Cardiol Therapeutics has announced promising results from a preclinical study confirming the cardioprotective properties of its pharmaceutical cannabidiol (CBD) formulation in a model of heart failure. The data, which were accepted for presentation at the American College of Cardiology's (ACC) 69th Annual Scientific Session & Expo, demonstrate significant anti-inflammatory and anti-fibrotic activity.
In the study, researchers evaluated Cardiol's pharmaceutically produced (cGMP) cannabidiol formulation in a non-ischemic heart failure model. Heart failure was induced through a four-week infusion of angiotensin II, which produces hypertension, cardiac enlargement, and subsequent heart failure. Two dosages of the CBD formulation (or placebo) were administered by subcutaneous injection every three days throughout the four-week period.
The results revealed that Cardiol's formulation significantly reduced hypertrophy (cell enlargement) and produced a dose-dependent reduction of key inflammation markers. Additionally, the treatment decreased fibrosis and lowered B-type Natriuretic Peptide (BNP) expression, a clinical indicator widely used to assess heart failure severity.
"The data accepted for presentation at the ACC underscore the importance of Cardiol's research initiatives aimed at developing novel therapeutic strategies to address the devastating consequences of heart failure," stated David Elsley, President and CEO of Cardiol Therapeutics. "The data also support our long-standing view concerning the powerful anti-inflammatory, anti-fibrotic, and cardioprotective properties of pharmaceutically produced cannabidiol."
Implications for Acute Myocarditis Treatment
These findings are particularly significant for Cardiol's planned Phase 2 international trial in acute myocarditis, an inflammatory form of heart failure that represents a leading cause of sudden cardiac death in children and young adults. The planned study will investigate the company's pharmaceutically produced, high concentration, pure cannabidiol formulation (CardiolRx) in up to 100 patients with acute myocarditis.
Acute myocarditis, characterized by inflammation of the heart tissue, remains the most common cause of sudden cardiac death in people under 35 years of age. Currently, treatment options for this condition are limited, highlighting the need for novel therapeutic approaches.
CardiolRx: A Pharmaceutical-Grade CBD Formulation
CardiolRx, the company's lead product, is formulated to be the most consistent cannabidiol formulation on the market. It is pharmaceutically produced under current Good Manufacturing Practice (cGMP) standards and is THC-free (less than 5 ppm). This pharmaceutical-grade formulation distinguishes it from many commercially available CBD products.
Beyond acute myocarditis, Cardiol is also developing its cannabidiol formulation for the treatment of chronic heart failure, a leading cause of death and hospitalization in North America. The economic burden of heart failure is substantial, with associated annual healthcare costs in the U.S. alone exceeding $30 billion.
Innovative Delivery Technology
In addition to its current formulation, Cardiol is developing proprietary nanotechnology to uniquely deliver pharmaceutical cannabidiol and other anti-inflammatory drugs directly to sites of inflammation in the heart associated with heart failure. This targeted delivery approach could potentially enhance therapeutic efficacy while minimizing systemic side effects.
The company also plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is pursuing distribution opportunities in Europe and Latin America.
Scientific Foundation for Future Development
The study results provide an encouraging scientific foundation for Cardiol's therapeutic development program. By confirming the anti-inflammatory, anti-fibrotic, and cardioprotective properties of pharmaceutically produced cannabidiol, these findings support the company's approach to addressing unmet needs in cardiovascular medicine.
Heart failure remains a significant public health challenge, and novel therapeutic strategies are urgently needed. Cardiol's research initiatives represent a promising direction in the development of innovative treatments for this devastating condition.
As the company advances its clinical programs, the medical community will be watching closely to see if these preclinical results translate into meaningful benefits for patients with acute myocarditis and other forms of heart failure.
