LIB Therapeutics Announces Positive Results from LIBerate-HR Study: A 52-Week, Placebo-Controlled Registration-Enabling Trial of Lerodalcibep at Late-Breaking Session at American College of Cardiology 2024

CINCINNATI--(BUSINESS WIRE)-- LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, announced positive results from two studies in the recently completed Phase 3 LIBerate registration-enabling program were presented at the American College of Cardiology 2024 in Atlanta, Georgia on April 6-8, 2024.

Phase 3 LIBerate-HR (High Risk) Study
Late-Breaker Oral Presentation by Professor Eric Klug (Lead Investigator), April 7

The global Phase 3 LIBerate-HR (high risk) study with 922 patients was a randomized, double-blind, placebo-controlled trial to evaluate Lerodalcibep 52-week efficacy and safety in patients with, or at very high or high risk, for cardiovascular disease on stable lipid-lowering therapy. The co-primary efficacy endpoints were the percent change from baseline in LDL-C at Week 52 and the mean of Weeks 50 and 52. Secondary efficacy outcomes included additional lipid, apolipoproteins, free PCSK9 and achievement of LDL-C targets.

Patients were randomized 2:1 to a single 300 mg (1.2 mL subcutaneous) once-monthly dose of Lerodalcibep or placebo for 52 weeks. Approximately 50% participants were very-high or high risk primary prevention and nearly half were female. Mean baseline LDL-C was ~116 mg/dL despite > 80% of patients on statins and > 16% on ezetimibe.

Results:

• Co-primary endpoint achieved with Lerodalcibep: significant and persistent LDL-C reductions over 52 weeks of 56% (60.6 mg/dL) at Week 52 and 62% (74.5 mg/dL) at mean of Weeks 50 and 52
• Over 90% of all patients achieved the new more stringent ESC targets during the study of ≥ 50% reduction in LDL-C from baseline and recommended LDL-C targets of < 55 mg/dL with CVD or very high risk or < 70 mg/dL if at high risk
• Lerodalcibep robustly reduced non-HDL-C 47%, Apo B 43%, Lp(a) 33%
• Lerodalcipeb was well tolerated. Treatment-emergent adverse events were similar between Lerodalcibep and placebo, with the most common being mild to moderate injection site reactions, and no difference in discontinuations: Lerodalcibep (4.2%) vs placebo (4.6%)
• Lerodalcibep was not associated with in vivo active ADAs or Nabs. There was no attenuation of either free PCSK9 suppression or LDL-C efficacy

“The results presented at ACC 2024 are part of a global Phase 3 LIBerate program for Lerodalcibep, a large and comprehensive registration-enabling package with a diverse global population of patients with CVD, without CVD but at very high and high risk for CVD, as well as heterozygous and homozygous familial hypercholesterolemia (FH) which should support a broad label upon approval,” said Dave Kallend, MBBS, Chief Medical Officer of LIB Therapeutics. “We are grateful to the many investigators and patients around the world who contributed to successfully enroll and complete the Phase 3 LIBerate registration-enabling program.”

Phase 3 Open-Label Extension (OLE) Study in HeFH
Oral Moderated Poster by Dr. Evan Stein, April 7

The longer-term safety and efficacy from the open-label extension trial, LIBerate-OLE, in heterozygous FH subjects who completed the prior 24-week, placebo-controlled LIBerate-HeFH study¹ and continued on Lerodalcibep or switched from placebo to active drug for 48 weeks was presented. Of 478 participants in the base LIBerate-HeFH trial, 421 (88%) continued into the OLE trial: 281 patients on Lerodalcibep and 140 on placebo. All participants received open-label Lerodalcibep 300 mg in a subcutaneous 1.2 mL once-monthly dose starting immediately upon completion of the base trial. Approximately 90% of patients were on background statins and 51% on ezetimibe.

After 48 weeks of OLE treatment, mean % LDL-C reductions with Lerodalcibep from baseline in the base trial was 48.5% (ITT population). This compared favorably with the 50% reduction from baseline in the 24-week base trial where the placebo group increased 8% resulting in a placebo-adjusted mean reduction of 58.6%.¹ Robust reductions in non-HDL cholesterol, Apo B, and Lp(a), consistent with the reductions in the base trial, were also demonstrated. Importantly, Lerodalcibep, dosed monthly for an additional 48 weeks and up to 18 months in total, significantly and persistently reduced LDL-C with no attenuation in subjects with HeFH. Apart from minor injection site reactions, none of which were severe or persistent, there were no significant additional safety concerns.

“Lerodalcibep has a potential best in class LDL-C lowering profile and will be differentiated as a more convenient and patient-friendly, once-monthly, small-volume, single subcutaneous injection stable at ambient temperature that will not require refrigeration at home or in travel,” said David Cory, CEO of LIB Therapeutics. “We look forward to submitting a Biologics License Application to the Food and Drug Administration followed by a Marketing Authorization Application to the European Medicines Agency, as Lerodalcibep steps closer to being made available to patients in need of additional LDL-C lowering to reach target goals.”

About Lerodalcibep

Lerodalcibep, a novel, potent, small binding protein, third-generation PCSK9 inhibitor, has been developed as a more convenient, once-monthly dose in a small injection volume and with long-ambient stability. Combined with sustained LDL-C reductions demonstrated in clinical trials, Lerodalcibep is expected to expand treatment options for the millions of patients around the world with atherosclerotic cardiovascular disease (ASCVD), and those at very high and high risk for ASCVD, including the 30 million individuals with more severe inherited high-cholesterol called familial hypercholesterolemia (FH).

The global Phase 3 LIBerate program with over 2,700 patients enrolled a diverse population of patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia (FH). Key registration placebo-controlled trials included Lerodalcibep once-monthly for up to 52 weeks, and over 2,400 patients continued in the 72-week open-label extension trial. LIB is preparing a biologics license application (BLA) for Lerodalcibep and plans for regulatory submission in 2024.

About LIB Therapeutics Inc.

LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing novel, safe and convenient subcutaneous and oral PCSK9 inhibitors to the millions of patients with cardiovascular disease and the 30 million individuals with familial hypercholesterolemia (FH), who require additional large reductions in low density lipoprotein-cholesterol (LDL-C) despite maximally tolerated statins and other lipid lowering agents.

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

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