Eli Lilly reports positive Phase 2 results for Muvalaplin in heart disease

Just yesterday, Eli Lilly and Company announced encouraging Phase 2 results for Muvalaplin, an experimental small molecule drug aimed at reducing cardiovascular events. Muvalaplin achieved its primary and secondary goals at the 12-week mark, showing up to an 85% decrease in lipoprotein(a)– Lp(a)– levels in adults at high risk for cardiovascular incidents.

Muvalaplin functions by selectively inhibiting Lp(a), a genetic factor tied to heart disease. In the United States, approximately 63 million people have elevated Lp(a) levels, which can lead to plaque formation in blood vessels, eventually disrupting blood flow to vital organs such as the heart, kidneys, lungs, and brain. Excessive Lp(a) plaque buildup can trigger heart attacks, strokes, or other cardiovascular issues.

The drug works by blocking the interaction between two proteins, apolipoprotein(a) and apolipoprotein B, thereby preventing the formation of Lp(a) and reducing the risk of cardiovascular diseases. Stephen J. Nicholls, Director of the Victorian Heart Hospital and Institute and Professor of Cardiology at Monash University in Australia, noted the significance of high Lp(a) levels as a risk factor for atherosclerotic cardiovascular disease, which affects over a billion adults globally.

Nicholls pointed out that existing cholesterol-lowering treatments are not approved for reducing Lp(a) levels, highlighting an important unmet need for those with cardiovascular disease. He emphasized that the data represents a critical scientific breakthrough, with the potential to lower the risk of cardiovascular events like heart attacks or strokes through a once-daily oral medication.

In the Phase 2 trial, participants were given Muvalaplin in three different doses– 10mg, 60mg, and 240mg– compared to a placebo. Across all doses, Muvalaplin significantly reduced Lp(a) levels. The researchers used two types of assays to measure the reductions: one specific to Lp(a), showing up to an 85.8% reduction, and another for apolipoprotein(a), showing up to a 70% reduction at the highest dose.

Ruth Gimeno, Group Vice President of Diabetes and Metabolic Research at Lilly Research Laboratories, expressed satisfaction with the results, noting that while injectable treatments for Lp(a) are in Phase 3 development, including Lilly’s own lepodisiran program, these findings are the first positive Phase 2 data for an oral treatment. Gimeno indicated that the company looks forward to further investigating the potential of Muvalaplin.

The field of cardiovascular disease treatment has garnered significant interest from major pharmaceutical companies. Recently, AstraZeneca entered into a licensing agreement worth up to $2 billion with the Chinese firm CSPC Pharmaceutical Group to advance its own oral small molecule drug targeting Lp(a), a competitor to Lilly’s Muvalaplin.