On Monday, Eli Lilly And Co LLY announced Phase 2 results for muvalaplin, an investigational once-daily, orally administered selective inhibitor of lipoprotein(a) [Lp(a)], a genetically inherited risk factor for heart disease.
In the U.S., about 20% of people, or approximately 63 million individuals, have high levels of Lp(a).
Elevated Lp(a) levels can double or even triple the risk of a heart attack and are associated with other cardiovascular issues.
The study demonstrated that muvalaplin significantly reduced elevated Lp(a) levels in adults, meeting its primary endpoint.
At the 12-week primary endpoint, muvalaplin (10 mg, 60 mg, and 240 mg) significantly reduced Lp(a) levels compared to placebo.
The placebo-adjusted reductions were up to 85.8% using an intact Lp(a) assay and up to 70.0% using an apo(a) assay.
- Specifically, the reductions were 47.6% (10 mg), 81.7% (60 mg) and 85.8% (240 mg) with the intact Lp(a) assay, and 40.4% (10 mg), 70.0% (60 mg) and 68.9% (240 mg) with the apo(a) assay.
Muvalaplin also met secondary endpoints for all three tested doses (10 mg, 60 mg, and 240 mg).
- The three tested doses achieved statistical significance for Lp(a) thresholds, and the 60 mg and 240 mg doses also achieved statistical significance for apoB reductions.
These data also demonstrated:
- Using the intact Lp(a) assay, the percentage of participants achieving normal Lp(a) levels of less than 125 nmol/L at week 12 was 64.2% (10 mg), 95.9% (60 mg), and 96.7% (240 mg), compared to 6.0% in the placebo group.
- Using the apo(a) assay, 38.9% (10 mg), 81.9% (60 mg), and 77.4% (240 mg) of participants achieved an Lp (a) level of less than 125 nmol/L, compared to 3.6% in the placebo group.
- ApoB levels were reduced at all doses, with placebo-adjusted reductions of 8.9% (10 mg), 13.1% (60 mg) and 16.1% (240 mg).
Adverse events were similar in both the muvalaplin and placebo groups.
Price Action: LLY stock is down 0.44% at $723.97 at the last check on Tuesday.
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