It is no secret that people with underlying health conditions are the most vulnerable potential COVID-19 patients. Prominent among these hazardous underlying conditions is heart disease. According to the Centers for Disease Control, patients with heart failure, coronary artery disease, and other heart conditions are particularly at risk for severe illness from the virus.
The connection between COVID-19 and the heart is, along with many other aspects of this novel disease, slowly coming into focus. There is mounting evidence that COVID-19 may also produce heart injury in patients, and excessive inflammation (sometimes resulting in a fatal cytokine storm) may be the culprit. This scientific article lays out the case pretty clearly: treating heart inflammation is a key to avoiding catastrophic results.
There is one Canadian company, already focused on developing therapies for heart conditions, clearly forging ahead in this area. Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) filed a new patent application covering the use of cannabidiol (CBD) to improve the outcome of patients with COVID-19. Cardiol has already planned to study CBD as a primary active in the treatment for heart failure and acute myocarditis. With all of the evidence surrounding heart disease and negative COVID-19 outcomes, the company is naturally progressing its research to determine whether CBD can help a) improve outcomes for patients with pre-existing heart conditions or risk factor for heart disease, and b) decrease the occurrence of cardiovascular complications in such patients.
Inflammation is the Enemy
Chronic heart failure (HF) is common, with an estimated six million adults suffering from the disease in Canada and the United States. Approximately 50% of patients with HF have a condition known as HF with preserved ejection fraction (HFpEF), wherein the contraction of the heart remains relatively normal, but there is an abnormality in the filling of the heart during the relaxation phase. Over the last twenty years, there have been no major advancements in the treatment of this form of HF. Current standard of care is the use of diuretics to decrease inflammation, and there is no known cure. Inflammation in the heart tissue leads to increased production of cytokines, increased oxidative stress, death of heart cells, and eventually to the creation of fibrosis, which leads to increased stiffness of the heart tissues that further exacerbates the problem. In this way, the body creates a destructive inflammatory feedback loop. It is similar to the way doctors discuss the often-fatal cytokine storms resulting from COVID-19.
Acute myocarditis is another problematic form of heart disease and is the most common cause of sudden cardiac death in people under the age of 35. It is most often caused by a viral infection followed by the body’s inflammatory response, similar in many ways to what doctors are seeing with COVID-19 patients.
Cardiol is advancing studies on the efficacy of targeted CBD treatments for both of these heart conditions. The targeting mechanism consists of proprietary nanotherapeutics technology that enables water-insoluble drugs (like fat-based CBD) to be distributed in the bloodstream and accumulate in the affected heart tissues. In March, the company’s researchers presented evidence that these nanoparticles accumulated in diseased heart tissues in excess of 100 times more than in the healthy control group. Clearly, Cardiol has the technology to effectively deliver active pharmaceutical ingredients to targeted tissues.
With the decades-long prohibition of cannabis and minimal scientific research into the plant, there is a lot to be discovered about the potential benefits of the wide variety of active ingredients, called cannabinoids, prevalent in cannabis. One in particular, cannabidiol (CBD), has shown potential for treating conditions ranging from epilepsy to sleep disorders to PTSD. It is available in copious amounts from both cannabis and hemp plants and is not psychoactive.
Research shows that “CBD reduces the levels of pro-inflammatory cytokines, inhibits T cell proliferation, induces T cell apoptosis, and reduces migration and adhesion of immune cells.” These are just the types of actions needed to treat heart disease, as well as to mitigate an over-responsive immune system. Here are some more sources for research on the topics of heart failure, inflammation, and CBD.
Cardiol Putting It Together
Cardiol Therapeutics is combining a number of threads to attack heart disease, and now COVID-19. It starts with the experienced team dedicated to improving heart patient outcomes. The company is partnering with key international research organizations, including the renowned Houston Methodist DeBakey Heart & Vascular Center. Cardiol also partners with Purisys, LLC and Dalton Pharma Services for the formulation and production of its own proprietary pure pharmaceutical CBD, which it uses in its research and plans to launch commercially to Canadian medical cannabis patients.
The nanotechnology ensures targeted delivery of the CBD to affected tissues, overcoming a common problem of cannabinoid and other lipid-based therapies. The CBD it uses is produced in cGMP and FDA-approved facilities, legitimizing the drug, and perhaps increasing the chances it could be approved should the research bear fruit. The recent intellectual property filing could serve to protect Cardiol should it find, as preliminary research indicates, that its CBD therapies help those with heart conditions, and by extension help COVID-19 patients achieve better outcomes.
A look at the development of some comparable companies can shine some light on Cardiol’s potential. GW Pharma’s cannabis-derived Epidiolex was approved by the FDA in 2018 for the treatment of two rare forms of epilepsy. The company had previously introduced Sativex, a cannabis-derived oral spray for the relief of multiple sclerosis (MS) symptoms and cancer-related neuropathic pain. GW’s incremental success in developing and getting approval for these drugs led to stock appreciation from $10 in the summer of 2013, to a high of about $180 in May 2019 (currently around $130).
More recently, and in the heart disease arena, MyoKardia announced positive Phase 3 results for its candidate to treat obstructive hypertrophic cardiomyopathy (HCM). The announcement triggered a run up of the company’s stock, from approximately $60 to $120 (currently around $90). Earlier results had similar effects, with Phase 1 safety trials pushing the stock from $10 to $20, followed by Phase 2 results catapulting the stock over $40 in 2017.
Cardiol recently closed a financing of $17.25 million, intended to support its clinical development program as well as the commercial launch of its pharmaceutical CBD product. The company also brought on noted CNBC Fast Money commentator Steven Grasso as business advisor to raise its profile in the U.S. investment community. The table is set. Keep an eye out for further developments from Cardiol Therapeutics as the company seeks to emulate the success of its peers in both the heart and CBD fields.