An evaluation of recaticimab for the treatment of hypercholesterolemia.

IF 3.6 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Expert Opinion on Biological Therapy Pub Date : 2025-05-22 DOI:10.1080/14712598.2025.2508837

Xuan L Tang, Amanda J Hooper, John R Burnett

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引用次数: 0

Abstract

Introduction: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, by preventing the degradation of LDL receptors, either through interference in the binding of PCSK9 to LDL receptors or through silencing of PCSK9 at a molecular level, have revolutionized lipid-lowering treatment and offer the opportunity to further improve clinical outcomes for patients with hypercholesterolemia.

Areas covered: We discuss the role of PCSK9 as a therapeutic target for hypercholesterolemia, describe the pharmacodynamics, pharmacokinetics, and metabolism of recaticimab, and report the recent clinical trials with this 'humanized' IgG1 monoclonal antibody (mAb) against PCSK9.

Expert opinion: Recaticimab has a high affinity for PCSK9 that confers a prolonged duration of action. Recaticimab durably decreases LDL-cholesterol, non-HDL-cholesterol and apoB, but can also lower Lp(a). Recaticimab may offer advantages over current mAbs in clinical use in terms of its long half-life, dosing interval of up to 12 weeks, and potentially a lower cost; however, long-term concerns regarding immunogenicity remain. Longer-term studies in a variety of more diverse patient cohorts will be needed to further evaluate the efficacy, safety, and durability of recaticimab and to ascertain the optimal dosing schedule for cardiovascular outcome studies.

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recaticimab治疗高胆固醇血症的评价。

Proprotein convertase subtilisin/ keexin type 9 （PCSK9）抑制剂，通过干扰PCSK9与LDL受体的结合或在分子水平上沉默PCSK9来阻止LDL受体的降解，已经彻底改变了降脂治疗，并为进一步改善高胆固醇血症患者的临床结果提供了机会。涉及领域：我们讨论了PCSK9作为高胆固醇血症治疗靶点的作用，描述了recaticimab的药效学、药代动力学和代谢，并报告了最近使用这种“人源化”IgG1单克隆抗体（mAb）对抗PCSK9的临床试验。专家意见：Recaticimab对PCSK9具有高亲和力，可延长作用时间。recatiimab能持久降低低密度脂蛋白胆固醇、非高密度脂蛋白胆固醇和载脂蛋白ob，但也能降低Lp(a)。Recaticimab的半衰期长，给药间隔长达12周，并且潜在的成本较低，在临床使用方面可能比目前的单克隆抗体具有优势，然而，长期的免疫原性问题仍然存在。为了进一步评估recaticimab的疗效、安全性和持久性，并确定心血管结局研究的最佳给药方案，需要在各种更多样化的患者队列中进行长期研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Biological Therapy 医学-生物工程与应用微生物

CiteScore

8.60

自引率

0.00%

发文量

审稿时长

3-8 weeks

期刊介绍： Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.