LIB Therapeutics, Inc. (LIB), a pioneering biopharmaceutical company, has made considerable progress with its cholesterol-lowering drug, Lerodalcibep and designed as a potent PCSK9 inhibitor, Lerodalcibep targets cardiovascular disease (CVD) treatment and prevention. Hasten Biopharmaceuticals Co, Ltd., LIB’s regional partner in China, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China to proceed with clinical trials for Lerodalcibep.
This development follows an agreement established in September 2023 between LIB and Hasten, granting Hasten the rights to develop and commercialize Lerodalcibep across Greater China. This strategic partnership aims to address the needs of a vast Chinese population requiring substantial LDL-C reductions, even when on statin therapy. The NMPA’s acceptance of the clinical trial application paves the way for Hasten to initiate bridging studies essential for the drug’s approval in China.
Lerodalcibep distinguishes itself not only through its efficacy but also its user-friendly administration. It is a once-monthly, small-volume, subcutaneous injection that can be stored without refrigeration, making it an attractive option for patients. Its comprehensive development has involved substantial clinical trials in the U.S., Europe, and globally, demonstrating sustained LDL-C reductions.
LIB is concurrently preparing its own applications for regulatory approvals in the United States and Europe, targeting a broad patient demographic that includes those at high risk for atherosclerotic cardiovascular disease (ASCVD) and patients with familial hypercholesterolemia (FH).
Lerodalcibep represents a significant advancement in treatment options for millions globally, embodying potential best-in-class efficacy for lowering LDL-C for patients with ASCVD and familial hypercholesterolemia. With over 2,700 patients enrolled in its global Phase 3 LIBerate program, Lerodalcibep is steadily moving towards commercial availability, promising to transform the landscape of cardiovascular disease treatment.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
