LIB Therapeutics Announces Completion of the Global Phase 3 LIBerate Program of Lerodalcibep, a Novel Third-Generation PCSK9 Inhibitor in Development for Cardiovascular Disease
LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company developing Lerodalcibep, a novel, third-generation PCSK9 inhibitor for patients at very high and high risk of cardiovascular disease (CVD), today announced completion of LIBerate-CVD and LIBerate-HR, the final two registration-enabling Phase 3 trials for patients with CVD or at very high and high risk of CVD.
- LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company developing Lerodalcibep, a novel, third-generation PCSK9 inhibitor for patients at very high and high risk of cardiovascular disease (CVD), today announced completion of LIBerate-CVD and LIBerate-HR, the final two registration-enabling Phase 3 trials for patients with CVD or at very high and high risk of CVD.
- These two trials are part of the registration-enabling Phase 3 LIBerate Program which includes four key studies of 2,387 patients dosed for up to 52 weeks, with >2,200 patients continuing in an open-label extension study of 72 weeks.
- “The global Phase 3 LIBerate program for Lerodalcibep is a large and comprehensive registration-enabling package and includes a diverse global population of patients with CVD, without CVD but at very high and high risk for CVD, and heterozygous and homozygous familial hypercholesterolemia (FH) which should support a broad label upon approval,” said David Kallend, MBBS, Chief Medical Officer of LIB Therapeutics.
- “We look forward to working with regulators to submit a biologics license application to the Food and Drug Administration and marketing authorization application to the European Medicines Agency in 1H 2024.”