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 from Late Breaking Science presentations at the November 7-10th 2025 American Heart Association meeting in New Orleans.

• Long-term Efficacy and Safety of Lerodalcibep in the Open-label 72-week Extension Study of Subjects Previously on Inclisiran or Lerodalcibep in the LIBerate-VI Trial – Dr Evan Stein MD PhD November 9th

• Lerodalcibep demonstrated consistent long-term efficacy in those continued on the drug and was well tolerated, with no treatment related serious adverse events.
• 72-week primary endpoint; mean & absolute LDL-C reductions of 59.2% & 66.6 mg/dL respectively.
• Mean ApoB was reduced by 45.3% and median Lp(a) by 35.5%.
• Subjects switched from Inclisiran to Lerodalcibep had:

• Substantial additional LDL-C reductions from the end of the base trial of ~40% through week 48 and 30% lower through week 72.
• Additional large reductions in Apo B and Lp(a) and
• Significant increase in subjects achieving guideline LDL-C targets.

“The study is the first to assess a plasma binding PCSK9 inhibitor, Lerodalcibep, in patients switched from a hepatic PCSK9 synthesis inhibitor and which showed synergistic efficacy, further reducing LDL-C, Apo B and Lp(a) and increased patients ability to achieve the new more stringent LDL-C guideline targets,” said Dr. Evan Stein MD PhD, Chief Executive and Scientific Officer of LIB Therapeutics and continued. “The results are consistent with combined inhibition of circulating free PCSK9 from non-hepatic and reduced hepatic synthesis and provides an additional pathway to achieving treatment lipid goals in the many patients who cannot achieve them with current therapies. Significant additional studies are required to determine the optimal dosing frequency and safety of combining these therapies.”

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-clockwise binding domain of Lerodalcibep is an 11-kDa polypeptide called an accenting, 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 VHF.

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.

LIB submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) in December 2024, and received formal filing by FDA in February with an anticipated PDUFA date on target for mid December this year. LIB is seeking approval of Lerodalcibep (LEROCHOL®) as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Marketing Authorization Application was submitted to, and accepted by the European Medicines Agency in May with anticipated approval in June 2026.

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 stains and other lipid lowering agents, to achieve LDL-C goals.

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

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