Lilly's muvalaplin lowered lipoprotein(a) levels in adults with high risk for cardiovascular events by up to 85% at highest tested dose
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.
Eli Lilly ha annunciato risultati positivi della Fase 2 per muvalaplin, un trattamento orale da assumere una volta al giorno che ha ridotto significativamente i livelli di lipoproteina(a) [Lp(a)] negli adulti ad alto rischio di eventi cardiovascolari. Lo studio ha raggiunto il suo obiettivo primario, mostrando riduzioni rispetto al placebo fino al 85.8% utilizzando un'assay di Lp(a) intatta e fino al 70.0% utilizzando un'assay di apo(a) alla settimana 12. Il farmaco è stato testato in tre dosi (10mg, 60mg, 240mg), con tutte le dosi che hanno raggiunto significatività statistica per le soglie di Lp(a). Gli eventi avversi sono stati simili tra i gruppi di muvalaplin e placebo, con eventi correlati al trattamento che si sono verificati nel 5.9-14.7% dei gruppi di trattamento.
Eli Lilly anunció resultados positivos de la Fase 2 para muvalaplin, un tratamiento oral que se toma una vez al día y que redujo significativamente los niveles de lipoproteína(a) [Lp(a)] en adultos con alto riesgo de eventos cardiovasculares. El estudio cumplió su objetivo principal, mostrando reducciones ajustadas al placebo de hasta 85.8% utilizando un ensayo de Lp(a) intacta y de hasta 70.0% utilizando un ensayo de apo(a) a la semana 12. El fármaco fue probado en tres dosis (10mg, 60mg, 240mg), con todas las dosis alcanzando significación estadística para los umbrales de Lp(a). Los eventos adversos fueron similares entre los grupos de muvalaplin y placebo, con eventos relacionados con el tratamiento ocurriendo en el 5.9-14.7% de los grupos de tratamiento.
엘리 릴리는 심혈관 사건의 높은 위험에 처한 성인에서 Lp(a) 수치를 크게 감소시킨 하루 한 번 경구 치료제인 무발라플린에 대한 긍정적인 2상 임상 결과를 발표했습니다. 이 연구는 주요 목표를 충족했으며, 12주차에 Lp(a) 전량 검사를 사용하여 위약 조정 감소가 최대 85.8%에 달하고, apo(a) 검사 사용 시 최대 70.0%에 도달했습니다. 이 약물은 세 가지 용량(10mg, 60mg, 240mg)에서 테스트되었으며, 모든 용량에서 Lp(a) 기준에 대한 통계적 유의성이 달성되었습니다. 부작용은 무발라플린 그룹과 위약 그룹 간에 비슷했으며, 치료와 관련된 부작용은 치료 그룹의 5.9-14.7%에서 발생했습니다.
Eli Lilly a annoncé des résultats positifs de la Phase 2 pour muvalaplin, un traitement oral à prendre une fois par jour, qui a considérablement réduit les niveaux de lipoprotéine(a) [Lp(a)] chez des adultes à haut risque d'événements cardiovasculaires. L'étude a atteint son objectif principal, montrant des réductions ajustées par rapport au placebo allant jusqu'à 85.8% avec un test Lp(a) intact et jusqu'à 70.0% avec un test apo(a) à la semaine 12. Le médicament a été testé à trois doses (10 mg, 60 mg, 240 mg), toutes atteignant une signification statistique pour les seuils de Lp(a). Les événements indésirables étaient similaires entre les groupes de muvalaplin et de placebo, avec des événements liés au traitement survenant dans 5.9-14.7% des groupes de traitement.
Eli Lilly hat positive Ergebnisse der Phase 2 für Muvalaplin bekannt gegeben, eine einmal täglich einzunehmende orale Behandlung, die die Lipoprotein(a) [Lp(a)]-Spiegel bei Erwachsenen mit hohem Risiko für kardiovaskuläre Ereignisse erheblich senkte. Die Studie erreichte ihren primären Endpunkt und zeigte platzebo-adjustierte Reduktionen von bis zu 85.8% mit einem intakten Lp(a)-Assay und bis zu 70.0% mit einem apo(a)-Assay in Woche 12. Das Medikament wurde in drei Dosen (10mg, 60mg, 240mg) getestet, wobei alle Dosen statistische Signifikanz für die Lp(a)-Grenzwerte erreichten. Nebenwirkungen waren zwischen den Muvalaplin- und Placebogruppen ähnlich, wobei behandlungsbezogene Ereignisse in 5.9-14.7% der Behandlungsgruppen auftraten.
- 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%
- Higher discontinuation rates (up to 8.8%) in some treatment groups
Insights
The Phase 2 trial results for muvalaplin represent a significant breakthrough in cardiovascular disease treatment. The drug achieved remarkable
Three key aspects make these results particularly noteworthy:
- Dose-dependent response showing efficacy even at lower doses
- Favorable safety profile with adverse events comparable to placebo
- High percentage of patients achieving target Lp(a) levels below 125 nmol/L
The market potential is substantial, with approximately 63 million Americans having elevated Lp(a) levels. This represents a significant commercial opportunity for Lilly, especially given the current lack of approved treatments specifically targeting Lp(a) reduction.
These results could significantly strengthen Lilly's cardiovascular portfolio and market position. The oral administration route provides a competitive advantage over injectable therapies, potentially leading to better patient compliance and market adoption. With no currently approved treatments for elevated Lp(a), muvalaplin could become a first-in-class oral therapy addressing this significant unmet need.
The global market opportunity is substantial, with over 1 billion adults affected worldwide. Given Lilly's strong commercialization capabilities and the drug's promising efficacy profile, this could translate into a multi-billion dollar revenue opportunity. The positive safety profile and once-daily dosing further enhance the commercial prospects.
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)
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SOURCE Eli Lilly and Company
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