China-based Hasten Biopharmaceutical Co., Ltd, a comprehensive biopharmaceutical company co-established by CBC Group, has announced the first subject dosing in its Phase III clinical study for lerodalcibep, a third-generation PCSK9 inhibitor. The drug was in-licensed from US firm LIB Therapeutics Inc. in September of the previous year.
Study Design and Objectives
The Phase III study is a randomized, double-blinded, placebo-controlled trial designed to assess the efficacy and safety of HST101 in Chinese patients with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). This significant trial is being led by Peking University First Hospital and is conducted across 35 centers nationwide, enrolling over 2700 patients. The study includes a diverse patient population, such as cardiovascular disease (CVD) patients, high-risk and extremely high-risk CVD patients, as well as patients with heterozygous and homozygous familial hypercholesterolemia (FH).
Lerodalcibep’s Profile and Upcoming Milestones
Lerodalcibep, a fusion protein administered subcutaneously once monthly, is designed to treat patients with hyperlipidemia. The drug is currently being prepared for a Biological License Application (BLA) in the United States, indicating its potential to impact the global market for hypercholesterolemia treatments.-Fineline Info & Tech
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