- Proprietary formulation produces ultra-pure pharmaceutical cannabidiol (CBD) without the psychotropic effects of THC for the treatment of inflammatory heart disease
- Received US FDA approval to commence a Phase II/III COVID-19 trial investigating the cardioprotective properties of CardiolRx
- Investigational New Drug (IND) application cleared by the FDA for a Phase II international trial assessing the safety and tolerability of CardiolRx, as well as its impact on myocardial recovery in patients presenting with acute myocarditis
What Cardiol Therapeutics does:
Cardiol Therapeutics Inc (TSE:CRDL) (OTCQX:CRTPF) is a clinical-stage biotechnology company focused on developing innovative therapies for inflammatory heart disease.
The Canadian specialty pharmaceutical company has developed a proprietary formula of ultra-pure pharmaceutical cannabidiol (CBD) that does not contain THC - less than 10 parts per million (ppm) - and consequently none of the psychotropic effects of THC.
Its flagship product, CardiolRx, is formulated to be one of the safest and most consistent CBD medicines available on the market. CardiolRx has been developed and manufactured to the highest standards of cGMP to ensure consistency, stability, and purity in every dose.
Cardiol is also developing a proprietary subcutaneous formulation to uniquely deliver pharmaceutical cannabidiol to sites of inflammation in the heart associated with heart failure, a major healthcare burden in North America, costing the US healthcare system over US$30 billion a year.
With all the pieces in place to commercialize its THC-free cannabidiol formulation and an international research program focused on advancing its product pipeline for the treatment of heart failure, the company is positioned for significant growth.
How is it doing:
Cardiol has been making good progress so far in 2021.
On April 28, the company announced that the first patient had been randomized in the LANCER Phase II/III trial of its oral cannabidiol formulation CardiolRx. The trial is a randomized, double-blind, placebo-controlled study that will test the efficacy and safety of CardiolRx in preventing cardiovascular complications in 422 hospitalized patients who have a confirmed coronavirus (COVID-19) diagnosis and pre-existing (or at risk for) cardiovascular disease.
LANCER is being run in major hospitals across the US. The study’s primary endpoint will be the difference between the active and placebo groups in the percentage of patients who develop one or more outcomes – cardiovascular complications, ICU admission rates, ventilatory support – during the first 28 days following randomization and the first dose of study medication.
The trial is expected to be completed during 2021 and will support an emergency use authorization for the treatment of COVID-19 patients who would have qualified for enrollment in LANCER, according to Cardiol, which added that successful trial results may also be used to support a new drug application. LANCER should also generate “invaluable” clinical data about the potential of CardiolRx to treat of other cardiac inflammatory disorders, including acute myocarditis and heart failure, the company added.
On April 12, Cardiol announced topline results from its Phase I clinical trial of CardiolRx. The company said the results from the single and multiple ascending dose trial indicate that the drug was safe and well-tolerated at all dose levels, with no serious side effects reported. As well, pharmacokinetic studies determined that blood levels of the drug tended to rise hand-in-hand with an increasing dose.
In August 2021, the company announced that the U.S. Food and Drug Administration (FDA) provided clearance to proceed with the Company’s Investigational New Drug (IND) application to commence a Phase II, multi-center, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery in patients presenting with acute myocarditis. The study is expected to enroll 100 patients at clinical centers in the United States and Europe.
CardiolRx is being developed to treat acute and chronic inflammation associated with heart disease. Currently, the treatment is being studied as a cardioprotective therapy to reduce mortality and major cardiovascular events in coronavirus (COVID-19) patients, who have a prior history of, or risk factors for, cardiovascular disorder.
In January, the company had announced the formation of two committees for its Phase II/III trial examining the efficacy of CardiolRx in high-risk coronavirus (COVID-19) patients. Cardiol said that the Data Safety Monitoring Committee (DSMC) and the Clinical Endpoint Committee (CEC) would be involved in the ongoing trial, which looks at 422 patients hospitalized with COVID-19 at clinics throughout the US.
On the personnel front, at the end of March, Cardiol bolstered its executive team with the addition of Dr. Andrew Hamer as its chief medical officer. Hamer has 30 years of experience in the global life sciences industry, medical affairs, and cardiology. He most recently served as Executive Director, Global Development-Cardiometabolic at Amgen Inc, where he led the global development of Repatha, a LDL cholesterol-lowering PCSK9 inhibitor evolocumab with around $900 million in sales last year.
Looking at financials, on April 1, Cardiol revealed that it had capped off a busy 2020 with a strengthened cash balance of C$14 million. The pharmaceutical firm had a busy 4Q 2020, having completed the Phase 1 study of CardiolRx.
Adding to that financial strength, on May 12, Cardiol closed a previously announced offering of units of the company for aggregate gross proceeds of approximately $22 million. The deal was upsized from its original $15 million offering due to strong demand. Cardiol said it is planning to use the proceeds to advance research and clinical development programs, for additional commercial product development, and for general corporate purposes.
And on March 2 the company said it had received proceeds of over $10 million from the exercise of warrants and stock options. In August, the Company’s shares were listed on the NASDAQ, the premier global stock exchange for life science and biotechnology companies.
Inflection points:
- Commencement of LANCER, a Phase II/III trial investigating its lead product, CardiolRx, in hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease
- Completion of Health Canada approved Phase 1 study
- IND application cleared for Phase II international trial of CardiolRx in acute myocarditis
- Common shares listed on NASDAQ capital markets
What the broker says:
On March 25, 2021, Leede Jones Gable initiated coverage on Cardiol with a ‘Speculative Buy’ rating.
In a note to clients, the research firm's analyst, Douglas Loe cited Cardiol’s revenue potential from its ultrapure cannabidiol formulation Cortalex, which was launched last year through the Medical Cannabis by Shoppers portal.
Loe said: “Cannabidiol’s clinical prospects in cardiovascular disease are, perhaps surprisingly at least to us initially, quite well-documented in the medical literature in preclinical models of disease nd our diligence thus suggests to us that Cardiol’s initiative to more fully test cannabidiol’s clinical prospects is justified and with strong prospects for value creation based on future Phase II/III efficacy signals that we expect to transpire during our forecast period."
“What we found most striking in our investigation of cannabidiol’s medical prospects in cardiovascular disease was just how well-characterized its prospects actually were in this disease category, despite which few if any firms other than Cardiol are exploring this activity,” he added.
The analyst cited a number of diseases that could potentially be treated with Cortalex, including coronavirus-associated cardiovascular disease, acute myocarditis and diastolic heart failure. He also noted that Cardiol’s strategic manufacturing alliance for CardiolRx with Purisys and Dalton Pharma Services provides competitive advantages in medical markets where cannabidiol purity is critical to clinical success.
What the boss says:
Commenting on its IND approval in August, CEO David Elsley said: "IND clearance to proceed with our Phase II clinical trial of CardiolRx in patients with acute myocarditis represents another major milestone for Cardiol as we continue to pursue the development of new treatment options for patients with inflammatory heart disease."
Elsley added: "We look forward to further studying the cardioprotective potential of CardiolRx in this rare but potentially devastating condition that remains an underdiagnosed cause of acute heart failure, sudden death, and chronic dilated cardiomyopathy."
Contact Angela at angela@proactiveinvestors.com
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