The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

开始日期2024-06-25

申办/合作机构

Novo Nordisk A/S

[+1]

NCT06263244 / Not yet recruiting临床3期IIT

Specifying the Anti-inflammatory Effects of Ziltivekimab With Diverse Imaging Modalities and In-depth Cellular Phenotyping

The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics.

开始日期2024-04-01

申办/合作机构-

NCT06200207 / Recruiting临床3期

Effects of Ziltivekimab Versus Placebo on Heart Failure Symptoms and Physical Function in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation

The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.

开始日期2024-04-01

申办/合作机构

Novo Nordisk A/S

100 项与 Ziltivekimab 相关的临床结果

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100 项与 Ziltivekimab 相关的转化医学

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100 项与 Ziltivekimab 相关的专利（医药）

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项与 Ziltivekimab 相关的文献（医药）

2024-01-01·Journal of the American Society of Nephrology : JASN

Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3–5: An Analysis of a Randomized Trial (RESCUE)

Article

作者: Pergola, Pablo E ; Davidson, Michael ; Andreas Schytz, Philip ; Perkovic, Vlado ; Mohseni Zonoozi, Amir A ; Raj, Dominic S ; Jensen, Camilla ; Tuttle, Katherine R

Significance Statement:

Systemic inflammation in CKD can lead to anemia. Ziltivekimab, a fully human monoclonal antibody targeting the IL-6 ligand, has been shown to reduce systemic inflammation in patients with CKD. It has also been shown to increase serum albumin in patients on hemodialysis with inflammation and hyporesponsiveness to treatment with erythropoiesis-stimulating agents. This exploratory analysis of the RESCUE clinical trial found that among patients with CKD stage 3–5 and systemic inflammation, ziltivekimab treatment significantly increased hemoglobin (Hb) levels after 12 weeks compared with placebo. Ziltivekimab was also associated with significant increases in serum iron levels, total iron-binding capacity, and transferrin saturation. No major safety concerns were reported. Further clinical trials are warranted to study ziltivekimab's potential for anemia management in patients with CKD.

Background:

In the phase 2 RESCUE clinical trial, ziltivekimab, a fully human monoclonal antibody against the IL-6 ligand, significantly reduced the biomarkers of inflammation compared with placebo, in patients with CKD and systemic inflammation (high-sensitivity C-reactive protein ≥2 mg/L). The aim of this subanalysis of RESCUE trial data was to assess the effect of ziltivekimab on Hb and iron homeostasis in this patient population.

Methods:

This was an analysis of exploratory end points from the RESCUE trial (NCT03926117), which included 264 adults with CKD stage 3–5 and high-sensitivity C-reactive protein ≥2 mg/L. Participants received placebo or subcutaneous ziltivekimab (7.5, 15, or 30 mg) (1:1:1:1) once every 4 weeks, up to 24 weeks. End points for this analysis were changes in Hb and biomarkers of iron homeostasis from baseline to week 12.

Results:

The trial was terminated early due to the coronavirus disease 2019 pandemic, and thus, data up to week 12 are presented. Hb levels significantly increased from baseline to week 12 with ziltivekimab 7.5, 15, and 30 mg (treatment differences versus placebo: +0.57 g/dl [95% confidence interval, 0.27 to 0.86], +1.05 g/dl [0.76 to 1.33], and +0.99 g/dl [0.70 to 1.28], respectively, all P < 0.001). Ziltivekimab was associated with significant increases in serum iron levels, total iron-binding capacity, and transferrin saturation from baseline to week 12 (P < 0.05 versus placebo for all doses and comparisons). Cases of sustained thrombocytopenia, sustained neutropenia, anemia, and iron deficiency anemia were infrequent and similar across all groups.

Conclusions:

Anti-inflammatory therapy with ziltivekimab improved the markers of anemia and iron homeostasis in people with stage 3–5 CKD and systemic inflammation, suggesting a possible role in anemia management.

2023-11-01·Clinical therapeutics

An Update on Inflammation in Atherosclerosis: How to Effectively Treat Residual Risk

Review

作者: El Messaoudi, S ; Opstal, T S J ; Cornel, J H ; Bax, W A ; Mohammadnia, N

PURPOSE:

This study reviewed the contribution of inflammation to atherosclerotic cardiovascular disease (ASCVD), which has gained widespread recognition in recent years.

METHODS:

This critical review evaluated how recent publications and ongoing clinical trials in atherosclerotic inflammation will affect clinical care.

FINDINGS:

Key trials, including CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcomes Study) with canakinumab (interleukin-1β inhibition), and COLCOT (Colchicine Cardiovascular Outcomes Trial) and LoDoCo2 (Low Dose Colchicine 2) with colchicine, have shown that suppressing inflammation can improve outcomes in ASCVD. Cholesterol crystals play an important role in activating the NOD-, LRR-, and pyrin domain-containing protein 3 inflammasome and subsequent cytokine cascade. Inflammation contributes to significant residual risk after optimal lipid-lowering therapy. High-sensitivity C-reactive protein is a recognized biomarker of residual risk, and newer biomarkers such as the neutrophil to lymphocyte ratio may add additional information. The role of lipoprotein(a) as a proinflammatory agent or possible inflammatory biomarker is under investigation. The contribution of clonal hematopoiesis of indeterminate potential and trained immunity are in the early stages of investigation. Ongoing clinical trials of suppressing inflammation with NOD-, LRR-, and pyrin domain-containing protein 3 inflammasome inhibition (colchicine) and alternative approaches with downstream interleukin-6 ligand inhibition (ziltivekimab) will expand the evidence base for the use of anti-inflammatory agents in ASCVD.

IMPLICATIONS:

Based on current evidence and ongoing clinical trials, targeting inflammation alongside optimal lipid lowering is likely to be central to the future treatment of ASCVD. (Clin Ther. 2023;45:XXX-XXX) © 2023 Elsevier HS Journals, Inc.

2023-10-01·Journal of cardiology

Efficacy and safety of interleukin-6 inhibition with ziltivekimab in patients at high risk of atherosclerotic events in Japan (RESCUE-2): A randomized, double-blind, placebo-controlled, phase 2 trial.

Article

作者: Wada, Yukihiro ; Honda, Hirokazu ; Zonoozi, Amir Abbas Mohseni ; Meyer, Anna Sina Pettersson ; Jensen, Camilla

BACKGROUND:

Despite optimal treatment, a residual inflammatory risk often remains in patients with atherosclerotic cardiovascular disease. In a US-based phase 2 trial, ziltivekimab, a fully human monoclonal antibody targeting the interleukin-6 ligand, significantly reduced biomarkers of inflammation compared with placebo in patients at high atherosclerotic risk. Here, we report the efficacy and safety of ziltivekimab in Japanese patients.

METHODS:

RESCUE-2 was a randomized, double-blind, 12-week, phase 2 trial. Participants aged ≥20 years with stage 3-5 non-dialysis-dependent chronic kidney disease and high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L were randomized to receive placebo (n = 13) or subcutaneous ziltivekimab 15 mg (n = 11) or 30 mg (n = 12) at Weeks 0, 4, and 8. The primary endpoint was percentage change in hsCRP levels from baseline to end of treatment (EOT; mean of Week 10 and Week 12 values).

RESULTS:

At EOT, median hsCRP levels were reduced by 96.2 % in the 15 mg group (p < 0.0001 versus placebo), by 93.4 % in the 30 mg group (p = 0.002 versus placebo), and by 27.0 % in the placebo group. Serum amyloid A and fibrinogen levels were also reduced significantly. Ziltivekimab was well tolerated and did not affect total cholesterol to high-density lipoprotein cholesterol ratios. There was a small, but statistically significant increase in triglyceride levels with ziltivekimab 15 mg and 30 mg compared with placebo.

CONCLUSIONS:

The efficacy and safety results support the development of ziltivekimab for secondary prevention and the treatment of patients at high atherosclerotic risk.

CLINICALTRIALS:

gov identifier, NCT04626505.

项与 Ziltivekimab 相关的新闻（医药）

2024-06-28

·CPHI制药在线

再生元/赛诺菲IL-6受体拮抗剂再获FDA批准新适应症，靶向IL-6疗法潜力持续释放

关注并星标CPHI制药在线近日，FDA批准再生元（Regeneron Pharmaceuticals）和赛诺菲（Sanofi）共同开发的Kevzara（sarilumab），用于治疗体重63公斤或以上的活动性多关节型幼年特发性关节炎（pJIA）患者，这是一种同时影响多个关节的关节炎。美国FDA批准该疗法用于治疗pJIA患者群体是基于充分且具有良好对照的试验结果、来自类风湿性关节炎成年患者的药代动力学数据，以及针对pJIA儿童患者的药代动力学、药效学、剂量探索和安全性研究。 Kevzara是再生元与赛诺菲共同开发的人源化单抗药物，它能结合白细胞介素-6（IL-6）受体，从而抑制由它介导的信号通路。在人体中，白细胞介素-6是一种在炎症反应中扮演了重要作用的细胞因子。当它的表达量长期高于正常水平时，就会造成一系列炎症反应，其中就包括了与类风湿性关节炎有关的炎症。除了pJIA，Kevzara目前已在25个国家或地区获批用于治疗中度至重度活动性类风湿性关节炎成人患者。Kevzara还获FDA批准用于治疗风湿性多肌痛（一种炎症性风湿性疾病），用于治疗对皮质类固醇反应不足或不能耐受皮质类固醇逐渐减量的成年患者。 IL-6简介及信号通路 IL-6属于白细胞介素的一种，是一种多功能细胞因子，参与多种细胞的生长、分化和功能调节，在免疫和炎症反应中具有重要作用，是机体重要的免疫-神经-内分泌调节因子。IL-6是小分子多肽，由四个α螺旋组成。分子量为19-28kD，具有184个氨基酸残基，通常情况下以单体形式存在，等电点为5.0，有糖基化位点，有两个二硫键。编码IL-6的基因位于染色体7p15-21，包括4个内含子与5个外显子。 IL-6的功能多样性主要在于和细胞表面多种IL-6受体的相互作用，然后经下游信号传导途径将多种生物信号传给不同的组织和细胞。IL-6分泌失调与多种疾病的病理生理过程密切相关。近年来研究发现，IL-6在许多炎症性疾病如类风湿性关节炎（RA）、系统性红斑狼疮（SLE）、克罗恩病（CD）等中高度表达，成骨细胞产生的IL-6能刺激破骨细胞的形成，并与多种细胞因子相联系参与炎症和发热反应，导致炎性疾病如类风湿性关节炎和强直性脊柱炎的发生。 IL-6作用模式主要包括经典信号途径（Classic Signaling）和转移信号途径（Trans-Signaling）。在经典途径中，IL-6与其膜结合受体mIL-6R、可溶性受体sIL-6R结合后，招募gp130（一种跨膜蛋白，细胞因子受体）结合形成IL-6-IL-6R-gp130六聚体，触发下游JAK-STAT、RAS-RAF等信号通路转导和基因表达。在转移信号途径中，IL-6-sIL-6R复合物与gp130结合，启动细胞内信号转导，促进细胞增殖、分化、氧化应激和免疫调节。 IL-6信号通路图片来源：参考来源1 全球四款药物获批上市目前，靶向IL-6通路的抗体药物已成为多种自身免疫病和癌症的创新疗法，并运用于细胞因子风暴等其他疾病。IL-6抑制剂可阻断IL-6与IL-6R结合，抑制IL-6的信号转导，从而减少病例炎症反应。据 Insight 数据库显示，目前全球已有四款IL-6/6R抑制剂获批，除了赛诺菲和再生元的Sarilumab外，还有罗氏的托珠单抗和萨特利珠单抗以及EUSA Pharma的司妥昔单抗。除Sarilumab外，其余三款目前均已在国内上市。图片来源：肖恩记药托珠单抗：托珠单抗最初由Chugai研发，后与罗氏共同开发和销售的可以结合sIL-6R和mIL-6R的单抗药物，先后于2005年、2009年、2010年和2013年在日本、欧盟、美国和中国获批上市，用于治疗类风湿关节炎（RA）、全身型幼年特发性关节炎(sJIA)和细胞因子释放综合征(CRS)等。目前，全球已有三款托珠单抗生物类似药获批上市，分别为Tyenne（Fresenius）、施瑞立（百奥泰/渤健）和安维泰（丽珠医药）。其中，施瑞立是唯一一款在中美均已获批上市的托珠单抗生物类似药。另外，还有三款托珠单抗生物类似药也已提交上市申请，分别为CT-P47（Celltrion）、CMAB806（迈博太科）和HS628（博锐生物）。司妥昔单抗（Siltuximab）：司妥昔单抗是一款单克隆抗体，用于阻断在iMCD患者中检测到升高的多功能细胞因子白细胞介素-6（IL-6）的活动，最初由强生公司研发，后授权给EUSA Pharma公司。2020年1月，百济神州与EUSA Pharma达成合作，获得了在大中华地区开发和商业化包括司妥昔单抗在内两款药物的权利。多中心Castleman病是一种罕见、危及生命的衰竭性淋巴组织增生疾病，能够产生免疫细胞的异常增生，并在症状和组织学特征上与淋巴瘤有许多相似之处。患者有轻重不同的症状：有的只是单个淋巴结异常，伴有轻度流感一样的症状；严重的有全身许多淋巴结异常、血细胞数量异常、多个器官功能异常并危及生命。Sylvant也是FDA批准的首个MCD领域的药物。萨特利珠单抗（Satralizumab）：萨特利珠单抗是罗氏开发的一款全人源化的白细胞介素-6（IL-6）单抗药物，可以抑制IL-6信号通路，并且抑制炎症的产生。2021年5月，该药首次在中国获批上市，用于治疗水通道蛋白4（AQP4）抗体阳性的视神经脊髓炎谱系疾病（NMOSD）的12岁及以上青少年及成人患者。除了NMOSD，罗氏还在探索萨特利珠单抗用于其他适应症，针对全身型重症肌无力、自身免疫性脑炎（AIE）、髓鞘少突胶质细胞糖蛋白抗体相关疾病（MOGAD）、甲状腺相关眼病（TED）处于临床3期，针对肺动脉高压、面肩肱型肌营养不良症处于临床2期。 IL-6/6R拮抗剂全球研发进展除了上述上市的药物之外，目前全球约30个在研的IL-6/6R拮抗剂已进入临床或申报阶段，包括优时比的olokizumab、诺和诺德的ziltivekimab和罗氏的RG6179等已进入关键3期临床，其中olokizumab用于治疗RA疾病正在进行上市申请。国内方面伟德杰生物、嘉和生物也有相关产品进入临床阶段。从适应症布局来看，主要集中在类风湿关节炎（RA）、炎症性肠病(IBD)和系统性红斑狼疮（SLE）等常见的自身免疫性疾病，此外在眼科的糖尿病性黄斑水肿(DME)和心血管疾病动脉粥样硬化等领域也有涉及。全球部分在研IL-6/6R拮抗剂图片来源：写同意Biotech Olokizumab Olokizumab最初由优时比公司研发，是一款靶向IL-6的人源化单抗。后来在2013年转让给了俄罗斯药企R-Pharm，目前正在进行RA领域的上市申请。Josef等人在新英格兰医学杂志上报道了Olokizumab的一项为期24周的3期多中心安慰剂和阳性对照试验中（NCT02760407），该试验招募了1648名对甲氨蝶呤无反应的类风湿性关节炎志愿者，该队列被分成四组：每两周一次的olokizumab单抗，每四周一次的olokizumab单抗，每两周一次的阿达木单抗，或安慰剂。在所有措施中，24周后，与安慰剂相比，两种剂量水平的olokizumab都明显有效。尽管发现olokizumab单抗比阿达木单抗略微有效，但研究人员认为这种增加在统计学上并不显著，不足以认为它具有优势。但是，它至少与阿达木单抗同样有效的事实意味着它应该是对目前可用的治疗方法没有反应的患者的一个有希望的新选择。 Ziltivekimab Ziltivekimab是一款人白细胞介素6（IL-6）单克隆抗体，最初由Corvidia Therapeutics研发。2020年6月，诺和诺德以21亿美元收购Corvidia Therapeutics，获得了其主要候选药物ziltivekimab的开发工作。Ziltivekimab通过阻断IL-6通路来降低全身炎症，从而降低动脉粥样硬化性心血管疾病（ASCVD）和慢性肾脏病（CKD）患者的主要心血管不良事件风险。在II期临床研究中，结果显示，ziltivekimab显著降低了与动脉粥样硬化相关的炎症和血栓形成的生物标志物，包括高敏C反应蛋白（hsCRP）等。Ziltivekimab目前正在进行3期试验，以验证其在不同心血管疾病人群中的获益。 RG6179 罗氏的RG6179是一款专门为眼内使用的抗IL-6单克隆抗体，特别的优化让它很容易被系统清除。在治疗葡萄膜炎性黄斑水肿（uveitic macular edema）患者的1期临床试验中，所有剂量的RG6179均改善患者视力且并未导致视网膜积水。大约25-30%的患者在接受治疗12周后的视力可以从视力表上多读15个字母。基于这些结果，目前RG6179正在3期临床试验中接受检验。结语白细胞介素-6（IL-6）是一种功能广泛的多功能细胞因子，具有调节免疫应答、急性期反应及造血功能，并在机体的抗感染免疫反应中发挥重要作用。IL-6作为自免领域靶点取得了很大的成功，目前国内外还有多家药企布局在IL-6/IL-6R拮抗剂，开拓新的适应症。靶向IL-6疗法究竟还有多少潜力待挖掘呢？让我们拭目以待。参考来源 1.Fernanda I Arnaldez,1 Steven J O'Day,2,3 Charles G Drake,4 Bernard A Fox,5 Bingqing Fu,6 Walter J Urba,5 Vincenzo Montesarchio,7 Jeffrey S Weber,8 Haiming Wei,6 Jon M Wigginton,9 Paolo Antonio Ascierto, The Society for Immunotherapy of Cancer perspective on regulation of interleukin-6 signaling in COVID-19- related systemic inflammatory response, J Immunother Cancer 2020;8:e000930. 2.Masashi Narazaki and Tadamitsu Kishimoto, The Two-Faced Cytokine IL-6 in Host Defense and Diseases, Int. J. Mol. Sci. 2018, 19, 3528. 3.Mansur Aliyu et.al, Interleukin-6 cytokine: An overview of the immune regulation, immune dysregulation, and therapeutic approach, International Immunopharmacology 111 (2022) 109130 4.Josef S. Smolen et.al, Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis, N Engl J Med 2022;387:715-26. 5.Paul M Ridker, Matt Devalaraja, Florian M M Baeres, Mads D M Engelmann, G Kees Hovingh, Milana Ivkovic, Larry Lo, Douglas Kling, Pablo Pergola, Dominic Raj, Peter Libby, Michael Davidson, IL-6 inhibition with ziltivekimab in patients at high atherosclerotic risk (RESCUE): a double-blind, randomised, placebo-controlled, phase 2 trial, Lancet 2021; 397: 2060–69 来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

2024-03-30

·药渡

从11亿美元交易，看诺和诺德在心衰领域布局

近日，诺和诺德（Novo Nordisk）宣布将以10.25亿欧元（约合11亿美元）的价格收购Cardior Pharmaceuticals（以下简称“Cardior”），加强自己在心血管疾病领域的研发管线。Cardior成立于2016年，是一家临床阶段生物制药公司，主要致力于RNA疗法的发现与开发，专注于针对心脏功能失调的根本原因，开发预防、修复和逆转心脏疾病的RNA疗法。通过此次收购，诺和诺德将获得Cardior用于治疗心衰的核心在研产品CDR132L。来源：globenewswire.com凭借司美格鲁肽这一现象级产品赚得盆满钵满的诺和诺德，已经开始在新的领域下注，尤其针对心血管疾病，诺和诺德旨在建立一个专注的、有影响力的治疗组合。透过此次并购，我们一窥诺和诺德在心血管治疗领域的布局。01CDR132L：可逆转心衰的ASO药物Cardior的CDR132L是一款靶向miR-132的特异性反义寡核苷酸（ASO）药物，可选择性阻断miR-132分子异常水平，从而停止并部分逆转细胞病理学，带来心脏功能的长期改善。miR-132是一种非编码RNA（ncRNA），当患者处于心肌细胞应激条件时，心脏miR-132表达上调，miR-132的高表达会导致进行性不良心脏重构，最终导致心衰（HF）发生。在Ib期临床试验中（n=28），结果显示，CDR132L具有良好的安全性、及耐受性，且血浆药代动力学曲线呈线性，没有积累的迹象。与安慰剂相比，CDR132L治疗后心力衰竭患者的心脏功能得到了改善。目前，CDR132L正在开展治疗心衰的II期临床（HF-REVERT）研究。除了CDR132L，Cardior管线内还有三款治疗肥厚性和扩张型心肌病等心脏疾病的疗法正在开发：CDR348T（ncRNA调节剂）、CDR641L（ncRNA干扰剂）以及一款尚未披露具体信息的处于安全性/毒理学研究阶段的项目，它们均是通过和ncRNA相互作用，起到治疗肥厚性心肌病等的作用。此次收购是诺和诺德布局心血管疾病领域的重要一步。02诺和诺德的心血管版图心脏疾病作为一种比较常见的循环系统疾病，其发展到末期的结果往往是心力衰竭（心衰），这会导致心肌无法泵出足够的血液来满足身体对血液和氧气的需求。心衰患者往往需要频繁住院，而且超过一半患者会在5年内死亡。据统计，全球有超过65万例心衰患者，最常见的诱发因素是缺血性心脏病、心肌病或高血压等。目前尚无相关治愈手段，仅有可以减缓症状的药物，但这些药物并不能阻止疾病进展。Cardior的管线产品则有望从根源上治愈心衰。由于心衰用药市场的巨大潜力，诺和诺德非常看好这一领域。近年来，其对心血管领域的布局一直在加大力度。司美格鲁肽司美格鲁肽作为一款现象级GLP-1产品，在降糖、减重领域批准上市后，诺和诺德就着手在心衰领域的适应症布局。在2023 年欧洲心脏病学会（ESC）年会上，诺和诺德发布了司美格鲁肽治疗射血分数保留的心力衰竭（HFpEF）的III期临床试验结果。在这项名为STEP HFpEF的临床试验中，结果显示，对于肥胖合并HFpEF患者，司美格鲁肽2.4 mg可有效减轻心衰症状和生活质量受限（以KCCQ-CSS 评分表示，评分越高，病症越轻）、改善运动功能（以6分钟步行距离表示）、减轻体重、改善炎症，同时具有良好的耐受性。具体来说，司美格鲁肽2.4mg组的KCCQ-CSS 评分提高了7.9分（16.6分 vs 8.7分，p＜0.001）；6分钟步行距离提高20.3米（21.5米 vs 1.2米，p＜0.001）。2024年3月9日，FDA批准了Wegovy（司美格鲁肽）的全新适应症——用于降低患有心血管疾病和肥胖或超重的成人心血管死亡、心脏病发作和中风的风险。IL-6抑制剂ZiltivekimabZiltivekimab是一款人白细胞介素6（IL-6）单克隆抗体，最初由Corvidia Therapeutics研发。2020年6月，诺和诺德以21亿美元收购Corvidia Therapeutics，获得了其主要候选药物ziltivekimab的开发工作。Ziltivekimab通过阻断IL-6通路来降低全身炎症，从而降低动脉粥样硬化性心血管疾病（ASCVD）和慢性肾脏病（CKD）患者的主要心血管不良事件风险。在II期临床研究中，结果显示，ziltivekimab显著降低了与动脉粥样硬化相关的炎症和血栓形成的生物标志物，包括高敏C反应蛋白（hsCRP）等。Ziltivekimab目前正在进行III期试验，以验证其在不同心血管疾病人群中的获益。细胞疗法HS-001在心衰治疗领域，诺和诺德还布局了细胞疗法。2021年，诺和诺德与Heartseed宣布，双方就后者HS-001干细胞疗法达成了全球独家合作和许可协议，交易总额达5.98亿美元。HS-001作为一种细胞疗法，其从诱导多能干细胞(iPSC)中提取纯化的心肌细胞，用于治疗心衰，目前正在进行I/II期临床研究，旨在评估HS-001在治疗缺血性心脏病引起的心力衰竭方面的安全性和有效性。2023年9月，诺和诺德与德国公司Evotec合作推出LAB eN²，瞄准心脏代谢疾病领域。2023年10月，诺和诺德宣布将以13亿美元从亨利医药收购Ocedurenone。该药是一款新型非甾体类选择性盐皮质激素受体拮抗剂（MRA），其通过选择性拮抗盐皮质激素受体，阻止醛固酮发挥作用，促进排尿，降低血压，被开发用来治疗高血压相关肾病，心力衰竭等。目前，该药已进行了9项临床试验。既往研究提示，Ocedurenone具有良好的疗效（降低血压）和耐受性（降低高钾血症风险）。诺和诺德打算在未来几年启动Ocedurenone在其他心血管和肾脏疾病适应症的III期试验，最大限度地发挥Ocedurenone的潜力。过去一年，诺和诺德还与AI药物开发公司Valo Health，达成一项总额达27亿美元的合作协议。双方将基于Valo Health的大型人类数据集和AI驱动的计算，发现和开发心脏代谢疾病的创新疗法。当下，诺和诺德以司美格鲁肽为核心，在建立更深护城河的同时，也拓展了更多适应症，心衰治疗是诺和诺德当下主要的战略方向。此次收购Cardior公司是诺和诺德在心血管疾病领域扩大业务范围和影响力的重要一步，使其获得了改善心力衰竭的变革性疗法。期待诺和诺德凭借其深厚的临床和商业化专业知识，围绕心血管疾病领域，早日获得积极结果。参考来源Novo Nordisk to acquire Cardior Pharmaceuticals and strengthen pipeline in cardiovascular disease.Clinical characteristics and 1-year outcomes in hospitalized patients with heart failure with preserved ejection fraction: results from the China Cardiovascular Association Database-Heart Failure Center Registry.射血分数保留的心力衰竭诊断与治疗中国专家共识2023. 中国循环杂志, 2023. 38(4): p. 375-393.Heartseed and Novo Nordisk enter into global collaboration and licence agreement for stem cell-based therapy for heart failure.2024FDA新药风云榜，获批拒绝结果汇总非阿片化长效改良来袭，镇痛新时代！MNC巨资追逐核药创新，国内企业加速抢滩点击“蓝字” 关注我们吧！

并购临床2期寡核苷酸

2024-03-25

·FierceBiotech

Novo Nordisk inks $1B Cardior buyout to pump up heart failure plans

Novo Nordisk moved to buy Cardior Pharmaceuticals after identifying CDR132L as a molecule with “a distinctive mode of action.” Novo Nordisk is pumping up its heart failure plans. The drugmaker, swelled by its GLP-1 windfall, has decided to buy Cardior Pharmaceuticals and its midphase prospect in a deal that could top out above 1 billion euros ($1.1 billion). Cardior is developing an antisense oligonucleotide to inhibit a piece of non-coding RNA, miR-132, that is implicated in heart failure. Upregulation of the RNA when certain cells are stressed can lead to changes in the size and shape of the heart. Blocking elevated miR-132 could therefore prevent or reverse changes that are associated with poor prognosis in patients who have heart attacks. The biotech raised 64 million euros from investors including Bristol Myers Squibb in 2021 and used the cash to take (PDF) its oligonucleotide, CDR132L, into a phase 2 trial the next year. Cardior has designed the 280-subject study to show CDR132L’s effect on the volume of blood in part of the heart. Cardior is still months away from the primary completion of the study, according to ClinicalTrials.gov, but Novo Nordisk is already planning to expand development. The Danish drugmaker plans to run another phase 2 trial in chronic heart failure patients with cardiac hypertrophy, a condition that negatively affects the heart’s ability to pump blood. CDR132L will slot into a pipeline that already features heart failure programs. Novo Nordisk reported clinical trial data on semaglutide, the active ingredient in Ozempic and Wegovy, in heart failure patients last year. The company is running a phase 3 trial of the IL-6 inhibitor ziltivekimab in a heart failure patient population and is working with Heartseed to test a cell therapy in an early-phase study. Novo Nordisk moved to buy Cardior after identifying CDR132L as a molecule with “a distinctive mode of action” that has the “potential to become a first-in-class therapy designed to halt or partially reverse the course of disease for people living with heart failure.” Advances in the treatment of heart failure have so far largely focused on managing the symptoms. CDR132L could address the underlying causes. The potential for CDR132L to provide long-lasting improvement in heart function led Novo Nordisk to put together an offer worth up to 1.025 billion euros for Cardior. The package includes an upfront payment and milestones, but neither party has provided a breakdown of the deal.

临床2期寡核苷酸临床3期细胞疗法

100 项与 Ziltivekimab 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性心肌梗塞	临床3期	美国	Novo Nordisk A/S	2024-06-25
急性心肌梗塞	临床3期	中国	Novo Nordisk A/S	2024-06-25
急性心肌梗塞	临床3期	日本	Novo Nordisk A/S	2024-06-25
急性心肌梗塞	临床3期	阿根廷	Novo Nordisk A/S	2024-06-25
急性心肌梗塞	临床3期	澳大利亚	Novo Nordisk A/S	2024-06-25
急性心肌梗塞	临床3期	巴西	Novo Nordisk A/S	2024-06-25
急性心肌梗塞	临床3期	保加利亚	Novo Nordisk A/S	2024-06-25
急性心肌梗塞	临床3期	加拿大	Novo Nordisk A/S	2024-06-25
急性心肌梗塞	临床3期	捷克	Novo Nordisk A/S	2024-06-25
急性心肌梗塞	临床3期	丹麦	Novo Nordisk A/S	2024-06-25

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临床结果

适应症

分期

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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


NCT03926117 (RESCUE, Pubmed)	临床2期	慢性肾病 high-sensitivity C-reactive protein	264	Ziltivekimab 7.5 mg	餘窪鑰鏇鏇鑰壓範簾壓(鬱築廠觸淵窪醖窪鏇窪) = 網艱壓積醖衊餘鏇觸衊網積鹽鹹繭獵範餘製壓 (餘窪積餘夢積積築網淵 )	积极	2024-01-01
				Ziltivekimab 15 mg	餘窪鑰鏇鏇鑰壓範簾壓(鬱築廠觸淵窪醖窪鏇窪) = 積鬱餘構壓淵糧範鏇壓網積鹽鹹繭獵範餘製壓 (餘窪積餘夢積積築網淵 )
NCT03926117 (CTgov)	临床2期	慢性肾病 \| 炎症	264	Ziltivekimab (Placebo)	衊廠糧積淵繭鏇觸醖築(憲網築憲憲夢餘簾顧範) = 淵願壓繭構憲鏇鏇簾衊顧製遞築膚簾顧鏇觸築 (選遞糧獵襯醖簾遞顧襯, 鑰鏇鑰蓋鏇齋繭窪鑰憲 ~ 鬱鬱獵壓夢夢膚網範願) 更多	-	2023-08-09
				Ziltivekimab (Ziltivekimab 7.5 mg)	衊廠糧積淵繭鏇觸醖築(憲網築憲憲夢餘簾顧範) = 網衊壓積襯壓糧範衊製顧製遞築膚簾顧鏇觸築 (選遞糧獵襯醖簾遞顧襯, 繭築餘憲艱淵憲遞艱簾 ~ 鑰夢鏇遞夢築鏇蓋繭網) 更多
NCT03926117 (RESCUE Trial, ASN2021)	临床2期	慢性肾病 serum hemoglobin \| iron homeostasis \| high-sensitivity C-reactive protein	-	Ziltivekimab 7.5 mg	繭繭餘糧餘構衊鹹襯鹽(製憲築壓齋廠醖廠製繭) = 鬱選網鹹繭夢蓋糧齋醖願齋膚鑰醖夢製範糧艱 (壓齋構淵鏇顧齋鹽餘蓋 )	积极	2021-10-27
				Ziltivekimab 15 mg	繭繭餘糧餘構衊鹹襯鹽(製憲築壓齋廠醖廠製繭) = 積夢艱鬱構餘遞範構顧願齋膚鑰醖夢製範糧艱 (壓齋構淵鏇顧齋鹽餘蓋 )
NCT02868229 (CTgov)	临床1/2期	贫血	61	Placebo (Placebo)	製築觸鬱顧繭製夢窪鑰(壓製鏇壓鏇廠淵構憲鏇) = 選艱鹽願鬱獵鏇廠築積廠壓鏇遞築憲餘淵餘壓 (襯鏇糧襯繭鹽糧窪襯壓, 遞夢壓選餘構膚膚鹽選 ~ 廠鹹顧鑰憲繭膚鏇醖鬱) 更多	-	2021-07-30
				COR-001 (COR-001)	夢艱繭簾蓋築鏇憲製獵(範蓋憲糧簾蓋鹽憲鑰窪) = 鬱鹽範醖製範鹹廠膚糧夢鑰顧衊鹽膚繭鹹廠積 (餘餘糧網襯簾簾夢醖淵, 觸製蓋壓築襯積鑰積選 ~ 齋網廠範艱廠繭鑰鹹鏇)