- 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
- Recently launched Cortalex through a national agreement with Medical Cannabis by Shoppers to retail Cortalex on an exclusive basis across Canada
What Cardiol Therapeutics does:
The Canadian specialty pharmaceutical company has developed a proprietary formula of ultra-pure pharmaceutical cannabidiol (CBD) that does not contain THC - less than 5 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.
While advancing important clinical trials in inflammatory heart disease, Cardiol is generating a near-term revenue opportunity in the growing Canadian medical cannabinoid market, currently exceeding $600 million annually, with its recently launched commercial product, Cortalex, the first THC-free extra-strength formulation of cannabidiol oil available across Canada exclusively online at Medical Cannabis by Shoppers.
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 into 2021.
How is it doing:
Cardiol’s Phase 1 clinical study of CardiolRx is on schedule to be completed during Q4, 2020, and is believed to represent the first Health Canada approved study of a high concentration (100 mg/mL) cannabidiol formulation that contains virtually no THC. By measuring standard safety parameters and the pharmacokinetics of CardiolRx, including the degree of drug absorption and resulting blood levels at escalating doses, the Phase 1 study will provide important information to optimize dosing levels for the company’s planned Phase 2 international trial in acute myocarditis.
In September, the US FDA approved the company’s Investigational New Drug (IND) application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of CardiolRx, a pharmaceutically produced extra-strength cannabidiol formulation, in 422 hospitalized coronavirus (COVID-19) patients with a prior history of, or risk factors for, cardiovascular disease (CVD). The trial will take place at major centers in the United States, where the prevalence of COVID-19 remains high.
Cardiol is planning a Phase II international trial of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age.
The firm took a major step in its commercialization process by inking a national deal with Medical Cannabis by Shoppers, a subsidiary of Canada’s largest pharmacy chain, Shoppers Drug Mart Inc, to become the exclusive retailer of Cortalex products in Canada.
Under the terms of the agreement, Cardiol's exclusive pharmaceutical partner, Dalton Pharma, is supplying Cardiol's pharmaceutical cannabidiol products to Shoppers for resale in all provinces and territories in Canada through Shoppers' online store. Shoppers also has the right to resell all future products available from Cardiol's product line, subject to any and all regulations.
- Commercial introduction of Cortalex across Canada through national supplier agreement with Medical Cannabis by Shoppers
- Commencement of Cardiol’s 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
- Commencement of Phase II international trial of CardiolRx in acute myocarditis
What the boss says:
Cardiol is well-positioned to execute on its strategy to address “significant opportunities” in healthcare, according to the company's CEO David Elsley.
“Receiving approval from the FDA for our IND application to initiate a clinical program in COVID-19 patients represents a major milestone for Cardiol Therapeutics and provides the opportunity to significantly accelerate the commercial development of CardiolRx,” Elsley, said recently.
“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. 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.”
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