LIB Therapeutics Announces Completion of the Global Phase 3 LIBerate Program of Lerodalcibep, a Novel Third-Generation PCSK9 Inhibitor in Development for Cardiovascular Disease

• Last Patient Last Visit completed for final two 52-week placebo-controlled Phase 3 trials, LIBerate-CVD (N=922) and LIBerate-HR (N=922)
• Phase 3 LIBerate registration-enabling program now completed, including four key studies (N=2,387)
• >2,200 patients rolled-over into Phase 3 LIBerate-OLE, a 72-week, open-label extension study
• Biologics License Application and Marketing Authorization Application submissions planned 1H 2024

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company developing Lerodalcibep, a novel, third-generation PCSK9 inhibitor for patients at very high and high risk of cardiovascular disease (CVD), today announced completion of LIBerate-CVD and LIBerate-HR, the final two registration-enabling Phase 3 trials for patients with CVD or at very high and high risk of CVD. These two trials are part of the registration-enabling Phase 3 LIBerate Program which includes four key studies of 2,387 patients dosed for up to 52 weeks, with >2,200 patients continuing in an open-label extension study of 72 weeks.

“The global Phase 3 LIBerate program for Lerodalcibep is a large and comprehensive registration-enabling package and includes a diverse global population of patients with CVD, without CVD but at very high and high risk for CVD, and heterozygous and homozygous familial hypercholesterolemia (FH) which should support a broad label upon approval,” said David Kallend, MBBS, Chief Medical Officer of LIB Therapeutics. “We look forward to working with regulators to submit a biologics license application to the Food and Drug Administration and marketing authorization application to the European Medicines Agency in 1H 2024.”

Evan Stein, MD, PhD, Co-Founder, Chief Scientific and Operating Officer of LIB Therapeutics, added, “We are grateful to the many investigators and patients around the world who put in tremendous efforts during the global COVID-19 pandemic to successfully enroll and complete the Phase 3 LIBerate registration-enabling program.”

"Lerodalcibep has a compelling, emerging clinical efficacy and a patient-friendly profile which differentiates itself as a single, once-monthly, small-volume, subcutaneous injection that will not require at-home refrigeration for patient convenience,” said David Cory, Chief Executive Officer of LIB Therapeutics. “The growing PCSK9 market will approach $3 billion in global sales in 2023 and is projected to be $5 billion in 2025 when we anticipate approval and launch. We look forward to making this exciting new therapy available for patients and healthcare providers in the future.”

About Lerodalcibep

Lerodalcibep is a novel, third-generation, PCSK9 inhibitor in development to overcome the limitations of current low density lipoprotein-cholesterol (LDL-C) lowering treatments, including statins and ezetimibe, to achieve the lower LDL-C targets in recently updated national and international guidelines to treat and prevent cardiovascular disease (CVD). Lerodalicibep is being developed as a convenient, small-injection volume, once monthly dose 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).

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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