LIB Therapeutics Reports Positive Phase 3 Lerodalcibep Results at European Atherosclerosis Congress

LIB Therapeutics Inc. (LIB), a private biopharmaceutical firm, has announced favorable outcomes from two key Phase 3 studies evaluating Lerodalcibep, a third-generation PCSK9 inhibitor aimed at lowering LDL cholesterol. These findings were shared at the 92nd European Atherosclerosis Society Congress held in Lyon, France, from May 26-29, 2024.

Phase 3 LIBerate-CVD Study

The global Phase 3 LIBerate-CVD study involved 922 patients and was a randomized, double-blind, placebo-controlled trial. The study aimed to assess the 52-week efficacy and safety of Lerodalcibep among patients with a history of cardiovascular disease (CVD) or at very high risk, already undergoing stable lipid-lowering therapy. Participants were randomly assigned in a 2:1 ratio to receive either a monthly 300 mg subcutaneous dose of Lerodalcibep or a placebo over 52 weeks. The study's primary focus was on the percentage change in LDL-C levels at Week 52 and the average over Weeks 50 and 52. Secondary outcomes included achieving European Atherosclerosis Society (EAS) and European Society of Cardiology (ESC) LDL-C targets, along with other lipid and apolipoprotein changes.

Key findings from the study revealed that Lerodalcibep achieved a significant and sustained reduction in LDL-C levels—62% at Week 52 and 69.4% at the mean of Weeks 50 and 52. Additionally, 94% of patients reached the stringent ESC and global lipid targets of a ≥50% reduction in LDL-C from baseline and LDL-C levels below 55 mg/dL. Lerodalcibep also led to marked reductions in non-HDL-C (50.5%), Apo B (45%), and Lp(a) (33%).

Lerodalcibep was generally well tolerated with adverse events similar to the placebo group, the most common being mild to moderate injection site reactions. There was no significant difference in discontinuation rates between the Lerodalcibep and placebo groups. Notably, Lerodalcibep was not associated with in vivo active ADA or NAbs, and there was no attenuation of its LDL-C efficacy.

Phase 3 LIBerate-VI (Lerodalcibep vs Inclisiran) Study

The LIBerate-VI study was an open-label, randomized trial comparing the efficacy and safety of Lerodalcibep versus Inclisiran in patients with very high risk for CVD, requiring additional LDL-C reduction. Conducted across 21 centers in Europe, the study included 166 patients randomized 1:1 to receive either Lerodalcibep 300 mg monthly or Inclisiran 284 mg on Day 1 and Day 90 over nine months.

Primary efficacy endpoints were the percentage change in LDL-C levels from baseline at Day 270. Secondary outcomes included achieving EAS/ESC LDL-C targets and other lipid and apolipoprotein changes. Results showed a mean LDL-C reduction of 53% for Lerodalcibep compared to 45.3% for Inclisiran in the mITT population. More patients on Lerodalcibep achieved the EAS/ESC targets compared to those on Inclisiran. Greater reductions in non-HDL-C, Apo B, and Lp(a) were also observed with Lerodalcibep.

Both treatments were well tolerated with similar adverse event rates. David Cory, CEO of LIB Therapeutics, highlighted Lerodalcibep's potential for robust and sustained LDL-C lowering in a convenient, once-monthly injection that is stable at room temperature.

About Lerodalcibep

Lerodalcibep is a novel small binding protein and third-generation PCSK9 inhibitor designed for monthly subcutaneous administration. It has shown sustained LDL-C reductions in clinical trials and offers a promising treatment for patients with atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia (FH).

The LIBerate program enrolled over 2,700 patients globally, and Lerodalcibep was administered for up to 52 weeks in these trials. LIB Therapeutics is preparing a biologics license application (BLA) for regulatory submission in 2024, aiming for approval from the FDA and the European Medicines Agency.

About LIB Therapeutics Inc.

LIB Therapeutics is focused on developing Lerodalcibep for patients with CVD and familial hypercholesterolemia, who need significant LDL-C reductions despite current treatments.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!