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Novo Nordisk $1.1bn Heart Disease Deal: What We Know About Cardior Pharmaceuticals Drug CDR132L

Last Updated March 26, 2024 12:14 PM
Giuseppe Ciccomascolo
Last Updated March 26, 2024 12:14 PM

Key Takeaways

  • Novo Nordisk acquires Cardior Pharmaceuticals for $1.1 billion.
  • The deal bolsters its presence in the cardiovascular disease (CVD) treatment market.
  • The key drug in focus is CDR132L, an oligonucleotide therapy targeting miR-132 RNA.
  • This acquisition follows a series of strategic moves by Novo Nordisk in the CVD sector.

Novo Nordisk has announced  its acquisition of Germany-based Cardior Pharmaceuticals  for up to $1.1 billion to bolster its cardiovascular pipeline. The deal, slated to finalize in the second quarter of 2024, marks a strategic move by the Danish drugmaker to strengthen its foothold in cardiovascular diseases.

This acquisition comes as Novo Nordisk experiences significant growth in sales of its diabetes and obesity therapies, further enhancing its position in the pharmaceutical market.

What’s CDR132L?

CDR132L, a type of medication designed to target specific genetic material within the heart cells, targets a non-coding RNA known as miR-132, a specific molecule in the heart that influences its function, which the drug aims to regulate. The drug is intended to stop and potentially reverse changes in the heart’s structure that can lead to heart failure.

In phase 1b trials , the drug showed promising safety and initial improvements in cardiac function. These improvements include a reduction in the heart failure biomarker NT-proBNP – a special kind of biomarker that doctors use to understand how well your heart is working – and a narrowing of the QRS complex, which shows the electrical activity of a heart squeeze.

Should the deal proceed as planned, Novo Nordisk intends to initiate a second phase 2 trial of CDR132L targeting chronic heart failure patients with cardiac hypertrophy – a condition characterized by thickening and stiffening of the heart muscle walls.

Novo Nordisk highlighted CDR132L’s unique mechanism of action and its potential as a pioneering therapy for halting or partially reversing heart failure progression, a condition in which the heart isn’t pumping blood as well as it should.

Currently, CDR132L is undergoing evaluation in a phase II trial involving 280 patients with left-sided heart failure post-myocardial infarction, which means that, after a heart attack, the left side of the heart is not pumping blood effectively. This can lead to symptoms like shortness of breath, fatigue, and fluid buildup in the lungs.

The trial is expected to conclude by March 2025, according  to ClinicalTrial.gov. Novo Nordisk plans to broaden CDR132L’s indications and explore its efficacy in a Phase II trial targeting chronic heart failure patients with cardiac hypertrophy.

Under Phase-II

According  to US National Center for Biotechnology Information, which examined the drug, inhibiting microRNA – small endogenous RNA molecules – presents a promising strategy for preventing and reversing adverse cardiac remodeling in heart failure.

This means that stopping these tiny molecules from doing their usual job, could help prevent or reverse the harmful changes that happen to the heart muscle in heart failure. This could be a hopeful approach for treating heart failure and improving heart function.

CDR132L has demonstrated beneficial effects on left ventricular structure and function in relevant preclinical models. Moreover, it exhibited safety and tolerability in a phase 1b study involving stable chronic patients with cardiovascular issues.

Patients with acute myocardial infarction – lack of oxygen in the heart – and subsequent left ventricle dysfunction face limited therapeutic options may benefit from early treatment with CDR132L.

The HF-REVERT trial, a phase 2 study, aims to evaluate the efficacy and safety of CDR132L in patients with cardiovascular issuer. This  placebo-controlled study involves 280 participants and compares the effects of 5 and 10 mg/kg doses of CDR132L, administered as three single intravenous doses 28 days apart, in addition to standard care .

After the initial six months where the trial is double-blinded, there will be another six months where everyone involved (participants and researchers) knows who is receiving the treatment. This is called an “open-label” period. During this time, they will continue to observe and gather data to see how the participants fare over a longer period.

The findings  from the trial can potentially validate the concept of microRNA inhibition for preventing cardiac issues in patients. These results will inform the design of subsequent outcome trials to further evaluate the efficacy of CDR132L in heart failure management.

Novo Grows In Cardiovascular Drugs Sector

Novo Nordisk has inked the Cardior deal just weeks after finalizing a $1.46 billion collaboration  with US biotech Neomorph, focusing on cardiometabolic and rare diseases. Additionally, Novo has entered into cardiometabolic disease partnerships  with Omega Therapeutics and Cellarity, along with an $11 billion agreement to acquire manufacturing capacity for obesity and diabetes therapies from Catalent.

At the forefront of Novo’s pipeline is the once-monthly anti-IL-6 antibody ziltivekimab, currently in phase 3 trials for heart failure and atherosclerotic cardiovascular disease in patients with chronic kidney disease and heart failure with preserved ejection fraction. Also, the anti-amyloid therapy PRX004 is in phase 2 for rare heart disease ATTR cardiomyopathy, which is a disorders characterized by a misfolded precursor protein.

Novo Nordisk has recently succeeded in cardiovascular indications with its blockbuster weight loss therapy, Wegovy (semaglutide). In a significant development earlier this month, the US Food and Drug Administration (FDA) approved  Wegovy. This drug helps to mitigate the risk of cardiovascular death, heart attack, and stroke in obese or overweight adults with cardiovascular disease.

In July 2023, Novo Nordisk forged a research alliance with Eleven Therapeutics to identify novel nucleic acid molecules for treating cardiometabolic diseases, leveraging Eleven’s DELiveri platform. DELiveri employs DNA-encoded libraries, in conjunction with machine learning and AI technologies, to pinpoint conjugates capable of transporting therapeutic molecules.

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