Cardiol Therapeutics (TSE: CRDL) is a clinical-stage biotechnology company focused on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease.
Its lead clinical product, CardiolRx, is a pharmaceutically produced oral cannabidiol (CBD) formulation being developed for the treatment of inflammatory heart disease. Cannabidiol is the second most prevalent cannabinoid in cannabis after THC, and it’s free from the psychotropic effects of THC.
There are two inflammatory heart conditions: myocarditis and pericarditis.
Myocarditis is a rare disease that causes the inflammation of the heart muscle that enlarges and weakens the heart. Pericarditis is the inflammation of the tissues around the heart.
Myocarditis' most common cause is a viral infection. The person’s immune system creates inflammation to eliminate the infection and repair damaged tissues. If the inflammation persists after the body clears the virus, it can weaken the heart, making it more difficult to pump enough blood to the rest of the body.
The main symptoms of myocarditis are chest pain, shortness of breath, and irregular heartbeat.
Myocarditis and COVID-19
COVID-19 is considered primarily a respiratory disease. However, an increasing number of reports indicate that COVID-19 patients are at higher risk of developing cardiovascular complications.
A study by Icahn School of Medicine at Mount Sinai in New York City found that COVID-19 patients with cardiovascular disease increase their risk of developing heart failure during their illness. And Qiurong Ruan, Kun Yang, et al., found that up to 7% of COVID-19 related deaths were due to myocarditis.
Additionally, mRNA vaccines have been linked to cases of heart inflammation.
Since April 2021, there have been more than a thousand reports of cases of inflammation of the heart happening after mRNA COVID-19 vaccinations in the United States. In Canada, as of June 18, there have been 65 cases of heart inflammation out of 31.4 million vaccines administered.
In September 2020, Cardiol received approval from the U.S. Food and Drug Administration for its Investigational New Drug (IND) application to commence a Phase II/III clinical trial to investigate the efficacy and safety of CardiolRx in hospitalized COVID-19 patients with a prior history of cardiovascular disease and the first patient was enrolled in April. The trial is expected to be completed by the end of this year.
Additional products in the pipeline
Cardiol Therapeutics is developing a subcutaneous formulation of CardiolRx to achieve higher bioavailability than an oral formulation for the treatment of chronic heart failure.
Heart failure is the leading cause of death in Canada and the United States. According to the Centers for Disease Control and Prevention (CDC), about 5.7 million adults in the United States have heart failure and about half of people who develop heart failure die within 5 years of diagnosis.
Also, the company is planning an international Phase II study to investigate the therapeutic effects of CardiolRx on myocardial recovery in patients with acute myocarditis.
Extensive preclinical investigations by Cardiol and others in models of cardiovascular inflammation have demonstrated that cannabidiol has significant anti-inflammatory and anti-fibrotic activity, as well as anti-ischemic, and antiarrhythmic action and that it improves myocardial function in models of heart failure.
Additionally, published third-party research has shown that cannabidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow.
Conclusion
Cardiol Therapeutics is a microcap company with C$ 134 million in market capitalization that offers what an investor looks for in a clinical-stage biotechnological company: a product already in aPhase II/III clinical trial and about to commence a Phase II clinical trial, with both indications having great market potential; money to fund its operation; and an experienced management team.
There is currently no specific treatment for acute myocarditis. Some patients are given corticosteroid therapy to help reduce inflammation, while others can receive diuretic therapy to treat fluid overload. Both have limitations and/or debilitating side-effects.
Cardiol believes there is a significant opportunity to develop CardiolRx as a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an Orphan Drug. If approved, it would give significant benefits to the Company, including 7-year marketing exclusivity of CardiolRx and 25% federal tax credit for expenses incurred in conducting clinical research within the United States.
On May 12, the Company announced it raised $22 million from a stock offering, more than enough to fund Cardiol’s activities for a whole year, according to its financial statements. The Company intends to use the net proceeds to advance the research and clinical development programs and for general corporate purposes.
Also this year, the Company further strengthened its team by appointingDr. Andrew Hamer as the new Chief Medical Officer. Most recently, Dr. Hamer served as Executive Director, Global Development-Cardiometabolic at Amgen Inc., where he led the Global Development group for Repatha, the LDL cholesterol-lowering PCSK9 inhibitor evolocumab, which generated revenues of almost $900 million in 2020.
Although drug approvals tend to be a binary outcome, because there is always a risk that a new drug fails in a late-stage clinical trial, the rewards if Cardiol can prove the effectiveness and safety of its CardiolRx could be enormous for both patients and investors.