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CHICAGO – A groundbreaking experimental drug developed by Eli Lilly has demonstrated a significant reduction in lipoprotein(a) (Lp(a)), a genetically inherited risk factor for heart disease, according to data presented at the American College of Cardiology meeting on Sunday.
The midstage trial revealed that lepodisiran, administered in one or two 400 milligram doses, reduced Lp(a) levels by an impressive average of 93.9% compared to a placebo over a six-month period. The study involved 141 patients in the combined 400 mg arm, while 69 received a placebo. Notably, no serious adverse events related to the drug were reported.
“What we have is a drug that can lower lipoprotein(a) with very infrequent administration,” stated Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and the study’s author, in an interview. The results were also published in the New England Journal of Medicine.
Lp(a) is a significant risk factor for heart disease, affecting an estimated 1.4 billion people worldwide, including 64 million in the United States. Unlike LDL cholesterol, which can be managed through diet and statins, there are currently no approved treatments for elevated Lp(a). This genetic condition can substantially increase the risk of heart attacks, strokes, aortic valve narrowing, and peripheral artery disease, with individuals of African ancestry at the highest risk.
Lilly has already advanced lepodisiran into late-stage clinical trials. However, Dr. Nissen emphasized the need for large-scale trials to confirm that lowering Lp(a) levels translates to a reduction in actual cardiovascular events. “While the drug reduced a cardiovascular risk factor, large trials are needed to prove that lowering Lp(a) actually cuts heart attacks and other adverse cardiovascular events,” he said.
Lilly is currently conducting a second Phase 3 trial to assess the drug’s effectiveness in reducing these risks, with patient enrollment expected to be completed this year.
Lilly’s lepodisiran is among several injectable treatments being developed to target Lp(a). Other companies, including Silence Therapeutics, Amgen, and Novartis, are also working on similar therapies. Additionally, Lilly is testing muvalaplin, the only oral treatment for Lp(a) currently in clinical trials. Merck has also recently entered the field, licensing an experimental Lp(a) pill from Jiangsu Hengrui Pharmaceuticals.
Disclaimer: This news article is based on preliminary clinical trial data. While the results are promising, further research and large-scale clinical trials are necessary to confirm the safety and efficacy of lepodisiran and other experimental Lp(a) treatments. The information provided should not be interpreted as medical advice. Individuals with concerns about their heart health or Lp(a) levels should consult with a qualified healthcare professional.
