On November 16, at the American Heart Association (AHA) 2024 Annual Scientific Sessions in Chicago, IL, US, clinical trial results were presented from the ongoing open-label extension trial, LIBERATE-OLE. This trial involved 703 patients with heterozygous familial hypercholesterolemia (HeFH), identified from five Phase III studies, who were evaluated for the long-term efficacy and safety of LIB Therapeutics’ lerodalcibep in achieving additional low-density lipoprotein cholesterol (LDL)-C reduction.
Lerodalcibep is a third-generation proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor developed to treat hypercholesterolemia, particularly for patients with complex conditions like HeFH and those who fail to achieve adequate cholesterol reduction with statins alone. Like monoclonal antibodies, lerodalcibep binds to PCSK9, blocking its interaction with LDL receptors (LDLR). This prevents LDLR degradation, promotes LDLR recycling, enhances LDL-C clearance, and reduces LDL-C levels. As a result, lerodalcibep effectively targets a critical pathway in cholesterol regulation.
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Professor Federick Raal, FRCP, FRCPC, M Med, MBBCh, PhD Director of the Carbohydrate and Lipid Metabolism Research Unit, reported the results of the LIBRATE-OLE trial. This cohort expanded from an initial group of 478 participants in the earlier LIBerate-HeFH study, with 421 continuing into the open-label extension phase. Patients in this study, who were already on lipid-lowering therapies such as statins and ezetimibe, received a 300mg dose of lerodalcibep once per month. Lerodalcibep demonstrated impressive efficacy, with over 80% of familial hypercholesterolemia (FH) patients achieving more than a 50% reduction in LDL-C and approximately 70% reaching recommended LDL-C targets for individuals with atherosclerotic cardiovascular disease (ASCVD) or high ASCVD risk during the 72-week period. Additionally, lerodalcibep reduced apolipoprotein B (ApoB) levels by 36% and median lipoprotein(a) Lp(a) levels by 25%. The treatment was well tolerated over 72 weeks, with only 2.3% of doses associated with mild or moderate injection site reactions (ISRs) and no new safety concerns reported. These results support the long-term use of monthly lerodalcibep for managing HeFH patients who are unable to reach LDL-C targets with standard oral lipid-lowering therapies.
Lerodalcibep, like established PCSK9 inhibitors such as Regeneron’s Praluent (alirocumab) and Amgen’s Repatha (evolocumab), targets the PCSK9 protein to help reduce LDL-C levels. However, it distinguishes itself with its unique design as a long-acting bispecific monoclonal antibody, which may provide an added advantage over existing treatments for dyslipidemia. Lerodalcibep offers the convenience of a once-monthly injection, reducing the dosing frequency compared to many other PCSK9 inhibitors. Key opinion leaders (KOLs) interviewed by GlobalData have noted that patients often prefer a once-monthly injection over daily pills, as it is more convenient and reduces the burden of daily medication, potentially improving adherence for life-long therapy needed in HeFH. The current study reinforces the findings from the previous LIBerate trials, which confirmed lerodalcibep’s significant LDL-C-lowering effects. These promising results suggest that lerodalcibep may be a valuable addition to the therapeutic options for patients with HeFH.
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