– Collaboration leverages Ascendis’ proprietary TransCon™ technologies and Novo Nordisk’s expertise in cardiometabolic diseases
Tag: Novo Nordisk
Novo Nordisk A/S: Oral semaglutide demonstrates a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes in the SOUL trial
Bagsværd, Denmark, 21 October 2024 — Novo Nordisk today announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomised trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). The trial enrolled 9,650 people with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD). As part of standard of care, 49% of patients received SGLT2i at some point during the trial.
Novo Nordisk Foundation and Technical University of Denmark press release: Bacteria in our gut could play a role in cardiometabolic disease: A new initiative aims to find out
A new Denmark-based research initiative aims to establish a potential causal link between the gut microbiome – the combined genetic material of the communities of bacteria and other microbes in the human gut – and the development of cardiometabolic diseases (CMD) such as obesity, type 2 diabetes, and cardiovascular disease. The goal is to generate knowledge that can lead to new prevention or treatment options for people living with, or at risk of, CMD.
COPENHAGEN, Denmark, May 22, 2024 /PRNewswire/ — The Novo Nordisk Foundation has committed DKK 150 million (USD 22 million) for the first phase of the Microbiome Health Initiative, a virtual research centre anchored at the Technical University of Denmark (DTU), north of Copenhagen. Professor Fredrik Bäckhed from the University of Gothenburg will be employed part-time at DTU to lead the initiative, with Professor Tine Rask Licht from DTU National Food Institute as co-Director.
Research has already shown associations between several gut bacteria or metabolites – substances produced by microbes – and CMD. In Phase 1, the initiative will therefore focus on collaborative research projects that investigate the specific effects of these bacteria or metabolites and advance understanding on how microbiome interventions could reduce the risk of CMD or help manage it. This phase will run from 2024-2028.
“Our task is to verify a causal connection between the intestinal microbiome and diseases such as cardiovascular disease and diabetes,” says Professor Licht.
“These links have been partially elucidated in laboratory trials and animal experiments, but there is yet no solid evidence of causal relationships in humans. Once we have this knowledge, the next step in the project will be to find and develop new strategies to treat or prevent these major diseases. Such new strategies will rely on modification of our gut microbiome, for example by adding new microbes, or new dietary components.”
The initiative also involves leading scientists at the University of Copenhagen, Amsterdam University Medical Centre, and the Weizmann Institute of Science in Israel, and clinicians at Odense University Hospital and Steno Diabetes Centre Copenhagen. Together, they cover a broad range of disciplines, including microbial physiology, bioinformatics, aetiology of CMD, and human interventions.
While DTU’s strength in the project is research into the impact of diet on the structure and activity of the human microbiome, the other research centres in the initiative have extensive expertise in CMD research, microbiome research, and translation into clinical settings.
“The interdisciplinary approach of the project makes it possible to coordinate research between the strongest international environments,” says Professor Bäckhed. “It is unique that we can coordinate efforts between universities and hospitals to develop the most promising treatment concepts.”
‘A whole new set of tools’Despite major advances in research and treatment, the prevalence of CMD has doubled in the last 30 years. This group of conditions – including obesity and type 2 diabetes – and associated complications such as heart attack and stroke are now the leading cause of death worldwide.
Also in the last years, advances in microbiome research have led to new understanding regarding the impact of microbes and their metabolic output on human physiology, immunity, and disease processes. In the case of CMD, evidence strongly suggests that the gut microbiome – partly due to the metabolites the microbes produce – plays a critical role, and that by making small changes, individuals could reduce their risk of, for example, developing diabetes or suffering a heart attack. This initiative aims to generate significant new knowledge that, in the future, could lead to approved microbiome-based solutions such as supplements or improved dietary guidance to prevent or treat CMD.
“The Danish microbiome research field is strong but, in order to take the critical next steps, we need an ambitious, interdisciplinary approach that also includes leading international experts,” says Birgitte Holst, Scientific Director in Medical Science at the Novo Nordisk Foundation.
“If this initiative succeeds in establishing a causal link between the microbiome and CMD, it could lead to a whole new set of tools for managing these devastating diseases and help resolve a major global health challenge.”
Phase 2, which is subject to approval following a mid-term evaluation of Phase 1, would run from 2026-2030. In this phase, the initiative would support human intervention studies and invest in infrastructure to support the development of microbes, microbial compounds, or targeted supplements for therapeutic purposes.
Editor’s Notes
About DTU National Food Institute
DTU National Food Institute conducts research into and disseminates – through advice, innovation and teaching – sustainable and value-creating solutions in the area of food and health for the benefit of society. The DTU National Food institute’s vision is to make a difference by generating future prosperity through research into food and health. The institute prevents disease and promotes health, develops new and better food products for a growing population and creates sustainable technological solutions. The institute’s tasks are carried out in a unique interdisciplinary cooperation in e.g. nutrition, chemistry, toxicology, microbiology, epidemiology, modelling and technology.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
www.novonordiskfonden.dk/en
SOURCE Novo Nordisk Foundation
Novo Nordisk Foundation, Rigshospitalet and CNIC press release: One in three people die due to atherosclerosis: A new initiative aims to find new ways to prevent it
COPENHAGEN, Denmark, May 16, 2024 /PRNewswire/ — Globally, cardiovascular diseases due to atherosclerosis – the build-up of plaque in arteries – are the leading cause of death. A new Danish-Spanish research collaboration aims to develop methods to detect atherosclerosis at earlier ages…
Novo Nordisk to acquire Cardior Pharmaceuticals and strengthen pipeline in cardiovascular disease
Bagsværd, Denmark, and Hannover, Germany, 25 March, 2024 – Novo Nordisk and Cardior Pharmaceuticals today announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. Cardior is a leader in the discovery and development of therapies that target RNA as a means to prevent, repair and reverse diseases of the heart. The company’s therapeutic approach targets distinctive non-coding RNAs as a platform for addressing root causes of cardiac dysfunctions with an aim to achieve lasting patient impact. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure. The acquisition is an important step forward in Novo Nordisk’s strategy to establish a presence in cardiovascular disease. Novo Nordisk aims to build a focused, impactful portfolio of therapies through internal and external innovation to address the significant unmet needs that still exist within cardiovascular disease, the most common cause of death globally. “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to halt or partially reverse the course of disease for people living with heart failure.” CDR132L is designed to halt and partially reverse cellular pathology by selectively blocking abnormal levels of the microRNA molecule miR-132, potentially leading to long-lasting improvement in heart function. In a phase 1b trial published in the European Heart Journal1, CDR132L was reported to be safe and well tolerated and the results suggested cardiac functional improvements in people with heart failure compared to placebo. CDR132L is currently being investigated in the phase 2 trial HF-REVERT in 280 people with heart failure with reduced ejection fraction (HFrEF) who have previously suffered a heart attack (myocardial infarction). The first patient was dosed in the HF-REVERT trial in July 2022. Novo Nordisk plans to initiate a second phase 2 trial that will investigate CDR132L in a chronic heart failure population with cardiac hypertrophy – a condition that causes the walls of the heart muscle to become thick and stiff, affecting the heart’s ability to pump blood. “This acquisition is a reflection of CDR132L’s transformative potential as a disease-modifying therapy for heart failure,” said Claudia Ulbrich, MD, CEO and co-founder of Cardior. “Novo Nordisk is the ideal partner based on its deep clinical and commercial expertise combined with its resources to accelerate our late-stage development programme, including through larger registrational studies. We look forward to advancing CDR132L towards market approval.” The closing of the acquisition is subject to receipt of applicable regulatory approvals and other customary conditions and is expected to happen in the second quarter of 2024. The transaction will not impact Novo Nordisk’s previously communicated operating profit outlook for 2024 or the ongoing share buy-back programme. Novo Nordisk will fund the acquisition from financial reserves. About heart failure Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body’s needs for blood and oxygen. The condition leads to frequent hospitalisations, and more than half of people diagnosed with heart failure die within five years2. Heart failure affects more than 65 million people globally and is most commonly caused by heart conditions such as ischaemic heart disease, cardiomyopathy or high blood pressure3. The condition cannot be cured. Current therapies can slow but not halt disease progression4, and morbidity and mortality remain high5. About Cardior’s approachCardior works to identify and counteract the molecular mechanisms of the broad area of ischaemic-induced heart failure as well as specific cardiac diseases such as hypertrophic and dilated cardiomyopathies. Cardior primarily seeks to advance a novel class of antisense oligonucleotides (ASOs) targeting so-called non-coding RNAs (ncRNAs) that are able to act on several key disease pathways simultaneously, triggering a concerted therapeutic effect against key hallmarks of heart disease, including cardiac hypertrophy, fibrosis, impaired contractility and reduced vascularization. Although ncRNAs are not translated into proteins, they are important for the regulation of critical cellular processes and their dysregulation is a hallmark of many diseases. With its deep knowledge in RNA biology, Cardior is developing a clinically-oriented approach to restore normal levels and functions of these key players in the pathological processes of cardiac diseases. About Novo NordiskNovo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 63,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. About CardiorCardior Pharmaceuticals is a leading clinical-stage biopharmaceutical company pioneering the discovery and development of RNA-based therapeutics designed to prevent, repair and reverse diseases of the heart. Cardior’s therapeutic approach uses distinctive non-coding RNAs as an innovative platform for addressing the root causes of cardiac dysfunctions. The company aspires to bring transformative therapeutics and diagnostics to patients and thereby make a lasting impact on the treatment of cardiac diseases worldwide. Contacts for further information Media: Ambre James-Brown+45 3079 9289abmo@novonordisk.com Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.comInvestors: Daniel Muusmann Bohsen+45 3075 2175 dabo@novonordisk.comJacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comDavid Heiberg Landsted +45 3077 6915 dhel@novonordisk.comMark Joseph Root (US) +1 848 213 3219mjhr@novonordisk.comSina Meyer +45 3079 6656azey@novonordisk.comFrederik Taylor Pitter +45 3075 8259fptr@novonordisk.comCardior media Trophic CommunicationsStephanie May+49 171 1855682may@trophic.eu 1 Täubel J et al. European Heart Journal 2021 Jan 7;42(2):178-188 Novel antisense therapy targeting microRNA-132 in patients with heart failure: results of a first-in-human Phase 1b randomized, double-blind, placebo-controlled study – PubMed (nih.gov) 2 Jones NR et al. European Journal of Heart Failure 2019 Nov; 21(11): 1306–1325 Survival of patients with chronic heart failure in the community: a systematic review and meta‐analysis – PMC (nih.gov) 3 Bragazzi NL et al. Preventive Cardiology 2021;28(15):1682-1690 Burden of heart failure and underlying causes in 195 countries and territories from 1990 to 2017 – PubMed (nih.gov) 4 McDonagh TA et al. European Heart Journal 2021 Sep 21;42(36):3599-3726 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure – PubMed (nih.gov) 5 Savarese G, Lund LH. Cardiac Failure Review. 2017;03(01):7-11 Global Public Health Burden of Heart Failure – PubMed (nih.gov)
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Novo Nordisk enters into research collaborations with Omega Therapeutics and Cellarity on novel treatment approaches for cardiometabolic diseases
Omega collaboration will leverage the company’s platform to develop an epigenomic controller as part of a new approach to obesity management Cellarity collaboration will build upon initial work and engage the company’s platform to develop a small molecule therapy in […]
Novo Nordisk A/S: Semaglutide 2.4 mg (Wegovy®) cardiovascular outcomes data presented at American Heart Association Scientific Sessions and simultaneously published in New England Journal of Medicine
Semaglutide 2.4 mg delivered a statistically significant 20% risk reduction in major adverse cardiovascular events (MACE) with risk reductions demonstrated consistently across age, gender, ethnicity and starting body mass index (BMI). Beneficial effects were seen consistently across measured cardiovascular endpoints […]
Novo Nordisk to acquire ocedurenone for uncontrolled hypertension from KBP Biosciences
Bagsværd, Denmark and Singapore, 16 October 2023 – Novo Nordisk A/S and KBP Biosciences PTE., Ltd. today announced that Novo Nordisk has agreed to acquire ocedurenone for uncontrolled hypertension with potential application in cardiovascular and kidney disease from KBP Biosciences […]
Valo Health and Novo Nordisk to collaborate to discover and develop novel treatments for cardiometabolic diseases using human data and artificial intelligence
Bagsværd, Denmark and Boston, Massachusetts, US, 25 September 2023 – Novo Nordisk A/S and Valo Health, Inc. today announced they have entered into an agreement to discover and develop novel treatments for cardiometabolic diseases based on Valo’s large human dataset and computation powered by artificial intelligence (AI). […]
Novo Nordisk A/S: Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in the SELECT trial
Bagsværd, Denmark, 8 August 2023 – Novo Nordisk today announced the headline results from the SELECT cardiovascular outcomes trial. The double-blinded trial compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to standard of care for prevention of major adverse cardiovascular […]
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