LIB Therapeutics Announces Key Results from Presentations at 2025 European Atherosclerosis Society Meeting in Glasgow May 5-6

CINCINNATI–(BUSINESS WIRE)–LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep (LeroChol^®), a novel, monthly, small dose third-generation PCSK9 inhibitor today announced results presented at the May 5-7 2025 European Atherosclerosis Society meeting in Glasgow.

• LERODALCIBEP ADJUDICATED CARDIOVASCULAR EVENTS IN A PRE-DEFINED POOLED ANALYSIS OF THREE LARGE LONG TERM PHASE III STUDIES – Dr David Kallend May 5th
  • As part of the safety analysis, a prespecified exploratory endpoint of major adverse cardiovasular events (MACE) adjudicated by a blinded Clinical Events Committee of all serious CV adverse events.
  • A patient-level, pre-defined pooled analysis of the pivotal placebo-controlled Phase III studies (LIBerate-HR, LIBerate-CVD and LIBerate-HeFH), included patients on maximally tolerated statin with or without other oral lipid-lowering-therapy.
  • Patients were randomized 2:1 to 300mg lerodalcibep or placebo monthly SC for 24 (LIBerate-HeFH) or 52 weeks (LIBerate-HR and LIBerate-CVD).

*placebo adjusted mITT analysis; ^#MACE = composite of death, resuscitated cardiac arrest, acute myocardial infarction (STEMI and NSTEMI), hospitalization for unstable angina, stroke and coronary revascularization

• The early and large risk reductions in MACE of 45% to 50% provide encouraging insights into the potential CV benefits of lowering LDL-C with lerodalcibep and these findings await confirmation in a planned large definitive CV outcomes trial to start Q3 this year.
  
  

• PHASE 3 POOLED LONG-TERM SAFETY AND EFFICACY OF LERODALCIBEP IN PATIENTS WITH ASCVD, HEFH, VERY HIGH OR HIGH RISK FOR ASCVD – David Kallend May 6
  • Pooled safety and efficacy was assessed from the key three blinded placebo-controlled Phase 3 trials (LIBerate-CVD, LIBerate-HR and LIBerate-HeFH) in patients with atherosclerotic cardiovascular disease (ASCVD), very high or high risk for ASCVD on stable maximally tolerated statin therapy and additional oral agents.
  • The mean (SE) placebo-adjusted reductions in LDL-C at (Weeks 24 and 52 respectively) ‘trough’ with lerodalcibep were;
    • mITT analysis was, 58.6(1.3)% and 59.0(1.5)%,
    • ITT with imputation was 54.9(1.4)% and 52.3(1.7)%
    • Per-Protocol analysis was 61.8(1.4)% and 62.3(1.5)%
  • The placebo adjusted LDL-C reduction at ‘peak’ (2 week post dose) in the mITT population was 73.7% at Week 50 and the mean of weeks 50 and 52 was 66.0(1.3)%.
  • On lerodalcibep, 83% of subjects at Week 24 and 90% of subjects at Week 52 achieved both ESC/EAS recommended targets of >50 additional LDL-C reduction and their new lower targets.
  • Lerodalcibep was well tolerated with 90.3% and 88.7% of subjects completing the study at Weeks 24 and 52 respectively
  • Adverse events were similar between groups, other than more mild injection site reactions (ISRs) on lerodalcibep. The few and sporadic in-vitro anti-drug antibodies had no impact on efficacy or safety.

“We are very pleased and encouraged by the results from the pooled key registration trials, which were large, of long duration, and placebo-controlled,” said Dr. David Kallend, Chief Medical Officer of LIB Therapeutics. “The data demonstrates substantial and durable reductions in LDL-C – both in absolute terms and percentage change – as well as in other atherogenic lipoproteins such as Lp(a) and ApoB.”

He continued, “Lerodalcibep was well tolerated with no safety concerns or drug-drug interactions, especially important for patients with CVD already on multiple other oral therapeutic agents. Its patient-friendly profile, including the only monthly, 12 doses per year, single small-volume SC injection which along with long-term ambient stability not requiring refrigeration by patients, makes it especially well-suited for patients with CVD or at high-risk for CVD, including those with FH, to help them achieve the new, more aggressive LDL-C targets and maintain life long adherence to therapy.”

“While the number of CV events in the pooled phase trials was limited, the early, large, and statistically significant reductions in MACE are highly encouraging. We look forward to initiating a differentiated cardiovascular outcomes trial to further explore and confirm these findings.”

About Lerodalcibep

Lerodalcibep is a novel, small protein-binding, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly, single small-volume, subcutaneous injection that will not require refrigeration at home or in travel. These features make Lerodalcibep a unique alternative to approved PCSK9 inhibitors. The anti-PCSK9 binding domain of Lerodalcibep is an 11-kDa polypeptide called an adnectin, engineered for high-affinity subnanomolar binding to human PCSK9 and fused to human serum albumin to enhance plasma half-life.

In clinical trials, Lerodalcibep has demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very-high or high risk of, cardiovascular disease (CVD) and ≥50% in those with heterozygous familial hypercholesterolemia (FH) who have more severe LDL-C elevations, and is expected to expand treatment options for the millions of patients around the world with CVD, including the 30 million individuals with FH.

The global Phase 3 LIBerate program enrolled a diverse population of over 2,900 patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia. Lerodalcibep was dosed once monthly for up to 52 weeks in these key registration-enabling, placebo-controlled trials, and over 2,400 patients have continued in the 72-week open-label extension trial. Following the FDA BLA submission, LIB is preparing a Marketing Authorization Application to the European Medicines Agency.

LIB submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in December 2024, and received formal filing by FDA in February with and anticipated PDUFA date in mid Dec this year. LIB is seeking approval of lerodalcibep to reduce LDL-C for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), or very high or high risk of ASCVD, and primary hyperlipidemia, including heterozygous and homozygous familial hypercholesterolemia (HeFH / HoFH).

About LIB Therapeutics Inc.

LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing Lerodalcibep to the millions of patients with cardiovascular disease and to the 30 million individuals with familial hypercholesterolemia (FH) around the world, who require additional large reductions in LDL-C, despite maximally tolerated statins and other lipid lowering agents, to achieve LDL-C goals.

For more information, please visit: www.libtherapeutics.com.

Contacts

Kate Caldwell

[email protected]