FDA Approves Landmark COVID/Heart/CBD Clinical Trial
September 30th, 2020
The US Food and Drug Administration (FDA) recently announced a potentially major development in the quest to improve outcomes for COVID-19 patients. The agency approved an Investigational New Drug application by Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) that opens the door for Cardiol to conduct its Phase II/III trial. The trial, designed by leading experts on inflammatory heart disease, will test the cardioprotective properties of cannabidiol (CBD) for COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease (CVD).
Heart Issues and COVID
The US Centers for Disease Control (CDC) lists pre-existing serious heart conditions as a major risk factor for COVID-19 patients. The CDC provided data for cases in the US through May, and found that 45% of hospitalized patients had underlying conditions, with CVD the most common of these at 32%. The European Society of Cardiology notes that the body’s inflammatory response to the COVID-19 viral infection can stress the cardiovascular system and warns that, “Individuals with heart conditions, such as heart failure, dilated cardiomyopathy, advanced forms of arrhythmogenic right ventricular cardiomyopathy and patients with congenital cyanotic heart disease are at highest risk.”
To be clear, CVD does not increase the chances of being infected, but rather increases the chances of severe complications should one become infected. COVID was originally thought to be primarily a respiratory disease, but the link to heart conditions has the scientific community scrambling to precisely identify the nature of that link and to come up with treatments that can improve outcomes for these patients.
Cardiol’s Potential Therapy
Cardiol Therapeutics is a Canadian company started and run by a team of cardiovascular disease experts. The CEO, David Elsley, founded Vasogen, Inc. back in 1990 to develop therapies for heart failure and other inflammatory conditions. CMO Dr. Eldon R. Smith was the Editor-in-Chief of the Canadian Journal of Cardiology following a long stint at the University of Calgary as Head of Cardiology and Dean of Medicine.
The company took note of a wealth of clinical evidence suggesting that CBD demonstrates anti-inflammatory properties that could prove effective in treating inflammation-related heart conditions such as acute myocarditis and heart failure. Following its own pre-clinical studies, Cardiol is even more convinced of the potential value of CBD. The company is developing a patented subcutaneous formulation to improve the bioavailability of CBD.
Cardiol formed a clinical trial pipeline to investigate CBD as a treatment for acute myocarditis (Phase 1 launched in August 2020) and heart failure. Along the way, the company noticed the connection between CVD and severe COVID-19 outcomes, filing a patent in early May 2020 to cover “the administration of CBD to reduce the severity of disease in COVID-19 patients with pre-existing cardiovascular conditions, and to prevent the progression of such conditions.”
Cardiol’s Phase II/III trial will be conducted at major centers in the United States, where the prevalence of COVID-19 remains high and will be overseen by an independent steering committee, consisting of an impressive collection of inflammatory heart disease experts: Dr. Dennis McNamara (Chair), Professor of Medicine and Director of the Heart Failure/Transplantation Program, University of Pittsburgh; Dr. Leslie Cooper (Co-Chair), Chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine and Chair of the Department of Cardiovascular Medicine, Mayo Clinic; Dr. Arvind Bhimaraj, Medical Director, Advanced Heart Failure, Mechanical Circulatory Support and Heart Transplant Programs, Houston Methodist Hospital; Dr. Barry Trachtenberg, Director, Cardio-Oncology and Cardiac Amyloid Programs, Associate Director, Mechanical Circulatory Support Program, Houston Methodist Hospital; Dr. Wilson Tang, Director of the Center for Clinical Genomics, Research Director, and staff cardiologist in the Section of Heart Failure and Cardiac Transplantation Medicine, Cleveland Clinic; Dr. Peter Liu, Chief Scientific Officer and Vice President of Research, University of Ottawa Heart Institute; Dr. Carsten Tschöpe, Vice Director of the Dept. of Cardiology, Charité University Medicine Berlin, Germany; Dr. Matthias Friedrich, Professor of Medicine and Chief, Cardiovascular Imaging, McGill University Health Centre.
Where It’s Headed
The hope is to prove efficacy “in preventing cardiovascular and pulmonary complications in hospitalized patients, with a confirmed diagnosis of COVID-19 within the previous 24 hours, and who have pre-existing CVD and/or significant risk factors for CVD.” The successful IND application provides Cardiol an expedited regulatory approval process that should not only shorten the duration of the clinical program from start to finish but also reduce costs from a standard clinical program.
Cardiol expects to initiate the trial in Q4 with results expected in H2 2021. Along with the company’s Phase I trial in Canada, expected to wrap up by the end of 2020 and intended to support a Phase II international trial for the efficacy of CBD as a treatment for acute myocarditis, this trial represents a major potential catalyst for the company’s stock in the coming months. Simultaneously, Cardiol anticipates the imminent launch of its pharmaceutical CBD product into the Canadian market in collaboration with Shoppers Drug Mart, representing a major commercial revenue opportunity for the company. Investors might want to keep an eye on Cardiol Therapeutics for more developments as the company tends to its several oars in the water.
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