Dyslipidemia is a disorder characterized by abnormal levels of cholesterol in the blood.
When levels of low-density lipoprotein cholesterol (LDL-C) are elevated, patients carry an increased risk of developing atherosclerosis and cardiovascular disease. However, approximately 40% of patients with high cholesterol fail to meet their lipid-lowering goals with existing treatments. This population includes patients that are unable to tolerate the current standard of care, statins, due to muscle pain or liver toxicity, or are unable to achieve ideal lipid levels even when treated with the maximum dose of statins. Additionally, patients with genetic dyslipidemia disorders, such as familial hypercholesterolemia, which is characterized by high levels of LDL-C, also struggle with finding effective lipid-lowering treatments. Patients with heart disease and a history of myocardial infarction (MI) are at particularly high risk for another MI; these patients often fail to achieve their lipid-lowering goals with statins alone. It is estimated that approximately 18 million high-risk or high-cholesterol patients in the United States would benefit from a novel approach to controlling cholesterol levels.
ALD306, a potent monoclonal antibody to the protein PCSK9, targeted for the treatment of cardiovascular dyslipidemias, is currently in preclinical development at Alder.