Sponsored // 7 Min Read

When Your Heart Cannot Pump Enough Blood
And Oxygen, It’s A Life-Threatening Condition.

As Medical Science Expands In Leaps And Bounds, One Company Aims To Combat Heart Failure In A Unique, Game-Changing Way.

Welcome to Cardiol Therapeutics, a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease.

4 Key Potential Milestones That Could Prove Cardiol Therapeutics’ Stock To Be Undervalued At Current Levels (4)

It’s coming for us all. There’s no doubt about it. Mortality is a real thing.

No matter how much we deny it, time is not on our side. But, how each of us arrive at that final destination remains to be seen.

That said, it would appear that in the United States, one major factor is putting the proverbial “nail in the coffin” for many Americans: heart disease.

According to the CDC, heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. (1)

In fact, the CDC shares: (1)

Fortunately for us all, one small under-the-radar company, Cardiol Therapeutics (Nasdaq:CRDL) (TSX:CRDL), is making tremendous progress on anti-inflammatory therapies for the treatment of cardiovascular disease.

And there might not be more of an important time than right now for Cardiol Therapeutics.

To The Rescue Comes Cardiol Therapeutics’ Lead Dr-ug Candidate: CardiolRx™(3)

CardiolRx™ is an oral cann-a-bidiol formulation being developed for the treatment of acute inflammatory heart disease. It is pharmaceutically produced under cGMP to meet the highest standards for product purity, consistency, and stability.
Source 3

How Cann-a-bidiol Protects the Heart in Models of Cardiovascular Disease

There is strong evidence supporting therapeutic potential in acute and chronic inflammatory heart disease.

Check it out:

Source 3
Could cann-a-bidiol be the key ingredient to solve issues revolving around heart inflammation?

Two Of Our Main Protagonists: CV-19 and CVD (2)

We’ve been under fire from a health crisis worldwide like we’ve never experienced in our lives. With CV-19 running rampant the last few years, it has put people with pre-existing health conditions in harm’s way.

It has been found that CV-19 is much more severe for those with cardiovascular disease (CVD) than for those without CVD. It’s estimated that 30 – 40% of patients who die from CV-19 do so from cardiovascular complications.

CV-19, a disease caused by the severe acute respiratory syndrome c-virus 2, is considered primarily a respiratory disease. However, an increasing number of reports indicate that CV-19 patients are at higher risk of developing cardiovascular complications, and CV-19 is found to be more deadly for those with cardiovascular disease (CVD) than for those without CVD.

Patients with CV-19 present primarily with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of CV-19 is not limited to the lungs. Individuals with pre-existing CVD or who have risk factors for CVD (such as diabetes, hypertension, obesity, abnormal serum lipids, or age greater than 64) are at significantly greater risk of developing serious disease from CV-19 and experience greater morbidity.

Moreover, such CV-19 patients are at significant risk of developing cardiovascular complications (such as acute myocardial infarction, cardiac arrhythmias, myocarditis, stroke, and heart failure) during the course of their illness, which are frequently fatal. A strategy to prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes from this disease.

The rationale for the clinical program of cann-a-bidiol as a therapeutic approach to the treatment of CV-19 is based upon the reported anti-inflammatory effect of cann-a-bidiol. In addition, cann-a-bidiol has a cardio-protective effect and, therefore, it is anticipated that this cann-a-binoid may prevent CV-19-related cardiovascular complications thereby reducing morbidity and mortality.

Huge Potential Catalyst For Cardiol Therapeutics’: The LANCER Trial (4)

The company has received clearance from the U.S. Food and Dr-ug Administration for its Investigational New Dr-ug application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of its lead product, CardiolRx™.

The “LANCER Trial” Phase II/III Trial is designed to investigate the cardiorespiratory protective properties of CardiolRx™ in patients hospitalized with CV-19 who have a prior history of, or risk factors for, cardiovascular disease.

Primary Efficacy Endpoints*:

* Experience one of the following events during the first 28 days

Secondary Efficacy Endpoints: 

422 Patients will be randomized 211 to CardiolRx™, 211 to placebo.

International Trial: U.S., Brazil, and Mexico clinical sites enrolling patients: clinical trial site initiation pending in Canada.

Treatment Oral Administration: Starting at 5mg/kg of body weight/day to a maximum of 15 mg/kg/day administered twice daily with food for 28 days.

Phase II/III LANCER Study Design

Source 3

Just imagine if this dr-ug candidate/study receives highly positive results?

Those results could be game-changing for Cardiol Therapeutics (Nasdaq:CRDL) (TSX:CRDL).

Another Major Cardiol Therapeutics’ Focus: Acute Myocarditas (5)

Acute myocarditis is a significant cause of acute heart failure and death in younger individuals and remains a leading cause of sudden cardiac death in people under 35 years of age.

The most recent data from the ‘Global Burden of Disease Study’ suggests that the prevalence of myocarditis is approximately 22 per 100,000 population. In the United States, an orphan dr-ug designation is granted for pharmaceuticals being developed to treat medical conditions affecting fewer than 200,000 people. These conditions are referred to as orphan diseases. The assignment of orphan status to a disease and to dr-ugs developed to treat it is a matter of public policy in many countries and has yielded medical breakthroughs that might not otherwise have been achieved. 

In the U.S. and the European Union, orphan dr-ugs are eligible for accelerated marketing approvals and companies developing orphan dr-ugs typically receive other incentives, including a prolonged period of market exclusivity that can extend over seven years, during which the dr-ug developer has sole rights to market the dr-ug.

Acute myocarditis is characterized by inflammation in the heart muscle (myocardium). It has many causes, but the most common is a viral infection. In most patients the immune system is effective in clearing the virus in five to seven days, inflammation subsides, and the individual makes a full recovery. In a proportion of patients, however, the inflammation in the heart persists – perhaps as an auto-immune process – and causes decreased heart function with symptoms and signs of heart failure. In some cases, this becomes progressive and leads to a chronic dilated cardiomyopathy which is the most common reason for heart transplantation.

Since people with acute myocarditis have impaired heart function, treatment is based on standard-of-care recommendations for heart failure. This includes diuretics, ACE inhibitors, angiotensin receptors blockers, beta blockers, and aldosterone inhibitors. For those with a severe and sudden onset presentation, intensive care is often required, with the use of inotropic medications (to increase the force of the heart muscle contraction) and occasionally, heart-lung bypass or ventricular assist devices. There is otherwise no specific treatment for acute myocarditis although some patients have responded to immuno-suppressive therapy (azathioprine) in combination with steroids, but the data are not conclusive enough for this to be the recommended therapy.

Based on the large body of experimental evidence of the anti-inflammatory activity of cann-a-bidiol in models of cardiovascular disease, Cardiol believes there is a significant opportunity to develop CardiolRx™ as a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an orphan dr-ug. CardiolRx™ is a pharmaceutical cann-a-bidiol formulation that is manufactured under cGMP, and the same concentration (100mg/mL CB-D) as the first FDA-approved cann-a-bidiol therapy for use as an orphan dr-ug in rare forms of pediatric epilepsy.

Cann-a-bidiol Attenuates Myocarditis-induced Fibrosis (4)

Cann-a-bidiol Attenuates Myocarditis-induced Fibrosis (4)

Experimental Model of Autoimmune Myocarditis (EAM)

Source 3

CardiolRx™ – Acute Myocarditis Clinical Development (4)

Cardiol Therapeutics Inc. IND application cleared by FDA for global Phase II trial.

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.

Three co-primary Endpoints*:

*Difference in means between active and placebo during the first 12 weeks

Secondary Endpoints:

100 Patients will be randomized 50 to CardiolRx™, 50 to placebo.

Anticipate 25-30 sites U.S., Canada, and Europe. (Regulatory authorization to be obtained)

Treatment starting at 5mg/kg of body weight/day to a maximum of 20 mg/kg/day administered twice daily with food

Acute Myocarditis Study Design

Source 3
Between CV-19 CVD and the Myocarditis studies alone, CardiolRx™ could soon become a groundbreaking treatment.

But What About Straight Up Heart Failure? Cardiol Therapeutics Could Offer Significant Help Too (6)

Chronic Heart Failure (HF) is no joke. 

Here’s a couple scary details to chew on: (4)

Heart failure occurs when the heart is no longer able to pump blood sufficient for the body’s needs. People with HF suffer from shortness of breath, rapid heart rate, edema, reduced exercise capacity, and often struggle with simple daily activities. They are frequently hospitalized and for many, these symptoms significantly reduce quality of life.
Source 6
Source 6
There have been no significant treatment advances in HFpEF in the past 20 years; the primary therapy remains diuretics. Cardiol is dedicated to improving patients’ outcomes with innovative formulations that target inflammation and fibrosis in the heart.

Subcutaneous Cann-a-bidiol Formulation

Cardiol is developing a proprietary subcutaneous formulation of cann-a-bidiol to achieve higher bioavailability. This subcutaneous formulation would be a new approach to the treatment of chronic heart failure based on the anti-inflammatory activity of cann-a-bidiol to treat inflamed heart tissue and the anti-fibrotic activity of cann-a-bidiol to treat fibrosis (scarring) in heart muscle.

Published third-party research has shown that cann-a-bidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cann-a-bidiol has also been shown to attenuate a number of measures of inflammation in models of diabetes, a common co-morbidity in heart failure patients, and to reduce myocardial fibrosis in a model of inflammatory heart disease. 

Cardiol’s subcutaneous administration of cann-a-bidiol is designed to avoid first-pass metabolism, optimize and maintain blood levels of the dr-ug, and target inflammation and increased fibrosis in the heart. Cardiol believes that by enhancing the bioavailability will significantly broaden the therapeutic potential of this molecule.

Cardiol’s research shows cann-a-bidiol reduces the development of angiotensin-induced fibrosis: histopathologic analysis of heart tissue.

Source 6
In case you lost count, heart failure gives Cardiol Therapeutics (Nasdaq:CRDL) (TSX:CRDL) a third main area of focus in which its lead dr-ug candidate CardiolRx™ could help shape the future.

Cardiol Therapeutics’ Pipeline (6)

Source 4

4 Key Potential Milestones That Could Prove Cardiol Therapeutics’ Stock To Be Undervalued At Current Levels (4)

Take a moment now and get Cardiol Therapeutics (Nasdaq:CRDL) (TSX:CRDL) on your radar before it’s too late.

Source 1: https://www.cdc.gov/heartdisease/facts.htm

Source 2: https://www.cardiolrx.com/our-focus/co-vid-19/

Source 3: https://www.cardiolrx.com/cardiolrx/cardiolrx-c-b-d/

Source 4: https://www.cardiolrx.com/wp-content/uploads/2022/02/Cardiol-Therapeutics-Corporate-Presentation-February-2022.pdf

Source 5: https://www.cardiolrx.com/our-focus/acute-myocarditis/

Source 6: https://www.cardiolrx.com/our-focus/heart-failure/

Company Information

2265 Upper Middle Road East Suite 602 Oakville, ON L6H 0G5 Canada 289 910 0850 https://www.cardiolrx.com

Cardiol Therapeutics Inc., a clinical-stage biotechnology company, focuses on the research and development of anti-inflammatory therapies for the treatment of cardiovascular disease (CVD). Its lead product is CardiolRx, an ultra-pure and high concentration cannabidiol oral formulation for the treatment of in hospitalized COVID-19 patients with a prior history of risk factors for CVD; and has completed phase I clinical trials for the treatment of acute myocarditis and other inflammatory heart disease. The company is also developing a proprietary subcutaneous formulation of cannabidiol to achieve higher bioavailability for the treatment chronic heart failure.