Biotech stock Cardiol Therapeutics Inc. (TSX:CRDL | OTCQX:CRTPF | FSE:CT9) has enrolled its first patient in the LANCER trial. This is a Phase II/III Outcomes Trial evaluating high-risk patients hospitalized with Covid-19 who have a prior history of, or risk factors for, cardiovascular disease. Cardiol broke the news of its first participant in a press release dated April 28.
Dr. Andrew Hamer, Chief Medical Officer of Cardiol Therapeutics said:
“There is compelling evidence that inflammation plays a fundamental role in the development and progression of heart disease. I am excited to see the initiation of the LANCER trial which will provide a unique opportunity to explore the anti-inflammatory and cardioprotective properties of CardiolRx in COVID-19 patients who are at high risk for major cardiovascular complications.”
Helping fight the effects of Covid-19
The tragedy of Covid-19 continues to shroud the world in its devastating grip. Therefore, any chance of respite is warmly embraced. This trial by Cardiol Therapeutics hopes to prove that its proprietary drug CardiolRx has a protective effect in preventing cardiovascular complications in Covid-19 patients with pre-existing or risk factors for cardiovascular disease. These cardiovascular complications can include acute myocardial infarction, cardiac arrhythmias, myocarditis, stroke, and heart failure.
CardiolRx is an oral formulation containing cannabidiol (aka CBD), a chemical found in the cannabis sativa plant. The therapeutic and anti-inflammatory properties of cannabidiol are progressively being applauded.
CardiolRx is not Cardiol’s only CBD product. The company commercialized Cortalex, a pharmaceutically produced CBD formulation developed for the $575 million medicinal cannabidiol market in Canada.
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A randomized, double-bind study
The LANCER trial has been approved by the U.S. Food and Drug Administration (FDA). It will test the efficacy of CardiolRx in a Phase II/III stage in preventing cardiovascular complications in those participants. It’s a randomized, double-blind, placebo-controlled study.
In its full capacity it will assess the efficacy and safety of the drug in 422 hospitalized patients. Each of whom will have a confirmed diagnosis of Covid-19 in addition to pre-existing or significant risk factors of cardiovascular disease.
This study splits the patients into two groups; active and placebo. The outcomes being recorded during a 28-day-period include all-cause mortality, requirement for ICU admission and/or ventilatory support, along with cardiovascular complications. These further complications comprise the development of heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia.
The outcome of contracting Covid-19 varies from person to person. And no-one can predict how they’ll respond to the virus. That’s because it ranges from causing little to no symptoms, to severe symptoms, to death.
Severe complications such as bilateral pneumonia, or acute respiratory symptoms can be exacerbated by advanced age (over 64) or the prior presence of cardiovascular disease.
An exciting biotech growth stock
The company has a $148m market cap and its share price has risen 35% year-to-date. If CardiolRx proves to be successful in reducing severe cardiovascular symptoms in Covid-19 positive patients, it’s sure to have a major impact on the valuation of Cardiol Therapeutics.
That’s because any therapy that can limit the severity of this destructive disease is going to be in high demand. It would make an immensely positive difference to many lives, thereby proving the long-term viability of Cardiol Therapeutics as a strong investment.
Successful trial results may also lead to supporting a new drug application. In any case, it will provide the collation of invaluable clinical data providing insight into the therapeutic potential of CardiolRx.
Furthermore, chronic heart failure is understood to cost the U.S. healthcare system over $30 billion. Therefore, anything that reduces this burden is sure to be welcomed.
An independent committee of international experts in inflammatory heart disease is overseeing the LANCER trial. And it should be completed later this year. If CardiolRx proves effective, it’s likely to result in an emergency use authorization for the treatment of any Covid-19 patients who would have qualified for enrolment in the LANCER trial.
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