- Lerodalcibep is a novel, adnectin-based, small protein-binding, third-generation PCSK9 inhibitor

- Only once-monthly, single, self-administered PCSK9i; no refrigeration required at home or in travel

- Patient-friendly features designed to enhance adherence to reach and maintain LDL-C goals

CINCINNATI, Ohio, December 16, 2024 / BUSINESS WIRE / -- LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of Lerodalcibep to reduce low-density lipoprotein cholesterol (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). Lerodalcibep is a novel, adnectin-based, small protein-binding, third-generation PCSK9 inhibitor, developed as a more patient-friendly, once-monthly, selfadministered, single small-volume, subcutaneous injection with long-ambient stability alternative to approved PCSK9 inhibitors.

Dr. Shen XIAO, Hasten CMO, said,“Congratulations to our partner LIB for achieving an important milestone in advancing Lerodalcibep as an promising LDL-C lowering treatment. Recently Hasten also welcomed the first subject enrolled for dosing in the Phase III clinical trial and expects Lerodalcibep a rather good performance in the clinical trial, so as to allow us to bring this innovative therapy to Chinese patients soon. We believe that together with LIB, we will jointly promote the early implementation of innovative therapies for hypercholesterolemia, and provide doctors and patients with new treatment options of greater clinical value.”

"There remains a large unmet need among millions of patients with cardiovascular disease, or at high cardiovascular risk, including the 30 million people with inherited high cholesterol, who are unable to reach optimal LDL cholesterol levels with current oral therapies," said Dr. Evan Stein, Founder, Chief Operating and Scientific Officer of LIB Therapeutics. “Lerodalcibep has demonstrated robust and sustained long-term LDL cholesterol-lowering as well as enabling the vast majority of patients to achieve the more stringent lower LDLcholesterol targets in global guidelines across clinical trials. Lerodalcibep also offers a once-monthly, single small subcutaneous dose with excellent tolerability, combined with long ambient stability not requiring refrigeration by patients. These factors are anticipated to achieve better patient adherence to the life-long treatment required to control LDL cholesterol.” 

“As planned, the Lerodalcibep BLA has been submitted to the FDA, and we are now preparing a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for submission by mid-2025,” said David Cory, CEO of LIB Therapeutics. “We look forward to working with regulators to make Lerodalcibep available to patients around the world. In parallel, we are focused on organizational preparedeness for commercial launch and will provide details in the future. Lerodalcibep is a potential best-in-class PCSK9 inhibitor that will enter a growing global PCSK9 market on target to reach $5B in 2025. Most importantly, Lerodalcibep will introduce a patient-friendly treatment option to achieve the new guideline-directed, lower LDL-C goals.”

The BLA is supported by a development program of 2,900 patients, including five global Phase 3 registration studies known collectively as the LIBerate program. These studies included more than 2,300 patients on maximally tolerated statin and other oral agents, requiring additional additional LDL cholesterol reduction. The Phase 3 LIBerate studies evaluated the safety and efficacy of Lerodalcibep in patients with cardiovascular disease (CVD), or at very high or high risk for CVD including patients with HeFH and HoFH. Lerodalcibep was dosed once monthly for up to 52 weeks in these key registration-enabling, double-blind, placebo-controlled trials, and over 2,400 patients have continued in the 72-week open-label extension trial.

Lerodalcibep, a novel third-generation PCSK9 inhibitor, is the first innovator in research introduced by Hasten in September, 2023, which highly synergizes with the company’s existing seven classic originator drugs to strengthen its product portfolio in the field of chronic and acute diseases. In November, 2024, Lerodalcibep completed the enrollment and dosing of the first subject in the domestic Phase III clinical trial under the full promotion of Hasten.

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. 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 registrationenabling, 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.

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 low density lipoproteincholesterol (LDL-C), despite maximally tolerated statins and other lipid lowering agents, to achieve LDL-C goals. For more information, please visit: www.libtherapeutics.com.