By Julie Steenhuysen
CHICAGO (Reuters) – In a recent midstage trial, the highest dose of a new drug developed by Eli Lilly showed promising results in reducing a genetically inherited risk factor for heart disease. The data, presented at a major medical conference on Sunday, revealed that the experimental drug, lepodisiran, led to a substantial decrease in lipoprotein(a) levels.
During the trial, participants who received a single 400-milligram dose of lepodisiran experienced an average reduction of 93.9% in lipoprotein(a) levels compared to those who received a placebo over a six-month period. The study included 72 patients in the 400 mg group and 69 in the placebo group. After a second 400 mg dose at six months, participants observed an average reduction of nearly 95% over the course of 12 months. No serious adverse events linked to the drug were reported.
Dr. Steven Nissen, a respected cardiologist at the Cleveland Clinic and the study author, highlighted the drug’s potential in lowering lipoprotein(a) with minimal dosing frequency. Nissen shared these findings at the American College of Cardiology meeting in Chicago and they were also published in the New England Journal of Medicine.
Lilly’s drug is among the several undergoing testing to address high Lp(a), a common risk factor for heart disease affecting millions globally. Unlike LDL cholesterol, which can be managed with diet and statins, there are currently no approved treatments specifically targeting Lp(a), and many individuals may not even be aware of their elevated levels. High Lp(a) can significantly elevate the risk of heart attacks, strokes, aortic valve narrowing, and peripheral artery disease.
Individuals of African descent are at a heightened risk of high Lp(a). Lilly has progressed lepodisiran into advanced clinical trials, aiming to further validate its effectiveness in reducing cardiovascular risks.
Although the drug has shown promise in lowering a key cardiovascular risk factor, comprehensive trials are necessary to confirm that reducing Lp(a) directly correlates with a decrease in heart attacks and other cardiovascular events, Nissen emphasized. Lilly is currently conducting a second Phase 3 trial to explore the impact of lowering Lp(a) on these risks, with an anticipated completion of patient enrollment this year.
Other injectable treatments for Lp(a) currently in development include zerlasiran from Silence Therapeutics, olpasiran from Amgen, and pelacarsen from Novartis. Additionally, Lilly is also investigating muvalaplin, the sole oral treatment for Lp(a) in clinical trials. Merck recently entered a licensing agreement with Jiangsu Hengrui Pharmaceuticals to test their experimental Lp(a) pill, HRS-5346.
(Reporting by Julie Steenhuysen; Editing by Bill Berkrot)
