A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W [≤31 days]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) or very-high/high risk for ASCVD including Heterozygous familial hypercholesterolemia (HeFH) on a stable diet and oral LDL-C lowering drug therapy, followed by 36-week open-label treatment with subsequent 4-week follow-up for total 52-week long-term safety and efficacy evaluation.

开始日期2024-11-16

申办/合作机构

Hasten Biopharmaceutical Co., Ltd.

CTR20242095

/ Recruiting临床3期

评价HST101在中国高胆固醇血症患者中有效性和安全性的随机、双盲、安慰剂对照的Ⅲ期临床研究

本研究的主要目的是评估HST101在接受稳定饮食和中等或高强度他汀类药物或其他口服降脂药物治疗的中国高胆固醇血症患者（包括HeFH）中的有效性和安全性。

开始日期2024-11-08

申办/合作机构

Hasten Biopharmaceutical Co., Ltd.

[+3]

NCT06504043

/ Enrolling by invitation临床1期

A Randomized, Double-Blind, Placebo-Controlled, Single-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of HST101 in Healthy Chinese Study Participants With Elevated LDL-C Levels

This is a single-center, randomized, double-blind, placebo-controlled, single HST101 SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Chinese Participants with Elevated LDL-C Levels.

开始日期2024-09-17

申办/合作机构

Hasten Biopharmaceutical Co., Ltd.

100 项与莱达西贝普相关的临床结果

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100 项与莱达西贝普相关的转化医学

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100 项与莱达西贝普相关的专利（医药）

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项与莱达西贝普相关的文献（医药）

2025-03-01·The Lancet Diabetes & Endocrinology

Lerodalcibep and evolocumab for the treatment of homozygous familial hypercholesterolaemia with PCSK9 inhibition (LIBerate-HoFH): a phase 3, randomised, open-label, crossover, non-inferiority trial

Article

作者: Vest, Jeffrey ; Blom, Dirk ; Caldwell, Kate ; Stein, Evan A ; Kallend, David ; Raal, Frederick J ; Daniels, Chris ; Turner, Traci ; Bahassi, El Mustapha ; Elis, Avishay ; Kayikcioglu, Meral ; Gupta, Preeti ; Mitchell, Tracy ; Mehta, Vimal

BACKGROUNDLerodalcibep, a small binding anti-PCSK9 protein (adnectin), showed effective LDL cholesterol reduction in heterozygous familial hypercholesterolaemia. We aimed to assess the safety and efficacy of lerodalcibep and evolocumab in a globally diverse homozygous familial hypercholesterolaemia population.METHODSThis phase 3, randomised, open-label, crossover, non-inferiority study consisted of two 24-week treatment periods separated by an 8-week washout. The study was conducted in 12 lipid clinics in six countries (India, Israel, Norway, South Africa, Türkiye, and the USA). Patients aged 10 years or older with genetically confirmed homozygous familial hypercholesterolaemia were randomly assigned by computer-generated randomisation scheme performed centrally via interactive response technology to either monthly lerodalcibep 300 mg (1·2 mL subcutaneous injection) or monthly evolocumab 420 mg (subcutaneous 9 min infusion of 3·5 mL) for 24 weeks (period A) followed by an 8-week washout and then crossed over to the alternate therapy for the next 24 weeks (period B). The trial was open label, but all efficacy parameters were masked to patients, study staff, and the sponsor from randomisation. The primary efficacy endpoint was the percent change from baseline (day 1 of period A) in LDL cholesterol concentration to week 24 for period A and B. The intention-to-treat (ITT) population, defined as all randomly assigned patients, was used for the primary analysis. The safety population included all patients who received any study medication. The margin used to establish non-inferiority was 6%. The trial is registered with ClinicalTrials.gov (NCT04034485) and EudraCT (2019-003611-62), and has now finished.FINDINGSPatients were enrolled from Nov 11, 2019, to July 2, 2021, and the final study visit took place on Aug 8, 2022. Of 82 patients screened, 66 entered period A (ITT population). The mean age was 28·7 years (SD 15·2); 20 (30%) of 66 were paediatric patients; 36 (55%) of 66 were female and 30 (45%) of 66 were male; and the mean baseline LDL cholesterol was 10·59 mmol/L (SD 4·37). Mean LDL cholesterol reduction by ITT analysis at week 24 was -4·9% (SE 3·5) on lerodalcibep compared with -10·3% (3·5) on evolocumab; the mean difference between treatments was 5·4% (95% CI -0·2 to 11·1), which did not show non-inferiority at the prespecified 6% margin. LDL cholesterol response varied considerably across the patient population but was generally similar in the same patients with both lerodalcibep and evolocumab. When averaged across all monthly visits, LDL cholesterol response was -9·1% (SE 3·2) on lerodalcibep and -10·8% (3·2) on evolocumab. Importantly, genotyping and free PCSK9 suppression were not predictive of response. Both drugs were well tolerated, with no treatment-related serious adverse events. Injection site reactions were reported in one (2%) of 65 patients on lerodalcibep and 15 (24%) of 62 patients on evolocumab.INTERPRETATIONThe LDL cholesterol response was highly variable, but generally similar in patients treated with both lerodalcibep and evolocumab. Importantly, the study showed the inability to predict response based on genotyping, reinforcing the rationale for PCSK9 inhibition in all patients with homozygous familial hypercholesterolemia and continuing its use in responders.FUNDINGLIB Therapeutics.

2024-09-01·JAMA Cardiology

Efficacy and Safety of Lerodalcibep in Patients With or at High Risk of Cardiovascular Disease

Article

作者: Llerena, Sara ; Kallend, David ; Burgess, Lesley J. ; Caldwell, Kate ; Fourie, Nyda ; Vest, Jeff ; Stein, Evan A. ; Scott, Russell ; Klug, Eric Q.

ImportanceRecent changes in national and international lipid guidelines for reducing cardiovascular events recommend additional drugs, greater reductions, and lower targets for low-density lipoprotein cholesterol (LDL-C) if not attained with statins. The achievement of these targets with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors has not yet been evaluated in a randomized clinical trial.ObjectiveTo evaluate the 52-week safety and efficacy of lerodalcibep, a small anti–PCSK9-binding protein, in patients with cardiovascular disease (CVD) or who are at very high or high risk of CVD and requiring addition LDL-C–lowering treatment.Design, Setting, and ParticipantsThis was a randomized, double-blind, placebo-controlled phase 3 trial. The trial was conducted at 66 clinics in 11 countries between April 23, 2021, and November 15, 2023. Individuals 18 years and older taking maximally tolerated statin therapy with LDL-C of 70 mg/dL or greater with CVD or 100 mg/dL or greater if at high risk of CVD were included.InterventionsPatients were randomized 2:1 to monthly 1.2-mL subcutaneous lerodalcibep, 300 mg, or placebo for 52 weeks.Main Outcomes and MeasuresThe safety analysis included all randomized patients. The co-primary efficacy end points were percent change from baseline in LDL-C at week 52 and the mean of weeks 50 and 52. Secondary efficacy outcomes included additional lipid apolipoprotein measures and achievement of guideline-recommended LDL-C targets.ResultsOf 922 randomized participants (mean [range] age, 64.5 [27-87] years; 414 [44.9%] female; mean [SD] baseline LDL-C, 116.2 [43.5] mg/dL), 811 (88%) completed the trial. The mean (SE) placebo-adjusted reduction in LDL-C with lerodalcibep by modified intention-to-treat (mITT) analysis was 56.2% (2.2%) at week 52 and 62.7% (1.9%) for the mean of weeks 50 and 52; 49.7% (2.4%) and 55.3% (2.2%) by ITT with imputation using a washout model, and 60.3% (2.3%) and 65.9% (1.9%) by per-protocol analysis at week 52 and the mean of weeks 50 and 52, respectively (P &lt; .001 for all). With lerodalcibep, 555 of 615 participants (90%) achieved both a reduction in LDL-C of 50% or greater and recommended LDL-C targets during the study. Treatment-emergent adverse events were similar between lerodalcibep and placebo, except for injection site reactions. These occurred in 42 of 613 participants receiving lerodalcibep (6.9%) compared to 1 of 307 receiving placebo (0.3%), were graded mild or moderate, and did not result in higher discontinuation of treatment, at 26 of 613 (4.2%) and 14 of 307 (4.6%), respectively. Sporadic in vitro antidrug antibodies were detected, which had no impact on free PCSK9 or LDL-C–lowering efficacy.Conclusions and RelevanceIn this trial, lerodalcibep, a novel anti-PCSK9 small binding protein, dosed monthly and stable at ambient temperatures significantly reduced LDL-C in patients with CVD or at high risk of atherosclerotic cardiovascular disease with a safety profile similar to placebo. These results support long-term use of lerodalcibep in patients with CVD or at high risk of CVD who are unable to achieve adequate LDL-C reduction while receiving maximal tolerated statins alone.Trial RegistrationClinicalTrials.gov Identifier: NCT04806893

2024-08-01·Current Atherosclerosis Reports

Highlights of Cardiovascular Disease Prevention Studies Presented at the 2024 American College of Cardiology Conference

Review

作者: Meloche, Chelsea ; Khoja, Adeel ; Vaughan, Elizabeth M ; Hermel, Melody ; Sheikh, Sana ; Virani, Salim S ; Rawlley, Bharat ; Dalakoti, Mayank ; Slipczuk, Leandro ; Gupta, Kartik ; Minhas, Abdul Mannan Khan

PURPOSE OF REVIEWTo summarize selected late-breaking science on cardiovascular (CV) disease prevention presented at the 2024 Scientific Session of the American College of Cardiology (ACC) conference.RECENT FINDINGSThe LIBerate-HR trial showed the efficacy and safety of lerodalcibep, a subcutaneous injection that prevents binding of Pro-Protein Convertase Subtilisin/Kexin (PCSK) 9 to low-density lipoprotein (LDL)-receptors resulting in LDL-cholesterol (LDL-C) lowering in patients at very high risk or high risk of atherosclerotic CV disease (ASCVD). The AEGIS-II randomized patients with type 1 myocardial infarction (MI) with multivessel coronary artery disease and additional CV risk factors and found no benefit in major adverse CV events (MACE) with CSL112, an apolipoprotein A1 infusion shown to increase cholesterol efflux capacity. The Bridge-TIMI 73a trial showed a significant reduction in triglyceride (TG) levels with olezarsen, an antisense mRNA, in patients with moderate hyperTG with elevated CV risk. The BE ACTIVE trial showed significant improvement in step counts in patients given behavioral and financial incentives. The DRIVE study showed a significant increase in the prescription of either sodium-glucose co-transporter-2 inhibitors or glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes mellitus (T2DM) at elevated CV or renal risk with a remote team-based, non-licensed navigator and clinical pharmacist approach. The TACTiC trial showed increased and sustained use of statin therapy by patient-driven use of a web-based portal that calculated the ASCVD risk score and gave prompts. The VICTORIAN-INITIATE trial showed efficacy and safety in early use of inclisiran in patients with ASCVD who did not reach target LDL-C < 70 mg/dL despite maximally tolerated statin therapy. The ARISE-HF trial showed no difference in change of peak oxygen consumption with the use of an oral aldose reductase inhibitor, AT-001, in patients with well-controlled T2DM and diabetic cardiomyopathy with high-risk features compared to placebo. The PREVENT trial showed a significant reduction in target vessel failure at 2 years in patients with non-flow limiting vulnerable plaques with percutaneous coronary intervention and optimal medical therapy (OMT) compared to OMT alone. The late-breaking clinical science presented at the 2024 Scientific Session of the ACC paves the way for an evidence-based alternative to statin therapy and provides data on several common clinical scenarios encountered in daily practice.

项与莱达西贝普相关的新闻（医药）

2025-02-12

·海森生物

海森生物美国合作伙伴LIB Therapeutics宣布其生物制品Lerodalcibep上市申请获FDA受理

■ Lerodalcibep用于治疗成人动脉粥样硬化性心血管疾病（ASCVD），或其极高危或高危患者，包括杂合子型家族性高胆固醇血症（HeFH）患者，以及成人和10岁以上儿童的纯合子型家族性高胆固醇血症（HoFH）患者 ■ FDA 根据《处方药使用者付费法案》（PDUFA）确定的批准日期为2025年12月12日 ■ 目前FDA没有召开咨询委员会会议讨论该申请的计划 2025年2月10日，海森生物重要合作伙伴LIB Therapeutics Inc.（以下简称LIB）宣布美国食品和药物监督管理局（FDA）已受理Lerodalcibep的生物制剂许可证申请（BLA）。Lerodalcibep旨在降低低密度脂蛋白胆固醇（LDL-C）从而治疗动脉粥样硬化性心血管疾病（ASCVD）或其极高危或高危患者和原发性高脂血症，包括杂合子型以及10岁或以上的纯合子型家族性高胆固醇血症（HeFH/HoFH）患者的治疗。 Lerodalcibep是一种基于Adnectin设计的分子量较低的融合蛋白制剂，是新型第三代PCSK9抑制剂，具有常温环境下长期稳定的特质。由于其具备方便患者自行用药、每月一次、单次小容量皮下注射的特点，有望替代已批准的 PCSK9 抑制剂，成为临床新选择。根据《处方药使用者付费法案》（PDUFA），FDA确定的批准日期为2025年12月12日，目前没有召开咨询委员会会议讨论该申请的计划。肖申海森生物医药有限公司首席医学官、博士作为合作伙伴，海森生物非常欣喜地看到LIB在推动Lerodalcibep尽快成为全球心血管疾病患者和家族性高胆固醇血症患者新疗法的进程中取得了里程碑式进展。伴随着国内III期临床试验稳步进行，相信海森生物与LIB的携手将能够促使高胆固醇血症创新疗法早日落地，为医患提供更具临床价值的治疗新选择。 LIB创始人、首席运营兼科学官Evan Stein博士表示：目前的口服疗法无法使数以百万计心血管疾病患者或心血管疾病高危人群的低密度脂蛋白胆固醇达到当前指南推荐的目标，这其中包括3,000万遗传性高胆固醇患者，仍有大量未被满足的需求。 Lerodalcibep已显示出强效且持久降低LDL-C的作用，使绝大多数患者能够在临床试验中以优异的安全性和依从性实现这些更严格更低的低密度脂蛋白胆固醇目标。我们期待着与监管机构合作，早日让Lerodalcibep 惠及全球各地患者。 LIB首席执行官David Cory表示： Lerodalcibep作为潜在的同类最佳PCSK9抑制剂，具备每月一次、单次小剂量皮下注射的特点，结合其环境温度下的长期稳定性，不需要在家或旅行中冷藏，为患者提供了一种更友好的治疗选择，以便其实现新的更低的LDL-C目标。 LIB运营团队目前专注于Lerodalcibep在美国区域的上市准备工作。全球PCSK9市场规模正处在快速增长阶段，预计在2025年达到50亿美元，在2030年达到100亿美元，而Lerodalcibep有望成为其中一员。 Lerodalcibep BLA由一项2,900名患者的开发计划支持，其中包括五项全球III期注册研究，统称为“LIBerate”。这些研究包括2,300多名使用最大耐受他汀类药物和其他口服药物并需要进一步降低低密度脂蛋白胆固醇的患者。LIBerate III期研究评估了Lerodalcibep在心血管疾病（CVD）或其极高危或高危患者（包括HeFH和HoFH患者）中的安全性和有效性。在这些关键的注册、双盲、安慰剂对照试验中，Lerodalcibep每月给药一次，疗程长达52周。目前已有2,400多名患者继续参加了为期 72 周的开放标签扩展试验。新型第三代PCSK9抑制剂Lerodalcibep（HST101）是海森生物于2023年9月引入的首个在研创新药，与现有7款经典原研药协同加强了其在慢性病和急重症领域的产品布局。2024年11月，Lerodalcibep在海森生物全力推进下完成了国内III期临床试验首例受试者入组给药，标志着其在心血管及代谢疾病领域取得了里程碑式的进展。注：本文涉及研究中的药品尚未在中国获批，海森生物不推荐任何未被批准的药品使用。关于Lerodalcibep Lerodalcibep是一种基于Adnectin设计的分子量较小的融合蛋白，是新型第三代PCSK9抑制剂，已被开发为一种每月一次、注射容积小、每次仅需一针皮下注射、居家或旅行时方便携带、无需冷藏的更方便患者使用的药物。这些特点使Lerodalcibep有望成为已获批准的 PCSK9 抑制剂中独特的替代品。Lerodalcibep的抗PCSK9结合域是一个分子量仅为 11 kDa 称为adnectin的多肽，能与人类的PCSK９高度亲和，其亲和力达到亚纳摩尔级，并且与人血清白蛋白融合，以延长血浆半衰期。在FDA BLA备案后，LIB预计将于2025年第二季度向欧洲药品管理局（EMA）提交上市许可申请。关于 LIB Therapeutics Inc. LIB Therapeutics是一家私人控股的后期生物制药公司，致力于将Lerodalcibep提供给数百万心血管疾病患者和全球3,000万家族性高胆固醇血症（FH）患者。尽管他汀类药物和其他降脂药物已达到最大耐受量，但这些患者仍需要额外大幅降低低密度脂蛋白胆固醇（LDL-C），以达到 LDL-C 目标。关于海森生物医药有限公司海森生物医药有限公司（简称：海森生物）是一家成立于2020年的创新型生物医药企业，业务聚焦于慢性病和急重症领域。秉承诚信、敏捷、创新和主人翁精神的核心价值观，海森生物致力于成为中国健康行业引领者，携手政府相关机构、医疗卫生专业人士及业界合作伙伴，提供优质产品和解决方案，造福更多患者，共创社会健康价值。审批号：NP-HST101-2025-02-02 往期精选海森生物合作伙伴LIB宣布向FDA递交Lerodalcibep用于治疗成人低密度脂蛋白胆固醇升高的生物制品许可申请海森生物 I 类创新药HST101 III期临床试验完成首例受试者入组给药！海森生物合作伙伴LIB在第92届EASC上宣布 Lerodalcibep两项III期LIBerate研究取得积极结果欢迎分享，喜欢也请点个“赞”和“在看”吧

临床3期申请上市引进/卖出

2025-02-12

·SYNAPSE

2025年2月12日全球新药进展早知道

1. 强生两款first in class双抗国内获批上市 2月11日，强生宣布锐珂（埃万妥单抗）和拓立珂（塔奎妥单抗）的上市申请均已获得国家药监局批准。前者是全球首款获批上市的EGFR/c-MET双抗，后者是首个获批的靶向GPRC5D的双特异性抗体药物。本次埃万妥单抗获批的适应症是：与卡铂和培美曲塞联合给药，用于经检测确认携带表皮生长因子受体（EGFR）20号外显子插入突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。而塔奎妥单抗获批的适应症是：单药适用于既往接受过至少三线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38抗体）的复发或难治性多发性骨髓瘤（RRMM）成人患者。 2. 默沙东抗生素复方国内获批上市 2月11日，NMPA官网显示，默沙东抗生素复方「注射用头孢洛生他唑巴坦钠」获批上市。该复方（研发代号：MK-7625A）于2014年12月首次在美国获批上市，商品名为Zerbaxa，用于联合甲硝唑治疗指定易感微生物引起的复杂性腹腔感染和复杂性尿路感染（包括肾盂肾炎）。后来，其适应症又扩大至医院获得性细菌性肺炎（HABP）和呼吸机相关性细菌性肺炎（VABP）。 3. 每月一次PCSK9抑制剂在美国申报上市 2月10日，LIB Therapeutics公司宣布，美国FDA已受理潜在“best-in-class”在研疗法lerodalcibep的生物制品许可申请（BLA），lerodalcibep旨在降低低密度脂蛋白胆固醇（LDL-C），用于治疗动脉粥样硬化性心血管疾病（ASCVD）患者，以及具有极高或高ASCVD风险或原发性高脂血症（包括杂合子和纯合子家族性高胆固醇血症，HeFH/HoFH）患者。FDA预计在今年12月12日之前完成审评。Lerodalcibep是一种与PCSK9结合的创新第三代抑制剂，具有长期常温稳定性，开发目的是为患者提供一种更便捷、每月一次、可自行皮下注射的治疗方案。Lerodalcibep是一种小结合蛋白（SBP），其PCSK9靶向结合域为一种经过工程化设计的多肽，能够以亚纳摩尔级别的高亲和力与人类PCSK9蛋白结合。 4. 美泊利珠单抗在国内申报第4项新适应症 2 月 11 日，CDE 官网显示，GSK 美泊利珠单抗（Mepolizumab，Nucala）新适应症上市申请获受理。根据临床试验进展，该适应症可能为慢性阻塞性肺疾病（COPD）。这是美泊利珠单抗第 4 项在中国申报上市的适应症。美泊利珠单抗是一种特异性靶向白细胞介素 5（IL-5）的单克隆抗体，2015 年 11 月率先获 FDA 批准上市，成为全球首款获批的 IL-5 靶向单抗。而在中国，美泊利珠单抗已有 3 项适应症获批上市，分别为变应性肉芽肿血管炎、嗜酸性粒细胞哮喘和慢性鼻窦炎伴鼻息肉病。 5. 勃林格殷格翰PDE4B抑制剂第2项III期临床成功，拟申报上市 2月10日，勃林格殷格翰宣布其研发的口服、选择性磷酸二酯酶 4B（PDE4B）抑制剂Nerandomilast治疗特发性肺纤维化的第二项三期临床FIBRONEER-ILD试验中，成功达到主要终点。基于这些结果，该公司计划向美国FDA和全球其它监管机构提交nerandomilast治疗渐进性肺纤维化（PPF）的新药申请。Nerandomilast的临床开发计划包括两项3期研究——针对特发性肺纤维化（IPF）患者的FIBRONEER-IPF试验以及针对渐进性肺纤维化患者的FIBRONEER-ILD试验。去年9月，勃林格殷格翰宣布nerandomilast已经在治疗IPF的3期临床试验FIBRONEER-IPF中达到主要终点，显著改善IPF患者的肺功能。 6. 科伦博泰TROP2 ADC尿路上皮癌获得优异疗效 2月13-15日，2025年ASCO GU将在旧金山召开，科伦博泰芦康沙妥珠单抗（研发代码SKB264、MK-2870）单药治疗晚期尿路上皮癌1/2期临床数据将于2025年2月11日06:00在“Poster Session B：Urothelial Carcinoma”上以海报形式报告。此次科伦博泰公布的TROP2 ADC芦康沙妥珠单抗单药治疗使用过含铂化疗及PD-(L)1免疫治疗的后线转移性尿路上皮癌患者的疗效数据媲美Padcev用于同线次患者的疗效，并显著优于化疗的治疗效果。有望为晚期尿路上皮癌患者带来全新的治疗选择。默沙东正在开展PD-1+芦康沙妥珠单抗联合治疗转移性尿路上皮癌的二期临床试验。此外，默沙东还在开展PD-1+Padcev+芦康沙妥珠单联合治疗尿路上皮癌的1/2期临床试验。两款ADC靶点不同，payload杀伤机制也不同，分别为微管抑制剂MMAE和TOPO1抑制剂，两者联用有望发挥更好的协同抗肿瘤效应。 1. 礼来一天达成两项重磅交易，押注核药、RNAi 2月10日，礼来宣布了两项重要合作，分别与Advancell（核药公司）、OliX Pharmaceuticals（RNAi疗法公司）合作，进一步加大在这两大领域的投资。礼来与Advancell的合作中，双方将利用AdvanCell专有的Pb-212生产技术和放射性核素开发基础设施、礼来公司的候选药物计划以及药物开发方面的广泛专业知识，促进靶向α疗法扩大组合的开发和加速临床进展。礼来与OliX Pharmaceuticals的合作重点是OLX75016的开发和商业化，OLX75016是一种主要针对MASH和其他心脏代谢适应症的I期RNAi药物。OliX Pharmaceuticals将收到礼来的首期付款，以完成目前正在澳大利亚进行的I期临床试验。 2. 超30亿美元！诺华收购一款心血管重磅新药 2月11日，跨国药企巨头诺华宣布收购波士顿临床阶段生物制药公司Anthos Therapeutics，该公司拥有一款正在开发的，用于预防心房颤动患者中风和全身栓塞的晚期药物abelacimab（阿贝拉昔单抗）。该交易预计将于2025年上半年完成，诺华将交易完成后支付9.25亿美元的预付款，并在达到规定的监管和销售里程碑后可能额外支付高达21.5亿美元。内容来源于网络，如有侵权，请联系删除。

上市批准临床结果Best in Class抗体药物偶联物核酸药物

2025-02-10

·药明康德

每月一次！超90%患者胆固醇水平达标，潜在“best-in-class”疗法有望今年获批

▎药明康德内容团队编辑 LIB Therapeutics公司今天宣布，美国FDA已受理潜在“best-in-class”在研疗法lerodalcibep的生物制品许可申请（BLA），lerodalcibep旨在降低低密度脂蛋白胆固醇（LDL-C），用于治疗动脉粥样硬化性心血管疾病（ASCVD）患者，以及具有极高或高ASCVD风险或原发性高脂血症（包括杂合子和纯合子家族性高胆固醇血症，HeFH/HoFH）患者。FDA预计在今年12月12日之前完成审评。 Lerodalcibep是一种与PCSK9结合的创新第三代抑制剂，具有长期常温稳定性，开发目的是为患者提供一种更便捷、每月一次、可自行皮下注射的治疗方案。Lerodalcibep是一种小结合蛋白（SBP），其PCSK9靶向结合域为一种经过工程化设计的多肽，能够以亚纳摩尔级别的高亲和力与人类PCSK9蛋白结合。此外，通过与人血清白蛋白（HSA）的融合，lerodalcibep显著延长其血浆半衰期，可达12-15天。 Lerodalcibep的BLA申请得到了一项包含2900名患者的开发计划（名为LIBerate）的支持，其中包括五项全球性3期注册性研究。这些研究中包含了超过2300名在最大耐受剂量的他汀类及其他口服药物治疗下仍需要进一步降低LDL-C的患者。LIBerate研究评估了lerodalcibep在心血管疾病（CVD）患者或具有极高及高CVD风险患者中的安全性和有效性，包括HeFH和HoFH患者。在这些关键性注册研究中，患者接受每月一次lerodalcibep的治疗，最长治疗时间为52周。此外，超过2400名患者继续参与为期72周的开放标签扩展试验（OLE）。此前公布的开放标签扩展研究的数据显示：在开放标签扩展研究的额外72周治疗期间，与基线相比，患者LDL-C水平的降低幅度始终超过60%（P<0.0001），且无减弱趋势，包括那些接受lerodalcibep治疗超过2年的患者。超过90%的患者实现了LDL-C从基线减少≥50%的目标，并达到新的更低LDL-C水平目标值，即<55 mg/dL，包含那些患有CVD或具有极高CVD风险的患者。 ▲不同患者亚群达成目标LDL-C水平的比例（图片来源：参考资料[2]） ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population. Retrieved February 10, 2025, from https://www.businesswire.com/news/home/20250210806330/en [2] Phase 3 LIBerate OLE for CVD and HR/VHR CVD - AHA 2024. Retrieved Decembe 16, 2024，from https://cdn.prod.website-files.com/61e62faab82c326a4b4e92af/673bd01567492472b917a4ad_AHA%202024%20LIBerate-OLE%20CVD%20VHR%20or%20HR%20study.pdf 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

AHA会议临床结果临床3期

100 项与莱达西贝普相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
动脉粥样硬化	申请上市	美国	LIB Therapeutics LLC	2024-12-16
杂合子家族性高胆固醇血症	申请上市	美国	LIB Therapeutics LLC	2024-12-16
纯合子家族性高胆固醇血症	申请上市	美国	LIB Therapeutics LLC	2024-12-16
原发性高脂血症	申请上市	美国	LIB Therapeutics LLC	2024-12-16
动脉硬化	临床3期	挪威	LIB Therapeutics LLC	2020-12-03
动脉硬化	临床3期	印度	LIB Therapeutics LLC	2020-12-03
动脉硬化	临床3期	土耳其	LIB Therapeutics LLC	2020-12-03
动脉硬化	临床3期	南非	LIB Therapeutics LLC	2020-12-03
动脉硬化	临床3期	以色列	LIB Therapeutics LLC	2020-12-03
II型高脂蛋白血症	临床3期	印度	LIB Therapeutics LLC	2020-12-03

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04798430 (LIBerate-OLE, Biospace) 人工标引	临床3期	心血管疾病 \| 纯合子家族性高胆固醇血症 \| 杂合子家族性高胆固醇血症 \| 高胆固醇血症	1,468	Lerodalcibep	(窪鹽鑰鑰繭餘衊醖蓋願) = 繭窪膚鑰築憲膚蓋糧簾衊繭鑰觸範糧餘鹹艱願 (膚鹽構憲簾鬱簾餘選齋 ) 更多	积极	2024-12-18
NCT04797247 (LIBerate-CVD, BusinessWire) 人工标引	临床3期	动脉粥样硬化	922	Lerodalcibep	(鑰觸構製觸製壓鬱構鹹) = 鹹廠顧憲鬱廠鑰製鹽襯齋範憲願窪網網築範壓 (簾顧齋鑰築憲壓遞構淵 ) 达到更多	积极	2024-05-29
				Placebo	(鬱鑰淵夢製繭鏇蓋襯憲) = 構遞憲鹹襯窪齋窪選夢衊鹽範遞膚築鹹艱鹹齋 (餘範積鏇憲鬱遞夢遞構 )
NCT05004675 (LIBerate-VI, BusinessWire) 人工标引	临床3期	动脉粥样硬化	166	Lerodalcibep 300 mg monthly	(遞艱製憲網膚蓋遞糧積) = 繭鹽範窪糧膚顧糧網廠艱廠鏇觸願襯窪製鏇選 (糧蓋壓網鑰廠鹽顧築積 ) 更多	积极	2024-05-29
				Inclisiran 284 mg on Day 1 and 90	(遞艱製憲網膚蓋遞糧積) = 鬱觸築獵獵廠製願願廠艱廠鏇觸願襯窪製鏇選 (糧蓋壓網鑰廠鹽顧築積 ) 更多
NCT04806893 (LIBerate-HeFH, Biospace) 人工标引	临床3期	心血管疾病 PCSK9	922	Lerodalcibep 300 mg	(蓋願蓋顧積衊顧鹹積襯) = 遞廠衊製觸艱繭鹹鏇淵夢構鑰觸壓觸憲窪窪鏇 (鹽蓋襯廠構遞鑰蓋鏇齋 ) 达到更多	积极	2024-04-08
NCT04798430 (LIBerate-OLE, Biospace) 人工标引	临床3期	心血管疾病	421	Lerodalcibep	(憲鏇構選製網壓築夢糧) = 鑰網襯願醖遞範淵醖築網醖網衊遞艱膚憲齋夢 (獵積鹹襯窪餘鏇鏇憲範 )	积极	2024-04-07
NCT04797104 (LIBerate-FH, Literature) 人工标引	临床3期	杂合子家族性高胆固醇血症	478	Lerodalcibep	(築膚遞積顧鹽壓膚餘鹹) = 膚製構獵鹽獵膚鑰製齋繭遞鬱簾構繭顧廠醖糧 (選鬱鏇鹹齋獵壓築願觸 ) 更多	积极	2023-08-28
				placebo	(築膚遞積顧鹽壓膚餘鹹) = 積網夢艱築獵鹽選壓壓繭遞鬱簾構繭顧廠醖糧 (選鬱鏇鹹齋獵壓築願觸 ) 更多
NCT03847974 (AHA2019) 人工标引	临床2期	高胆固醇血症	32	LIB003	(淵齋壓鏇鏇繭鹽鏇範選) = LIB was well tolerated with all AEs considered mild and not drug related. Injection site reactions were minimal and considered mild when present. 鹹壓築積積蓋繭鹽餘顧 (選範範壓鬱網繭範鑰網 ) 更多	积极	2019-11-11
				Placebo