– 10mg, 60mg, and 240mg– and tested against a placebo. At all dosages, Muvalaplin showed a reduction of Lp(a) levels compared to the placebo. The researchers measured the reductions using an Lp(a) assay– up to 85.8% Lp(a) reduction– and an apolipoprotein(a) assay– up to 70% Lp(a) reduction– at the highest dosage.
“While injectable approaches for Lp(a) are currently in Phase 3 development, including Lilly’s own lepodisiran program, these are the first positive Phase 2 data for an oral approach,” said Ruth Gimeno, Group Vice President of Diabetes and Metabolic Research at Lilly Research Laboratories, in a press release. “We are very pleased to see these promising results and look forward to further exploring next steps for Muvalaplin.”
Cardiovascular disease treatments have seen a major surge in interest from big pharma companies. Just recently, AstraZeneca entered into a licensing deal worth up to $2 billion with the Chinese company CSPC Pharmaceutical Group to further develop its oral small molecule drug targeting Lp(a)– a rival to Lilly’s Muvalaplin.
