Cardiol Therapeutics Fights Heart Inflammation With Novel Formulations

697,000 people die from heart disease every year in the United States – that is one in every five deaths. In fact, cardiovascular disease is the number one killer for most Americans per the CDC. Everyday life choices play an essential role in heart health, and sometimes unfortunate accidents can occur.

Myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart, are two disabling forms of inflammatory heart disease both caused primarily by immunological responses from viruses, and are also associated with MRNA vaccines. Although still considered rare conditions, these two serious ailments have become more recognized in the world, affecting many young, healthy people.

A study published in Science Immunology revealed a cytokine “storm” led to myocarditis in young people after their second immunization shot of the Pfizer and Moderna vaccines. A controversial topic only years ago, the sudden onset of heart attacks amongst young athletes across the nation has become a tragic phenomenon. However, adverse effects after vaccination aren’t a new concept. 

“Both myocarditis and pericarditis are not novel side-effects of vaccination,” says Dr. Andrew Hamer Chief Medical Officer of Cardiol Therapeutics, Inc. CRDL. “Other vaccinations, especially smallpox vaccination, have previously been associated with a similar increased risk of myocarditis.” Prior to joining Cardiol Therapeutics in March 2021, Dr. Hamer was the Global Development Lead at Amgen Inc. for multiple cardiometabolic medications including Repatha®, the LDL cholesterol-lowering PCSK9 inhibitor evolocumab, which generates close to a billion dollars a year.. 

While the United States offers treatment options, these therapies, and the associated hospitalizations, can be incredibly costly and prioritized based on the patient's severity. Many cases of these types of heart inflammation are mild, yet the threat, although rare, lingers for potentially millions of vaccine recipients. Misdiagnosed (or undiagnosed altogether), this condition will increase in severity - much in part due to the lack of readily available treatment. Oftentimes, healthcare professionals prefer to think: “If there’s no treatment, then why diagnose?”

Cardiol Therapeutics, Inc. CRDL seeks to protect the heart health of all ages. The company has created two formulations, CardiolRx™ and CRD-38, to heal and resolve the issues caused by inflammatory heart disease.

“Evidence suggests that treatment with CardiolRx™ leads to a reduction in the activation of inflammatory cells with subsequent reduction in the production of inflammatory cytokines,” said Dr. Hamer. “Cardiol’s research has also shown evidence that administration of CardiolRx™ leads to a reduction in mechanisms that produce scar tissue in the heart muscle and potentially may reduce existing scar tissue.”

Using cannabidiol as the main pharmaceutical ingredient, Cardiol’s novel oral and subcutaneous formulations look to resolve heart inflammation and fibrosis. Running one of the largest international studies in acute myocarditis since the steroids study of the 1990s, Cardiol is making a name as a front-runner in the treatment of this condition and other debilitating heart diseases. 

“The complication associated with vaccination has put myocarditis importantly into the public domain and allowed for greater recognition that has helped Cardiol move forward with its clinical development program,” says Cardiol Therapeutics President and CEO David Elsley. “The challenge of the disease is there's no standard of care. There's no drug with a label claim for the treatment of acute myocarditis. We’re hoping to be the first.”

The genesis of Cardiol Therapeutics came after an NIH study revealed that cannabidiol was cardioprotective in a model of diabetes-induced heart failure. The study gave hope to the idea that inflammation of the heart could be treated and prevented. Cardiol Therapeutics uses pharmaceutically manufactured cannabidiol in both of its novel therapies. Many people assume that anti-inflammatories, like steroids, can be used to treat inflammation of the heart and the cardiovascular system, yet these drugs are associated with safety and toxicology concerns. Unlike cannabidiol, steroids can cause many adverse side effects, including increased risk of infection, fluid retention, weight gain, osteoporosis, and dependency with prolonged use. Results have shown their oral formulation, CardiolRx™, shows no evidence of these adverse side effects or immunosuppression. For these reasons, the company remains optimistic as it continues to progress its clinical trials.

“Cardiol’s latest research results that were presented at the Heart Failure Society of America Meeting suggest that CRD-38, the Company’s proprietary subcutaneous formulation of pharmaceutically manufactured cannabidiol, may be addressable to the mass market of heart failure with preserved ejection fraction (HFpEF),” said Dr. Hamer. CRD-38, Cardiol’s subcutaneous formulation, showed a decrease in the visceral fat distribution in a pre-clinical model that many HFpEF patients have together with other risk factors such as obesity, diabetes, and hypertension. Visceral fat is excess body fat that grows on vital organs, which colloquially can be referred to as “bad fat.” The reduction of this fat distribution is a signal that CRD-38 has potential to become a game-changer as “the prevalence of HFpEF is increasing and now accounts for over 50% of cases of heart failure… the five-year mortality rate in patients with HFpEF exceeds 70%,” says Dr. Hamer.

Cardiol Therapeutics’ future looks bright as it continues to push its formulations through clinical trials. The company has multiple phase II trials underway for its CardiolRx formulation. With interim data in recurrent pericarditis expected in Q1 of 2024 and an accelerated enrollment pushing their completion date for the myocarditis study up to six months ahead of schedule, Cardiol is excited for the next steps of their development.

“We will answer the important questions,” Elsley said in reference to the development of their oral and subcutaneous formulations.  In addition to our lead clinical programs with CardiolRx™, CRD-38 now has the potential to be clinically developed for HFpEF, one of the largest medical markets in the world. “It's a longer development cycle, but one that is of great interest to the largest pharmaceutical companies in the world with whom we aim to partner, which could happen in 2024.” Dr. Hamer stated that by the year 2030, “the prevalence of heart failure in the United States is projected to reach approximately 8 million cases, with associated healthcare costs exceeding $70 billion.”

The evolution of medicine is long overdue. Without a cardiac MRI scan, young people suffering from myocarditis and pericarditis will continue to not be properly diagnosed or treated leading to prolonged suffering and potentially a fatal outcome. With the novel, revolutionary discoveries from Cardiol Therapeutics, inflammatory heart disease can be effectively treated, relegating the too frequent heartbreaking outcomes to memory and history books.

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