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
INDIANAPOLIS, Nov. 18,
2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) today announced positive 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. The study demonstrated that muvalaplin significantly
reduced elevated Lp(a) levels in adults, meeting its primary
endpoint of percent change in Lp(a) from baseline to week 12.
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 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.
"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, Australia. "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."
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 U.S., about 20% of people, or
approximately 63 million individuals, have high levels of
Lp(a).1,2 Elevated Lp(a) levels can double or even
triple the risk of a heart attack and are associated with other
cardiovascular issues.3
"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) and 96.7% (240 mg), compared to 6.0% 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) and 77.4% (240 mg), 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. Treatment-emergent adverse events related to the study drug
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. The
incidence of adverse events leading to discontinuation of study
drug varied from 0 to 8.8% across treatment groups and were single
events spread across system organ classes. No deaths were reported
in the study.
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)
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