Lilly's muvalaplin lowered lipoprotein(a) levels in adults with high risk for cardiovascular events by up to 85% at highest tested dose
Rhea-AI Summary
Eli Lilly announced positive Phase 2 results for muvalaplin, an oral once-daily treatment that significantly reduced lipoprotein(a) [Lp(a)] levels in adults at high risk for cardiovascular events. The study met its primary endpoint, showing placebo-adjusted reductions up to 85.8% using an intact Lp(a) assay and up to 70.0% using an apo(a) assay at week 12. The drug was tested at three doses (10mg, 60mg, 240mg), with all doses achieving statistical significance for Lp(a) thresholds. Adverse events were similar between muvalaplin and placebo groups, with treatment-related events occurring in 5.9-14.7% of treatment groups.
Positive
- Achieved significant Lp(a) reduction up to 85.8% in Phase 2 trial
- Met both primary and secondary endpoints across all tested doses
- Demonstrated favorable safety profile with adverse events similar to placebo
- Offers potential first-in-class oral treatment option for elevated Lp(a)
- Showed significant apoB level reductions up to 16.1%
Negative
- Higher discontinuation rates (up to 8.8%) in some treatment groups
News Market Reaction – LLY
In the trading session that priced this news, LLY declined 2.55%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Muvalaplin, an oral, once-daily treatment that inhibits lipoprotein(a) formation via a novel mechanism, achieved positive results in a 12-week Phase 2 study
These data were published in the Journal of the American Medical Association (JAMA) and simultaneously presented today at the American Heart Association (AHA) Scientific Sessions 2024
At the 12-week primary endpoint, muvalaplin (10 mg, 60 mg and 240 mg) showed significant reductions in Lp(a) levels compared to placebo. The placebo-adjusted reductions were up to
"High levels of Lp(a) have been shown to be a significant risk factor for atherosclerotic cardiovascular disease, affecting over one billion adults globally," said Stephen J. Nicholls, MBBS, Ph.D., director of the Victorian Heart Hospital and Institute, and professor of cardiology at Monash University,
Lilly is evaluating muvalaplin, a potent, multivalent, small molecule that inhibits the formation of Lp(a) by blocking the initial interaction between apolipoprotein(a) [apo(a)] and apolipoproteinB (apoB). In the
"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, Ph.D., group vice president, Diabetes and Metabolic Research, Lilly Research Laboratories. "We are very pleased to see these promising results and look forward to further exploring next steps for muvalaplin."
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 an Lp(a) level less than 125 nmol/L at week 12 was
64.2% (10 mg),95.9% (60 mg) and96.7% (240 mg), compared to6.0% in the placebo group. - Using the apo(a) assay, the percentage of participants achieving an Lp(a) level less than 125 nmol/L was
38.9% (10 mg),81.9% (60 mg) and77.4% (240 mg), compared to3.6% in the placebo group. - ApoB levels were reduced at all doses, with placebo-adjusted reductions of
8.9% (10 mg),13.1% (60 mg) and16.1% (240 mg).
Adverse events were similar in both the muvalaplin and placebo groups. Treatment-emergent adverse events related to the study drug occurred in
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about muvalaplin as a potential treatment for people with high risk for cardiovascular events and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that muvalaplin will prove to be a safe and effective treatment for the reduction of cardiovascular events associated with a reduction in Lp(a), that muvalaplin will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
References
1. Family Heart Foundation. Lipoprotein(a) - Family Heart Foundation. Last accessed Nov. 13, 2024.
2. Family Heart Foundation. Diagnosing High Lipoprotein(a) - Family Heart Foundation. Last accessed Nov. 13, 2024.
3. Harvard Medical School. Heart Health: The Latest on Lipoprotein(a), an Inherited Cause of Early Heart Disease. Last accessed Nov. 13, 2024.
Refer to: Stefanie Prodouz; stefanie.prodouz@lilly.com; 317-287-9899 (Media)
Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)
View original content to download multimedia:https://www.prnewswire.com/news-releases/lillys-muvalaplin-lowered-lipoproteina-levels-in-adults-with-high-risk-for-cardiovascular-events-by-up-to-85-at-highest-tested-dose-302308807.html
SOURCE Eli Lilly and Company