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LLY Oral Cholesterol Drug Lowers Lipoprotein Levels in Phase II Study

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Eli Lilly (LLY - Free Report) announced that its investigational oral, once-daily cholesterol-lowering drug muvalaplin reduced lipoprotein(a) or Lp(a) levels in adults with high risk of cardiovascular events in a 12-week phase II study.

In the study, muvalaplin led to a significant reduction in elevated Lp(a) levels compared to placebo, meeting the study’s primary endpoint of percent change in Lp(a) from baseline to week 12.  Using an intact Lp(a) assay, the reductions in Lp(a) levels were 47.6% for the 10 mg dose, 81.7% for the 60 mg dose and 85.8% for the 240 mg dose. With an apo(a) assay, the reductions were 40.4% (10 mg), 70.0% (60 mg) and 68.9% (240 mg). Muvalaplin also met secondary endpoints for all three doses. Treatment-related adverse events occurred in 14.9% of the placebo group, 5.9% of the 10 mg group, 14.3% of the 60 mg group and 14.7% of the 240 mg group.

Lilly’s stock has risen 24.7% so far this year compared with an increase of 3.4% for the industry.

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How Does LLY’s Muvalaplin Work?

Elevated Lp(a) levels are strongly associated with coronary disease. High levels of lipoprotein in your blood can block arteries by sticking up to their walls, leading to heart disease and stroke. However, currently available cholesterol-lowering medicines are not approved to lower Lp(a) levels in people living with cardiovascular disease. This creates a significant unmet need for once-daily pills like muvalaplin, which has shown the potential to reduce the risk of heart attacks or strokes. Muvalaplin has a novel mechanism of action. It disrupts the interaction between apolipoprotein(a) and apolipoprotein(b, which prevents the formation of Lp(a). Apolipoprotein(a) is a key component of Lp(a), which increases the risk of cardiovascular events. 

Other Companies Making Lp(a)-Lowering Drugs

Some injectable treatments for lowering Lp(a) are in phase III studies including Lilly’s own RNA-based candidate, lepodisiran. Other RNA based phase III injectable candidates being developed to lower levels of Lp(a) are Novartis’ (NVS - Free Report) pelacarsen, which it is developing in partnership with Ionis Pharmaceuticals (IONS - Free Report) and Amgen’s (AMGN - Free Report) olpasiran. NVS and IONS plan to release data from the phase III study on pelacarsen next year. Data from a phase II study on Amgen’s olpasiran showed that the candidate reduced Lp(a)levels by more than 95% in patients with established atherosclerotic cardiovascular disease.

LLY’s Zacks Rank

Eli Lilly has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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