Company testing drug for COVID patients

Cardiol Therapeutics seeks to save the pandemic’s most vulnerable—those with pre-existing medical conditions and risk factors.

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Cardiol Therapeutics is testing a drug on hospitalized patients who have tested positive for COVID-19 and who have a prior history or risk factors for cardiovascular disease.

For most Canadians, a successful COVID-19 vaccination will put an end to the crisis that began last spring and, economic pain notwithstanding, open up the prospect of resuming a normal and healthy life after more than a year under varying degrees of restriction.

The vaccines offer hope for our country (and indeed the world at large) to achieve herd immunity and move past the pandemic. By now, the names of the companies producing doses have crossed the lips of nearly everyone in the world who can speak.

However, vaccination is an incomplete solution. Many individuals who were already infected will continue to wrestle with the effects of the coronavirus, as well as related complications, indefinitely, the most vulnerable being those with pre-existing medical conditions and risk factors.

Treatment for those most at risk

Cardiol Therapeutics Inc. (TSX—CRDL) is a Canadian company working on suitable treatments for this population.

The Oakville, Ont.-headquartered biotechnology company is testing the use of its proprietary CardiolRx cannabidiol (CBD) formulation on hospitalized patients who have tested positive with COVID-19 and have either a prior history of or risk factors for cardiovascular disease.

(Such risk factors include having diabetes, hypertension, obesity, abnormal serum lipids or being over the age of 64.)

Company president and CEO David Elsley told Investor’s Digest in a telephone interview, “We could see this drug available through emergency-use applications” by the second half of this year, with broader availability following US FDA approval thereafter. He stresses that people who have had cardiovascular problems in the past or risk factors are at the greatest risk of suffering serious consequences from COVID-19 and likelier to get sick in the first place.

“Moreover, such COVID-19 patients are at significant risk of developing cardiovascular complications (such as stroke and heart failure) during the course of their illness, which are frequently fatal,” a statement on Cardiol Therapeutics’ website adds. They required more medical resources as well, such as ventilators.

Clinical trials underway in USA

CardiolRx is an oral acute anti-inflammatory treatment; research has shown CBD’s usefulness in controlling inflammatory heart disease.

Cardiol Therapeutics is in the midst of a Phase 2/3 clinical trial of 422 hospitalized COVID-19 patients in the United States fitting the criteria noted above, set to finish in mid-2021.

In the multi-site, double-blind, placebo-controlled trial, the company will measure the effectiveness of CardiolRx according to how many patients do not develop cardiovascular complications and avoid the intensive care unit.

Whereas the pandemic shuttered many businesses from the outset and have since forced many to close permanently, Mr. Elsley says it did not present any setbacks for his company given its health-care focus.

“Everything actually went to plan and it actually went a little bit ahead of plan.”

“Our whole supply chain are essential services. Our drug is being used on the front lines to protect high-risk cardiac patients.”

Drug may also have other uses

Aside from CardiolRx’s use in COVID patients, it is exploring its potential in preventing acute myocarditis, the top cause of sudden cardiac death (generally linked to flu viruses) in young people (35 years old and under).

In both composition and orphan application, CardiolRx is comparable to GW Pharmaceuticals PLC’s (NASDAQ—GWPH) lead product, Epidiolex, also a CBD oral solution but used to treat seizures caused by rare diseases that lead to severe pediatric epilepsy. Last February, GW announced that it will be bought for total consideration of US$7.2 billion by Jazz Pharmaceuticals PLC (NASDAQ—JAZZ), in a deal slated to close sometime in the second quarter.

That said, the potential pool of patients is considerably larger in the case of acute myocarditis than pediatric epilepsy. In the United States, there are an estimated 73,000 patients with acute myocarditis, compared to 37,250 patients with pediatric epilepsy.

Cardiol Therapeutics announced initial results from a Phase 1 trial in preparation of a Phase 2 trial for an acute myocarditis application. The trial found that there were no serious adverse side effects from CardiolRx in patients and was generally safe and well-tolerated at all dose levels.

Company seeking NASDAQ listing

On March 2, the company announced it had filed for a NASDAQ listing with the intent of increasing its visibility to investors in the United States and abroad.

Cardiol plans to graduate to the tech-oriented exchange sometime in the second quarter of 2021. Although Mr. Elsley did not provide an exact date, he indicated in early April that the filing had not run into any hiccups yet.

“We don’t fully control the process but we fully expect to be approved,” he said.

In the meantime, he expressed confidence that the company is well-capitalized and able to afford running all of its major programs.

Robin Poon is editor of Investor’s Digest of Canada.

This is an edited version of an article that was originally published for subscribers in the May 7, 2021, issue of Investor’s Digest of Canada. You can profit from the award-winning advice subscribers receive regularly in Investor’s Digest of Canada.

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