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. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. 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.

Start Date25 Jun 2024

Sponsor / Collaborator

Novo Nordisk A/S

[+1]

NCT06200207

/ RecruitingPhase 3

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.

Start Date01 Apr 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT06263244

/ Not yet recruitingPhase 3IIT

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.

Start Date01 Apr 2024

Sponsor / Collaborator-

100 Clinical Results associated with Ziltivekimab

100 Translational Medicine associated with Ziltivekimab

100 Patents (Medical) associated with Ziltivekimab

Literatures (Medical) associated with Ziltivekimab

01 Aug 2025·ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY

Direct Interleukin-6 Inhibition Blunts Arterial Thrombosis by Reducing Collagen-Mediated Platelet Activation

Article

Author: Beer, Jürg H. ; Liberale, Luca ; Montecucco, Fabrizio ; Unkelbach, Leonhard Paul ; Ministrini, Stefano ; Lüscher, Thomas F. ; Niederberger, Rebecca ; Kirmes, Kilian ; Han, Jiaying ; Camici, Giovanni G. ; Tirandi, Amedeo ; Bengs, Susan ; Bongiovanni, Dario ; Puspitasari, Yustina M. ; Libby, Peter

BACKGROUND::

Recent clinical trials demonstrated a reduction in biomarkers of thrombosis and inflammation in patients with very high cardiovascular risk treated with the anti–IL-6 (interleukin 6) monoclonal antibody ziltivekimab. However, if and how direct IL-6 inhibition exerts antithrombotic effects remains unknown. This translational project aimed to investigate the effect of direct IL-6 inhibition on experimental arterial thrombus formation and its underlying cellular mechanisms.

METHODS::

Three-month-old C57BL/6J male and female mice received very low dose lipopolysaccharide for 4 weeks; in addition to lipopolysaccharide, during the fourth week, mice were randomized to receive either anti-mouse IL-6 monoclonal antibody 200 μg or IgG1 isotype control. Thrombosis of the right common carotid artery was induced by endothelial-targeted laser injury. Coagulation factors and platelet reactivity were assessed in treated mice and controls. Platelets were isolated from whole blood and their reactivity to different chemical stimuli was measured by fluorescence-activated cell sorting. Additionally, whole blood samples from patients with a history of percutaneous coronary intervention were incubated ex vivo with either ziltivekimab biosimilar or IgG1 isotype control. Platelet reactivity at rest and in response to diverse chemical stimuli was quantified by fluorescence-activated cell sorting.

RESULTS::

Mice with low-grade chronic inflammation treated with anti–IL-6 monoclonal antibody displayed significantly blunted thrombus formation, without any significant difference in coagulation factors. Ex vivo stimulation with Collagen-rP (collagen-related peptide) significantly activated platelets isolated from control mice but not those obtained from mice treated with anti–IL-6 monoclonal antibody. Similarly, platelet reactivity from patients with previous percutaneous coronary intervention fell significantly after ex vivo treatment with ziltivekimab biosimilar.

CONCLUSIONS::

Direct IL-6 inhibition blunts thrombus formation by reducing collagen-induced platelet activation. These findings offer a potential mechanistic explanation for the results observed in the RESCUE trial and support the rationale of the ongoing ZEUS trial (Ziltivekimab Cardiovascular Outcome Study).

01 Dec 2024·Current Atherosclerosis Reports

“Anti-inflammatory Therapies in Atherosclerosis – Where are we going?”

Review

Author: Budoff, Matthew ; Kambalapalli, Soumya ; Iskander, Beshoy ; Roy, Sion K ; Krishnan, Srikanth ; Lakshmanan, Suvasini ; Ichikawa, Keishi ; Punnanithinont, Natdanai

PURPOSE OF REVIEW:

Inflammation has been commonly known for the past decade as a part of the pathophysiology of atherosclerosis, along with lipid accumulation. However, some patients with optimized lipid-lowering therapy still have elevated inflammatory biomarkers. Anti-inflammation therapies were developed to eradicate this residual risk. We summarized the primary inflammatory pathway and recent clinical trials in anti-inflammation therapies.

RECENT FINDINGS:

Colchicine Cardiovascular Outcomes Trial (COLCOT) and LoDoCo2 (Colchicine Reduces Risk of Major Cardiovascular Events in Chronic Coronary Disease) found that low-dose colchicine significantly reduced cardiovascular death, myocardial infarction (MI), ischemic stroke and coronary revascularization in patients with recent MI within 30 days and chronic coronary disease respectively. The US Food and Drug Administration approved low-dose colchicine in 2023 for patients with established atherosclerotic cardiovascular disease (ASCVD). However, its use was limited for chronic kidney disease (CKD) patients. Reduction in Inflammation in Patients with Advanced Chronic Renal Disease Utilizing Antibody Mediated Interleukin-6 Inhibition (RESCUE) was conducted using Ziltivekimab, an IL-6 ligand monoclonal antibody and found that it significantly reduced high-sensitivity C-reactive protein, an inflammatory surrogate marker. There is an ongoing phase-3 clinical trial, Ziltivekimab Versus Placebo Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease, and Systemic Inflammation trial (ZEUS), which will be essential for further anti-inflammation therapy for patients with CKD. Numerous clinical trials have investigated anti-inflammation therapies. Colchicine is by far the only one that has the potential to be widely used due to its cost-effectiveness. Further research is needed on other novel anti-inflammation therapies and their real-world implementation.

01 Jun 2024·Current opinion in lipidology

C-reactive protein, pharmacological treatments and diet: how to target your inflammatory burden

Review

Author: Bay, Benjamin ; Arnold, Natalie ; Waldeyer, Christoph

Purpose of review:

This article focuses on pharmacological agents as well as dietary changes aimed at the reduction of the inflammatory burden measured by circulating C-reactive protein concentrations.

Recent findings:

Over the last years, repurposed as well as new anti-inflammatory agents have been investigated in outcome trials in the cardiovascular field. Currently, a specific inhibition of the inflammatory cascade via the interleukin-6 ligand antibody ziltivekimab is being explored in large-scale outcome trials, after the efficacy of this agent with regard to the reduction of inflammatory biomarkers was proven recently. Next to the investigated pharmacological agents, specific dietary patterns possess the ability to improve the inflammatory burden. This enables patients themselves to unlock a potential health benefit ahead of the initiation of a specific medication targeting the inflammatory pathway.

Summary:

Both pharmacological agents as well as diet provide the opportunity to improve the inflammatory profile and thereby lower C-reactive protein concentrations. Whilst advances in the field of specific anti-inflammatory treatments have been made over the last years, their broad implementation is currently limited. Therefore, optimization of diet (and other lifestyle factors) could provide a cost effective and side-effect free intervention to target low-grade vascular inflammation.

News (Medical) associated with Ziltivekimab

20 May 2025

·firstwordpharma.com

Tourmaline plans CV outcomes study for quarterly dosed IL-6 inhibitor

Tourmaline Bio on Tuesday released the first results from a Phase II study of its long-acting anti-IL-6 monoclonal antibody pacibekitug, with the findings supporting quarterly dosing of the drug in a potential late-stage trial for atherosclerotic cardiovascular disease (ASCVD). "We are thrilled with the data…and the remarkable consistency of signal across all endpoints evaluated," remarked CEO Sandeep Kulkarni.However, Tourmaline's shares slipped around 4% on Tuesday, as investors digested the data in the context of the high placebo response and Novo Nordisk's similar IL-6 inhibitor ziltivekimab.The mid-stage TRANQUILITY study is evaluating quarterly and monthly subcutaneous dosing of pacibekitug in 143 patients with elevated high-sensitivity C-reactive protein (hs-CRP), a biomarker associated with elevated cardiovascular risk, and chronic kidney disease (CKD) stage 3 or 4. "All active arms achieved rapid, deep and durable reductions in hs-CRP, and overall incidence rates of adverse events and serious adverse events were comparable between pacibekitug and placebo," Kulkarni added.High placebo responseTop-line results showed that all doses of pacibekitug achieved the trial's primary endpoint of median time-averaged percent change in hs-CRP through day 90 with "high statistical significance" versus placebo. In participants that received Tourmaline's drug at a dose of 50 mg quarterly, the median time-averaged percent change in hs-CRP through day 90 was 86%, while it was 85% and 75% in the pacibekitug 15 mg monthly and 25 mg quarterly arms, respectively, compared to 15% for placebo. In Novo's mid-stage RESCUE trial, a monthly 30 mg dose of ziltivekimab led to a 92% mean reduction in levels of hsCRP after 12 weeks, compared to 4% for placebo.Tourmaline added that for TRANQUILITY's key secondary goal of the percentage of participants achieving time-averaged hs-CRP below 2 mg/L through day 90, the 15 mg monthly cohort came out on top, with a rate of 88%, compared to 26% for placebo. In the other two arms, the rates were 81% and 80%, respectively for pacibekitug 25 mg quarterly and 50 mg quarterly.Hopes on quarterly dosing"This is the first time that pacibekitug or any IL-6 inhibitor has been tested in a clinical trial with quarterly dosing," noted Kulkarni, something he suggested "has the potential to enhance patient adherence and ultimate clinical benefit."Tourmaline indicated that the cumulative incidence of any serious adverse event (AE) was 10% in the pooled pacibekitug group, compared with 11% in the placebo arm. While rates of serious infection were also similar between pacibekitug and placbo, all four cases associated with the drug occurred in the 25 mg quarterly dosing group, where there was also one death from COVID-19."Given the strength of the data, we look forward to accelerating development of pacibekitug within atherosclerotic cardiovascular disease and abdominal aortic aneurysm," Kulkarni said. Tourmaline indicated that it expects to provide further information on a potential Phase III cardiovascular outcomes trial in ASCVD later in 2025, while initiating a proof-of-concept study in patients with abdominal aortic aneurysm in the second half.

Clinical ResultPhase 2AHA

22 Jan 2025

·www.prnewswire.com

Chronic Heart Failure Market to Observe Stunning Growth at a CAGR of 10% by 2034 Owing to Strong Uptake of Entresto and approved SGLT2 Inhibitors along with Emergence of New Class of Therapies | DelveInsight

Several leading classes of therapies are exploring diverse mechanisms of action to treat CHF, including SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and more. This growing focus is expected to drive the chronic heart failure market forward. In summary, the existing blockbuster therapies such as Entresto, recently approved SGLT2 inhibitors, and Soluble guanylate cyclase (sGC) stimulators, along with emerging cell therapies, peptides, monoclonal antibodies, and small molecules, together have the potential to drive the existing market along with securing a significant market share upon introduction of new entrants to the CHF treatment landscape. LAS VEGAS, Jan. 22, 2025 /PRNewswire/ -- DelveInsight's Chronic Heart Failure Market Insights report includes a comprehensive understanding of current treatment practices, chronic heart failure emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Chronic Heart Failure Market Report According to DelveInsight's analysis, the market size for chronic heart failure was found to be approximately USD 5.5 billion in the US in 2023. Among the 7MM, the US contributed the largest market share of the total CHF market size and will continue to experience a steep rise in the market size throughout the forecast period. As per DelveInsight's estimate, the total diagnosed prevalent cases of CHF in the 7MM were approximately 20 million in 2023. Heart failure with preserved ejection fraction (HFpEF) contributed to most of the cases. Within class-specific diagnosed prevalence of Heart failure, NYHA class II and class III contribute the maximum. Established chronic heart failure companies with approved therapies in the market are Novartis, Otsuka, Boehringer Ingelheim/Eli Lilly, Bayer/Merck, Amgen/Servier, scPharmaceuticals, and Lexicon Pharmaceuticals/Viatris. In addition, Daiichi Sankyo and American Regent are targeting adult patients with heart failure who are iron deficient. Among all the approved therapies, Novartis and Otsuka's Entresto, approved since 2015 in the US, is still the leading therapy generating more than USD 4 billion in the 7MM in 2023. Among, Eli Lilly's Jardiance and AstraZeneca's Farxiga, both SGLT2 inhibitors, Farxiga is the leading prescribed SGLT2 inhibitor globally by volume Leading chronic heart failure companies developing emerging therapies, such as Cytokinetics, Bayer, Eli Lilly, BioCardia, Mesoblast, Tenax Therapeutics, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Intra-Cellular Therapies, Cardurion Pharmaceuticals, Rivus Pharmaceuticals, and others are developing novel chronic heart failure drugs that can be available in the chronic heart failure market in the coming years. The promising chronic heart failure therapies in the pipeline include Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others. In October 2024, Viatris entered into an exclusive licensing agreement with Lexicon Pharmaceuticals for INPEFA (sotagliflozin) in all markets outside of the US and EU. In September 2024, Bayer presented the late-breaking data of Phase III FINE-HEART findings of KERENDIA (finerenone) during a Hot Line session at the European Society of Cardiology (ESC) Congress 2024. In May 2024, Eli Lilly and Company committed an additional USD 5.3 billion manufacturing investment in the company's newest Indiana site to boost API production for tirzepatide and pipeline medicines. AstraZeneca expects the data of the Phase III BalanceD-HF trial of balcinrenone (AZD9977) + dapagliflozin for heart failure in 2025. Discover which therapies are expected to grab the major chronic heart failure market share @ Chronic Heart Failure Market Report Chronic Heart Failure Overview Chronic heart failure is a long-term condition in which the heart's ability to pump blood efficiently is reduced, leading to inadequate circulation of oxygen and nutrients to meet the body's needs. The primary causes of CHF include coronary artery disease, high blood pressure, diabetes, cardiomyopathy, valvular heart disease, and previous heart attacks. Lifestyle factors like obesity, smoking, excessive alcohol consumption, and a sedentary lifestyle can also contribute to its development. The symptoms of CHF vary in severity and may include persistent fatigue, shortness of breath, swelling in the legs, ankles, or abdomen, rapid or irregular heartbeat, and difficulty exercising. Advanced cases can lead to severe fluid retention, wheezing, and an inability to carry out daily activities. Diagnosis typically involves a comprehensive medical history review and a physical examination, followed by tests like an ECG to assess heart rhythm, echocardiography to evaluate heart structure and function, blood tests, chest X-rays, and stress tests. Early diagnosis and management are crucial to improving quality of life and preventing complications. Chronic Heart Failure Epidemiology Segmentation The chronic heart failure epidemiology section provides insights into the historical and current chronic heart failure patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The chronic heart failure market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Heart Failure Gender-specific Cases of Heart Failure Ejection Fraction-specific Cases of Heart Failure New York Heart Association (NYHA) Class-specific Cases of Heart Failure Type-specific Cases of Heart Failure Age-specific Cases of Heart Failure Chronic Heart Failure Treatment Market Current treatments for heart failure primarily rely on angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and diuretics. Additional therapies, such as aldosterone antagonists, amiodarone, antiplatelets, anticoagulants, calcium channel blockers, and nitrates, are also utilized in managing the condition. Most treatment regimens involve a combination of therapies, with beta-blockers being among the most commonly prescribed. Among the approved treatments, Novartis' ENTRESTO has emerged as a leading drug in the congestive heart failure market. Initially slow to gain traction, ENTRESTO has become one of Novartis' key growth drivers, with revenue expected to increase in the coming years. Following its approval for use in patients with preserved ejection fraction, ENTRESTO's market presence has grown significantly. However, ENTRESTO faces growing competition. The entry of new drugs, including SGLT2 inhibitors (such as FARXIGA and JARDIANCE) and VERQUVO, poses a challenge to ENTRESTO's dominance. Additionally, Novartis is set to lose ENTRESTO's exclusivity in the United States in 2025, raising the risk of generic competition. The company is actively engaged in several patent lawsuits to protect its position. SGLT2 inhibitors have also gained a foothold in the CHF market. Although FARXIGA and JARDIANCE are established drugs, they are relatively new in this therapeutic area. The outlook for SGLT2 inhibitors in heart failure is promising, but AstraZeneca and Lilly/Boehringer will have limited time to solidify their positions, as FARXIGA's US patent expires in 2025 and JARDIANCE's in 2028. The recently approved SGLT2 inhibitor sotagliflozin may face challenges in capturing market share from these established treatments. To know more about chronic heart failure treatment guidelines, visit @ Chronic Heart Failure Management Chronic Heart Failure Pipeline Therapies and Key Companies Omecamtiv Mecarbil: Cytokinetics KERENDIA (finerenone): Bayer Tirzepatide (LY3298176): Eli Lilly and Company CardiAMP Cell Therapy: BioCardia Ziltivekimab (NN6018): Novo Nordisk REVASCOR (rexlemestrocel-L): Mesoblast Levosimendan (TNX-103): Tenax Therapeutics Semaglutide: Novo Nordisk Balcinrenone (AZD9977) + dapagliflozin: AstraZeneca Mitiperstat (AZD4831): AstraZeneca Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim Cimlanod (CXL-1427/BMS-986231): Bristol Myers Squibb Lenrispodun (ITI - 214): Intra-Cellular Therapies CRD-740: Cardurion Pharmaceuticals HU6: Rivus Pharmaceuticals Discover more about chronic heart failure drugs in development @ Chronic Heart Failure Clinical Trials Chronic Heart Failure Market Dynamics The chronic heart failure market dynamics are expected to change in the coming years. An increasing prevalence of cardiovascular diseases, fueled by aging populations and lifestyle-related risk factors such as obesity, hypertension, and diabetes, has significantly raised the demand for effective CHF treatments. Advances in medical technology, including innovative drug therapies, cardiac devices, and regenerative medicine, are expanding treatment options and improving patient outcomes. Growing awareness about heart health and early diagnosis, supported by government and non-government initiatives, is also boosting market expansion. Additionally, the rising focus on personalized medicine and the development of therapies targeting the underlying molecular mechanisms of CHF are creating lucrative opportunities. The increasing healthcare expenditure and the availability of reimbursement policies in developed and emerging economies further bolster the market's growth trajectory. Furthermore, potential therapies are being investigated for the treatment of chronic heart failure, and it is safe to predict that the treatment space will significantly impact the chronic heart failure market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the chronic heart failure market in the 7MM. However several factors may impede the growth of the chronic heart failure market. A key challenge is the underdiagnosis and delayed recognition of CHF due to overlapping symptoms with other conditions and the lack of widespread access to advanced diagnostic tools in many regions. Economic constraints, particularly in low- and middle-income countries, limit patient access to costly therapies, including advanced drugs and devices. Additionally, adherence to treatment regimens remains low due to the complexity of management protocols and the long-term nature of care, leading to suboptimal outcomes. Regulatory hurdles and lengthy approval processes for novel therapies further impede the introduction of innovative treatments. Finally, a limited understanding among general practitioners about newer guidelines and therapies reduces the referral rates to specialists, creating gaps in patient care. Addressing these barriers requires concerted efforts in education, affordability, and healthcare infrastructure. Scope of the Chronic Heart Failure Market Report Therapeutic Assessment: Chronic Heart Failure current marketed and emerging therapies Chronic Heart Failure Market Dynamics: Key Market Forecast Assumptions of Emerging Chronic Heart Failure Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Chronic Heart Failure Market Access and Reimbursement Download the report to understand which factors are driving chronic heart failure market trends @ Chronic Heart Failure Market Trends Table of Contents Related Reports Chronic Heart Failure Epidemiology Forecast Chronic Heart Failure Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the chronic heart failure epidemiology trends. Chronic Heart Failure Pipeline Chronic Heart Failure Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CHF companies, including Zensun (Shanghai) Sci & Tech, Cytokinetics, Mesoblast, Shanghai Hongyitang Biopharmaceutical Technology, Tasly Pharmaceuticals, Ionis Pharmaceuticals, Berlin Cures, CardioCell, Help Therapeutics, Eli Lilly and Company, Chong Kun Dang Pharmaceutical, Antlia Biosciences, Cardiol Therapeutics, among others. Acute Coronary Syndrome Market Acute Coronary Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ACS companies, including Novartis, Boehringer Idorsia Pharmaceuticals, Viatris, Recardio, AstraZeneca, Faraday Pharmaceuticals, DalCor Pharmaceuticals, Roche, Jiangsu Vcare PharmaTech, CeleCor Therapeutics, Novo Nordisk, Bristol Myers Squibb, Johnson & Johnson Innovative Medicine, CellProthera, BioCardia, Kancera, Amgen, Arrowhead Pharmaceuticals, Abcentra , among others. Acute Coronary Syndrome Pipeline Acute Coronary Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute coronary syndrome companies, including Janssen Research & Development, LLC, DalCor Pharmaceuticals, Hyloris Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalLicense out/in

25 Mar 2024

·www.fiercebiotech.com

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.

Phase 2OligonucleotidePhase 3Cell Therapy

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	United States	Novo Nordisk A/S	25 Jun 2024
Acute myocardial infarction	Phase 3	China	Novo Nordisk A/S	25 Jun 2024
Acute myocardial infarction	Phase 3	Japan	Novo Nordisk A/S	25 Jun 2024
Acute myocardial infarction	Phase 3	Argentina	Novo Nordisk A/S	25 Jun 2024
Acute myocardial infarction	Phase 3	Australia	Novo Nordisk A/S	25 Jun 2024
Acute myocardial infarction	Phase 3	Brazil	Novo Nordisk A/S	25 Jun 2024
Acute myocardial infarction	Phase 3	Bulgaria	Novo Nordisk A/S	25 Jun 2024
Acute myocardial infarction	Phase 3	Canada	Novo Nordisk A/S	25 Jun 2024
Acute myocardial infarction	Phase 3	Czechia	Novo Nordisk A/S	25 Jun 2024
Acute myocardial infarction	Phase 3	Denmark	Novo Nordisk A/S	25 Jun 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03926117 (RESCUE, Pubmed) Manual	Phase 2	Inflammation \| Chronic Kidney Diseases C-reactive Protein Expression	261	Ziltivekimab 7.5 mg	mjsbslmbxj(yiibsevejk) = gxnoynqjfm svriiacfap (pcdxeyzxrc )	Positive	01 Jan 2024
				Ziltivekimab 15 mg	mjsbslmbxj(yiibsevejk) = ucsmnvzyvt svriiacfap (pcdxeyzxrc )
NCT04626505 (RESCUE-2, Pubmed \| J Cardiol)	Phase 2	Atherosclerosis high-sensitivity C-reactive protein (hsCRP)	-	Ziltivekimab 15mg	slntmtudwh(bxlmshsswo) = gxapgxjuqa pbmzdxdjjd (vquvgvabjy )	Positive	01 Oct 2023
				Ziltivekimab 30mg	slntmtudwh(bxlmshsswo) = dxnhfmnuhn pbmzdxdjjd (vquvgvabjy )
NCT03926117 (RESCUE \| RESCUE Trial, CTgov)	Phase 2	Inflammation \| Chronic Kidney Diseases	264	Ziltivekimab (Placebo)	lcckmmsiaj(ywbnbmumwa) = zuosnomowv tgxzsexsnj (msvyhkcstu, iqrkodstzh - xdbslyayua) View more	-	09 Aug 2023
				Ziltivekimab (Ziltivekimab 7.5 mg)	lcckmmsiaj(ywbnbmumwa) = oqetxgeqnq tgxzsexsnj (msvyhkcstu, yuaptrvzgx - sjrnoeqmox) View more
NCT03926117 (RESCUE Trial, ASN2021)	Phase 2	Chronic Kidney Diseases serum hemoglobin \| iron homeostasis \| high-sensitivity C-reactive protein	-	Ziltivekimab 7.5 mg	icnloihler(iwxdowgqms) = tvwnnuhrmb anzjibuvya (emnjzdhxdy )	Positive	27 Oct 2021
				Ziltivekimab 15 mg	icnloihler(iwxdowgqms) = dwcghnxjqa anzjibuvya (emnjzdhxdy )
NCT02868229 (CTgov)	Phase 1/2	Anemia	61	Placebo (Placebo)	szqedhqfvy = ihvskjrnzk sxjdujfojx (btnlouipwf, myfbbhxlnf - apvbidkkae) View more	-	30 Jul 2021
				COR-001 (COR-001)	bgeilrpqdq(amxoprgvgv) = cwohxhaban myhybqjxnq (wiaftmyebf, cjfytlpnjf - nxqlrzoqgx)
NCT03926117 (RESCUE, Pubmed \| Lancet)	Phase 2	Atherosclerosis	264	Placebo	qfxaaikgac(ioeuquaimb) = vtgftvtkbn ybzkmlzlqd (zdiksztznr )	Positive	14 May 2021
ASN2019	Phase 1	Chronic Kidney Diseases	12	COR-001 5 mg	rwjxfgovaj(cjlbbufugp) = dlluvoblpo fesfiiiwtd (fgnbancvvc )	Positive	05 Nov 2019
				COR-001 15 mg	rwjxfgovaj(cjlbbufugp) = ubrtrzdrjc fesfiiiwtd (fgnbancvvc )

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