LIB Therapeutics Files FDA Application for Groundbreaking LDL-C Treatment

LIB Therapeutics Advances LDL-Cholesterol Treatment

CINCINNATI--LIB Therapeutics Inc. (LIB), a late-stage biopharmaceutical company, has recently announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). This application seeks approval for Lerodalcibep, intended to significantly reduce low-density lipoprotein cholesterol (LDL-C) in patients suffering from atherosclerotic cardiovascular disease (ASCVD) or those at very high to high risk of ASCVD, including those with primary hyperlipidemia such as familial hypercholesterolemia (HeFH and HoFH).

Understanding Lerodalcibep: A Revolutionary Treatment

Lerodalcibep stands out as a novel, adnectin-based, small protein-binding, third-generation PCSK9 inhibitor. It offers a more convenient treatment option with its once-monthly, self-administered subcutaneous injection. This treatment solution possesses long-ambient stability, which simplifies administration for patients compared to existing PCSK9 inhibitors that require more frequent dosing.

Addressing the Unmet Needs of Cardiovascular Patients

Dr. Evan Stein, Founder, Chief Operating and Scientific Officer of LIB Therapeutics, emphasized the persistent unmet medical needs in the field of cardiovascular disease. “There are millions of patients, including approximately 30 million with inherited high cholesterol, who struggle to reach optimal LDL cholesterol levels with available oral therapies,” he noted. Lerodalcibep has exhibited impressive long-term LDL cholesterol reduction effects and has success in helping patients meet more stringent LDL-cholesterol targets set forth by global health guidelines during clinical trials.

Looking Forward: Submissions and Strategies

In a proactive move, the BLA for Lerodalcibep has been submitted to the FDA, and LIB Therapeutics is also preparing a Marketing Authorization Application (MAA) for the European Medicines Agency (EMA), targeting submission by mid-2025. David Cory, CEO of LIB Therapeutics, expressed the company's eagerness to collaborate with regulators to make Lerodalcibep available to patients globally. He also highlighted the importance of being ready for a commercial launch, indicating that further details will be shared in due course.

Strategic Positioning in a Growing Market

Lerodalcibep has the potential to be a best-in-class PCSK9 inhibitor amid a rapidly expanding global market projected to reach $5 billion by 2025. Importantly, it aims to provide a patient-friendly alternative designed to help individuals achieve the lower LDL-C goals recommended by health guidelines.

Strong Clinical Evidence Behind the Application

The BLA submission is grounded in robust clinical evidence, supported by an extensive development program involving 2,900 patients across five pivotal global Phase 3 registration studies known as the LIBerate program. These studies investigated the safety and efficacy of Lerodalcibep among patients with cardiovascular disease and those at high risk for cardiovascular complications, including patients with familial hypercholesterolemia. Participants received the treatment once monthly for up to 52 weeks in double-blind, placebo-controlled trials, with more than 2,400 patients continuing into a 72-week open-label extension trial.

Innovative Features of Lerodalcibep

The design of Lerodalcibep, a small protein-binding PCSK9 inhibitor, addresses major barriers in current therapies. Its administration method requires no refrigeration, which offers convenience to users, especially during travel. Additionally, the anti-PCSK9 binding domain of Lerodalcibep, an engineered 11-kDa polypeptide called an adnectin, aims for high-affinity binding to human PCSK9, which enhances its overall efficacy.

About LIB Therapeutics Inc.

LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to advancing innovative therapies for patients with cardiovascular diseases, particularly those with familial hypercholesterolemia who need significant reductions in LDL-C despite existing therapies. Committed to enhancing patient experiences and outcomes, LIB Therapeutics focuses on pioneering approaches that align with patients' needs.

Frequently Asked Questions

What is Lerodalcibep and how does it work?

Lerodalcibep is a novel treatment designed to lower LDL cholesterol in patients with cardiovascular disease, utilizing a unique once-monthly injection method.

Who are the target patients for Lerodalcibep?

The primary candidates include individuals with atherosclerotic cardiovascular disease, those at high risk of such diseases, and patients with familial hypercholesterolemia.

What makes Lerodalcibep different from other treatments?

Lerodalcibep offers a more convenient dosing schedule and storage requirements, making it patient-friendly and easier for individuals to adhere to their treatment plans.

What is the significance of the FDA submission?

The BLA submission is a crucial step in bringing Lerodalcibep to market, potentially offering new hope for patients who have not achieved LDL-C management with current therapies.

What are LIB Therapeutics' future plans following the BLA?

LIB Therapeutics plans to file additional applications with the European Medicines Agency and continue preparing for a commercial launch while updating stakeholders on progress.

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