Diabetes is a chronic health condition that occurs when your body’s blood glucose, also called blood sugar, is too high. Blood sugar must be carefully regulated to ensure the body functions properly. Too much blood sugar can then cause serious damage to organs, blood vessels and nerves. Over time, that can cause health problems, such as vision loss, kidney disease, and heart disease. That’s why heart failure is closely linked to diabetes. Here we consider this issue with reference to Eli Lilly & Co (NYSE: LLY), Novo Nordisk (NYSE: NVO), Sanofi (NASDAQ: SNY), Viatris Inc (NASDAQ: VTRS), and Cardiol Therapeutics (NASDAQ: CRDL).
Individuals suffering from type 2 diabetes, when a person can’t properly use insulin made in their bodies, are two to four times more likely to develop heart failure than non-diabetics. Therefore, heart failure is a substantial risk to anyone who has diabetes.
Over 90% of diabetics suffer from type 2 in the United States. Diabetes is primarily treated with insulin. Major players in the pharma space are involved in manufacturing insulin offerings to treat people with diabetes. These include Eli Lilly & Co., Novo Nordisk, Sanofi, and Viatris.
Diabetes can lead to heart failure, with both often occurring together, reducing the quality of life and exacerbating the cost burden on individuals and the health service.
Meanwhile, heart failure presents itself in different ways, and some, such as acute myocarditis and diastolic heart failure are yet to achieve a recognized standard of care. As heart failure and diabetes are visibly linked, it makes sense that treating one could reduce the risk of succumbing to the other.
Annually, more than 550k new cases of heart failure are diagnosed in the United States. That's why Cardiol Therapeutics (NASDAQ: CRDL) is developing treatments to reduce the discomfort faced by so many living with this devastating condition.
Cardiol currently has one multi-national clinical trial ongoing, an acute myocarditis clinical trial expected to commence imminently, and a recently announced multicenter open-label pilot study in recurrent pericarditis. The company’s trials are supported by strong pre-clinical evidence showing the molecule being investigated could prove revolutionary in the cardiovascular space. Therefore, it’s providing hope to both patients and investors alike.
Cardiol Therapeutics is a clinical-stage life sciences company focused on researching and developing cannabidiol (CBD) as an anti-fibrotic and anti-inflammatory therapy to treat cardiovascular disease (CVD). Cardiol’s lead product candidate, CardiolRx™, is a pharmaceutically produced oral formulation being clinically developed for use in cardiovascular medicine.
Advising Cardiol are some of the world’s leading experts in cardiovascular medicine. The company boasts an esteemed variety of individuals on its Board of Directors and doctors on its steering committees, providing invaluable knowledge and expertise to guide Cardiol through its clinical trials.
REASONS TO SUCCEED
Diastolic heart failure represents around half of all heart failure. Furthermore, heart failure is possibly the most significant medical issue the western world faces. And this is rapidly escalating due to the rise of diabetes, obesity, and high blood pressure.
That's why Cardiol Therapeutics has made treating diastolic heart failure its overarching goal, with its ongoing pre-clinical development of a solution its priority.
Many want to see Cardiol’s trials succeed because, to date, there’s never been a satisfactory treatment for diastolic heart failure. If the Company’s drug proves to be that elusive treatment, it will surely be a cause for celebration.
With heart failure being a colossal health problem in the western world, if Cardiol’s achieves its long-term goal of developing life-changing drugs for this growing area of concern, the addressable market is huge.
INJECTION VS ORAL FORMULATION
Cardiol's administration of CardiolRx™ for acute myocarditis patients is in an oral formulation. For treating diastolic heart failure patients, the CardiolRx™ formulation is expected to be administered via subcutaneous injection, similar to the way people with diabetes use insulin.
The oral formulation of CardiolRx™ allows the treatment to be administered quickly and aggressively at very high doses. This is particularly important when dealing with acute myocarditis patients who require urgent care.
However, diastolic heart failure tends to be much more chronic than urgent and, in many cases, is something patients must learn to live with. That's why a subcutaneous formulation is a more suitable form of treatment that could lead to less frequent dosing. Cardiol believes its subcutaneous formulation will allow it to be injected and taken up via the bloodstream.
There are 64.3 million people with heart failure globally, and it remains a leading cause of death and hospitalization. Associated annual healthcare costs in the U.S. alone exceed $30bn.
If Cardiol Therapeutics achieves its long-term goal of developing a treatment for diastolic heart failure, their business has significant upside potential.
TACKLING RECURRENT PERICARDITIS
Recently, the U.S. FDA recently approved Cardiol’s Investigational New Drug Application (IND) to commence a Phase II open-label pilot study designed to evaluate the tolerance and safety of CardiolRx™ in patients with recurrent pericarditis.
Recurrent pericarditis refers to inflammation of the pericardium – the membrane, or sac, that surrounds the heart.
The study will also assess the improvement in objective measures of disease and, during an extension period, evaluate the feasibility of weaning concomitant background therapy, including corticosteroids, while taking CardiolRx™.
Recurrent pericarditis is an orphan disease in the United States, thereby making CardiolRx™ eligible for orphan drug status under the FDA’s Orphan Drug Designation program. CardiolRx™ is now eligible for orphan drug status in two indications.
The Cardiol Therapeutics team aspires to become a much bigger organization by developing life-changing drugs for this growing area of concern. Heart failure cases are a mounting burden to the national healthcare system, and rising diabetes cases compounds this problem.
Eli Lilly & Co (NYSE: LLY) is celebrating the U.S. FDA approval of Mounjaro (tirzepatide), its type 2 diabetes and weight loss medication. More than 30 million people in the U.S. have type 2 diabetes. Mounjaro is a first-in-class, dual-action drug that is injected once a week, with the dosage adjustable to the patient's needs.
Novo Nordisk (NYSE: NVO) reported strong growth last year. The Danish pharma company is a leader in the diabetes space and is also tackling obesity and Alzheimer’s disease. Novo Nordisk recently initiated a share repurchase program. The company has also announced a strategic collaboration with Flagship Pioneering to create a portfolio of transformational medicines.
Sanofi (NASDAQ: SNY) recently conducted the InRange randomized controlled trial (RCT), which met its primary and secondary endpoints for people with type 1 diabetes. The company presented its findings at the 15th International Conference on Advanced Technologies and Treatments of Diabetes.
Viatris Inc (NASDAQ: VTRS) is a global healthcare company. It provides access to medicines and sustainable operations along with support services such as diagnostic clinics, educational seminars, and digital tools. The company is committed to meeting its sustainability goals. This includes impacting 100 million patients via healthcare professional education and outreach regarding prevention, diagnosis and treatment options for cardiovascular disease, diabetes, cancer and other chronic conditions. Viatris and Biocon Biologics just launched Abevmy® (Bevacizumab), their third oncology biosimilar, in Canada.