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Lerodalcibep (also known as LIB003) is an investigational drug being developed by LIB Therapeutics as a new treatment for high cholesterol. It is a third-generation proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor designed to reduce low-density lipoprotein cholesterol (LDL-C), often referred to as "bad cholesterol."
Lerodalcibep is a small recombinant fusion protein known as an "adnectin". It works by binding to the PCSK9 protein in the bloodstream. PCSK9's natural function is to destroy LDL receptors on the liver, which prevents the liver from clearing LDL-C from the blood. By inhibiting PCSK9, lerodalcibep prevents the degradation of these receptors, allowing them to remain active and more effectively remove LDL-C from circulation.
The drug is designed to be a convenient, once-monthly subcutaneous injection (under the skin). A key feature is its long-ambient stability, meaning it doesn't require refrigeration, which can improve patient adherence to long-term therapy.
Lerodalcibep has been studied in a comprehensive Phase 3 clinical program called the "LIBerate" program, which included over 2,900 patients with a range of conditions, including: [1]
The drug has consistently demonstrated the ability to achieve significant and sustained LDL-C reductions across its clinical trials. In addition to lowering LDL-C, it has also been shown to reduce other key lipid markers such as apolipoprotein B (ApoB) and lipoprotein(a) [Lp(a)].
In clinical trials, lerodalcibep has been generally well-tolerated. The most common adverse event reported has been mild to moderate injection site reactions, such as redness, itching, or bruising. Overall, the safety profile has been similar to that of a placebo.
LIB Therapeutics has submitted a Biologics License Application (BLA) for lerodalcibep to the U.S. Food and Drug Administration (FDA) for the treatment of elevated LDL-C in patients with ASCVD or primary hyperlipidemia, including those with HeFH and HoFH. The FDA has accepted the application and set a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2025. The company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).
If approved, lerodalcibep would offer a new, convenient, once-monthly treatment option for patients who are unable to reach their cholesterol goals with standard oral therapies.