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Cardiol gets FDA nod for IND application for Phase II/III COVID-19 trial of lead drug CardiolRx

The trial at major US centers will evaluate the cardioprotective properties of CardiolRx in patients hospitalized with COVID-19, who have a history of cardiovascular disease

Cardiol Therapeutics - Cardiol gets FDA nod for IND application for Phase II/III COVID-19 trial of lead drug CardiolRx
Cardiol Therapeutics CEO David Elsley described the FDA approval to initiate a clinical program as “a major milestone” to “significantly accelerate” the commercial development of CardiolRx

Cardiol Therapeutics Inc (TSE:CRDL) (OTCQX:CRTPF) revealed on Friday that the US Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to start a Phase II/III coronavirus (COVID-19) clinical study of its lead drug CardiolRx, an extra strength formulation of pharmaceutical cannabidiol.

The Oakville, Ontario-based company focused on developing innovative therapies for heart disease, said the double-blind, placebo-controlled clinical trial would study the potential and safety of CardiolRx in 422 hospitalized COVID-19 patients with a history of, or risk factors for, cardiovascular disease (CVD). The trial will take place at major US centers, said the company.

Investors responded well, sending Cardiol's stock 21% higher in Toronto to C$3.04 each, and more than 23% higher in New York to US$2.30.

Cardiol said that it is now recognized that the impact of COVID-19 is not limited to the pulmonary system. Individuals with pre-existing CVD, or people who have risk factors for CVD (such as diabetes, hypertension, obesity, abnormal serum lipids, or are older than 64) are at “significantly greater risk” of developing serious disease from COVID-19.

READ: Cardiol Therapeutics initiates Health Canada approved Phase 1 clinical study of lead drug CardiolRx

Moreover, such COVID-19 patients are again at “significant risk” of developing CVD complications (such as acute myocardial infarction, cardiac arrhythmias, myocarditis, stroke, and heart failure) during their illness. An estimated 30-to-40% of patients who die from COVID-19 actually do so from cardiovascular complications. A strategy to “prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes,” said the company.

Cardiol's Phase II/III trial will assess the effectiveness, safety, and tolerability of CardiolRx in preventing cardiovascular complications in hospitalized patients with COVID-19 within the previous 24 hours who have pre-existing CVD or are at risk for the same. The primary endpoint will track the difference between the active and placebo groups and weigh the percentage of patients who develop, during the first 28 days following randomization and first dose of study medication, one or more of several common outcomes, including “all-cause mortality, requirement for ICU admission and/or ventilatory support,” as well as cardiovascular complications, including the “development of heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia.”

The study was designed and will be overseen by an independent Steering Committee of heart disease experts including Dr Dennis McNamara (chair), who is the Professor of Medicine and Director of the Center for Heart Failure Research, in the University of Pittsburgh, and Dr Leslie Cooper (co-chair), who is the chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine.

In a statement, Dr Dennis McNamara, chair of the Steering Committee for the trial said: "As a Steering Committee, we are excited about the potential for this study to contribute valuable new information about the role of anti-inflammatory agents in the management of COVID-19.”

He added: “Now that approval from the FDA has been granted, we are anxious to get underway so that we can investigate the impact of CardiolRx in this very important disease process."

Cardiol Therapeutics CEO David Elsley described the FDA approval to initiate a clinical program as “a major milestone” to “significantly accelerate” the commercial development of CardiolRx.

"The COVID-19 pandemic is providing our company with a unique opportunity to rapidly study the cardioprotective properties of CardiolRx in patients who have a prior history of, or risk factors for, cardiovascular disease and are most vulnerable to the virus,” added Elsley.

“Subject to study outcomes, our discussions with the FDA indicated that the design and scope of our Phase II/III trial may be used as a registration study in support of a New Drug Application."

The rationale for using cannabidiol to treat patients with COVID-19 is based on pre-clinical investigations by Cardiol and others in models of cardiovascular inflammation which have demonstrated that CBD has impressive anti-inflammatory and anti-fibrotic powers, and that “it improves myocardial function in models of heart failure.” In pre-clinical models of cardiac injury, CBD was shown to be cardio-protective by reducing cardiac hypertrophy, fibrosis, and the production of certain re-modelling markers, such as cardiac B-type Natriuretic Peptide (BNP), which is typically elevated in patients with heart failure.

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

-- Updates with stock activity -- 

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