University of Florida men’s basketball star, Keyontae Johnson, collapsed during a game in December and was rushed to the hospital. Released ten days later, the diagnosis was acute myocarditis, or acute inflammation of the heart, a rare but potentially fatal condition that is most often attributable to the effects of a viral infection. Johnson’s season is over, but he is on the path to recovery — many people are not as fortunate. Acute myocarditis is the most common cause of sudden cardiac death in people under 35 years of age.
Keyontae Johnson was diagnosed with COVID-19 during the summer, raising the possibility that the two conditions are linked. Acute myocarditis is usually triggered by a viral infection, and there is evidence that the SARS-CoV-2 virus can cause it even a month or more after COVID symptoms end. Dr. Curt Daniels, director of sports cardiology at Ohio State University, reported a three month study in which about 15 percent of athletes who had the virus, usually asymptomatic cases, showed signs of myocarditis in MRIs. As with everything COVID-related, there is much to learn about the connection between the two diseases — they are both problematic and very much worth addressing.
Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) is initiating clinical trial programs both for the treatment of acute myocarditis and for the treatment of COVID-19 patients with cardiovascular complications. The drug candidate in both cases is CardiolRx™, Cardiol’s ultra-pure oral formulation of cannabidiol (CBD), an active ingredient found in the cannabis plant known for, among other effects, its anti-inflammatory properties. The acute myocarditis trial has been in the pipeline for some time, and a Phase I clinical study was recently completed. The COVID-19 trial has come together quickly. In September 2020, the U.S. Food and Drug Administration approved an Investigational New Drug (IND) application for a combined Phase II/III trial, followed by Cardiol’s appointment of a contract research organization to help conduct the trial.
Cardiol Therapeutics recently announced the completion of the Phase I clinical study of CardiolRx. Analysis of the final results of this safety, tolerability, and pharmacokinetics trial will provide the company information to optimize dosing levels for its planned Phase II international clinical trial for the treatment of acute myocarditis.
Of note here is the likelihood that the potential treatment would qualify for the FDA’s (and the European Union’s) orphan drug designation. In the U.S., the program is designed to foster and encourage development of drugs to treat rare conditions affecting less than 200,000 people, as these diseases have often been overlooked by larger pharmaceutical companies. Don’t let the designation fool you, though. There is plenty of profit potential in developing an orphan drug. Under the program, GW Pharmaceuticals (NASDAQ: GWPH) developed Epidiolex, the only FDA-approved CBD formulation to date, as a treatment for two rare forms of childhood epilepsy called Lennox-Gastaut and Dravet syndromes. Approximately 30,000 children in the U.S. suffer from these conditions. GW Pharmaceuticals reported revenue of $137.1 million in its most recent quarter, driven largely by U.S. sales of Epidiolex, and currently trades with a market capitalization of approximately $4.3 billion. As a frame of reference, acute myocarditis is thought to affect somewhere around 70,000 people in the U.S. annually.
COVID-19 (and the Heart)
Cardiol is a company focused on heart conditions. While conducting its research, the company identified CBD as a potential treatment for a variety of problematic cardiovascular conditions. In pre-clinical studies, Cardiol has demonstrated the anti-inflammatory and cardioprotective properties of CBD. Cardiol’s findings were accepted to the American College of Cardiology’s 69th Annual Scientific Session and Expo held virtually in late March 2020, with data showing CardiolRx reduces fibrosis, hypertrophy (enlargement), and BNP (a marker indicating cardiac injury) in heart tissue. Then along came COVID-19 and mounting evidence that poor outcomes for patients were often linked to either pre-existing cardiovascular complications or to risk factors for those conditions.
Cardiol got to work quickly, filing a U.S. provisional patent application patent application covering the use of CBD to improve outcomes for COVID-19 patients in May 2020. The company had already assembled an impressive independent Clinical Steering Committee consisting of esteemed cardiology experts to design, guide, and oversee its acute myocarditis trial program, so a potential COVID-19 study was added to the docket. In late September, the FDA approved Cardiol’s IND application for a combined Phase II/III trial and in December the company appointed contract research organization Worldwide Clinical Trials to assist with conducting the trial.
An interesting aspect of these trials (and Cardiol’s other primary focus on the treatment of heart failure), is the potential for overlap. As Cardiol’s President and CEO David Elsley stated, “While this potentially registrational trial is designed primarily to evaluate the impact of CardiolRx™ on reducing mortality and major cardiovascular outcomes in COVID-19 patients who have a prior history of, or risk factors for, cardiovascular disease, this important study will also investigate the therapy’s influence on key markers of inflammatory heart disease. These findings are expected to provide invaluable data with respect to the therapeutic potential of CardiolRx™ in the treatment of inflammatory heart disease, including heart failure which remains a leading cause of death and disability and a major economic burden in developed nations.”
There is much to be learned about the connection between COVID-19 and the heart regarding both severe cases involving hospitalization, as well as less severe and even asymptomatic cases resulting in acute myocarditis. Cardiol Therapeutics is advancing clinical research that should shed light on the relationship at a crucial stage in the pandemic, with the hope that the anti-inflammatory and cardioprotective properties of CBD can provide relief and improve outcomes for patients. Stay tuned as Cardiol continues to share its findings.