Cannabidiol Phase 1 Clinical Trial Launches, Targeting Inflammatory Heart Condition --

Redondo Beach, California--(Newsfile Corp. - September 16, 2020) -, a leading financial news and information portal offering free real time public company filing alerts, announces the publication of an article covering Cardiol Therapeutics Inc.'s (TSX: CRDL) (OTCQX: CRTPF) initiation of a Phase 1 clinical study, intended to assess the safety, tolerability, and pharmacokinetics of its proprietary cannabidiol (CBD) formulation, CardiolRx™. The results of this study will inform Cardiol's planned Phase 2 international trial of CardiolRx™ for the treatment of acute myocarditis, an inflammatory heart condition. The phase 2 trial is being designed in conjunction with heart experts from leading medical centers in the U.S., Canada, and Germany. Rigorous clinical trials are the only way to drug approval, and Cardiol is hopeful that the abundance of laboratory evidence demonstrating CBD's anti-inflammatory properties translates into clinical proof of efficacy in treating acute myocarditis.

CBD is thought to be beneficial for a wide variety of ailments, ranging from poor sleep to pain to PTSD and beyond. To this point, however, there haven't been many clinical trials conducted to thoroughly prove or disprove the benefits of CBD. So far, it has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of two rare forms of epilepsy in children, as well as for seizures associated with tuberous sclerosis complex. The approved CBD formulation is Epidiolex®, produced and marketed by GW Pharmaceuticals.

Acute Myocarditis Caused by Viral Infections, Including COVID-19

Cardiol is looking to follow the path blazed by GW Pharma in utilizing the FDA's Orphan Drug Designation, a program designed to encourage and fast-track development of drugs for the treatment of rare diseases. Acute myocarditis is thought to affect around 70,000 Americans, fitting nicely under the Orphan Drug cap of 200,000 afflicted citizens, and about double the U.S. patient population represented by GW's treatment for rare childhood epilepsies (Lennox-Gastaut and Dravet Syndromes).

Acute myocarditis is inflammation of the heart muscle, and it most often results from a viral illness such as Coxsackie B, HIV, adenovirus, and hepatitis C. Currently the disease is not easily treatable, if at all, with supportive management of symptoms through the use of steroids being the most common course of action. It is more common in younger adults and can lead to sudden cardiac death in the most severe cases.

As more information is gathered on the effects of the COVID-19 viral infection, it is becoming apparent that a significant number of COVID-19 patients have markers of heart damage consistent with myocarditis, even among those patients demonstrating mild or no symptoms upon diagnosis. Cardiol, already deep into its CBD/heart research, noticed the connection and filed in May for an international patent covering the use of CBD to improve outcomes for COVID-19 patients. The company plans to initiate a clinical program later this year to investigate the potential benefits of CBD in these cases.

CBD as a Drug

Quality control, standardization, and cost effectiveness are among the hurdles facing drug development companies working with plant-based active ingredients. Deriving pure, consistent active ingredients from various batches of plants is difficult and expensive and can be hard to scale when dealing with most any plant. With cannabis, there is the added layer of the plant's illegal and psychoactive nature. Supply can be constrained, and contaminants like pesticides are often used in producing the crop at scale.

As with historic plant-based drugs like aspirin (from Willow and other species), and the more recent Taxol (from the Pacific Yew), these issues often lead researchers and companies to develop a synthetic or semi-synthetic version of the active ingredient. Cannabis-derived actives are no different.

Cardiol has created, in conjunction with Dalton Pharma Services, its own pharmaceutical CBD product, CardiolRx™. Produced in cGMP and FDA-approved facilities, CardiolRx™ provides consistency and purity in every batch, without the attendant concerns of plant-derived extracts. Production can be scaled without supply chain and quality issues that can make agricultural production difficult. It is an elegant solution to the issues surrounding cannabis-based drug development.

What's Ahead

As Cardiol Therapeutics conducts its Phase 1 trial, expected to wrap up later this year, the company has a few other irons in the fire. Cardiol is anticipating the imminent launch of a consumer version of its CBD formulation to the medical cannabis market in Canada. Production (with Dalton Pharma) and distribution (with Medical Cannabis by Shoppers Drug Mart) have already been worked out. The company believes it will be the first CBD formulation available in the market that is free of THC (<10 ppm THC), the psychoactive ingredient of cannabis. This feature could be important for patients who want to steer completely clear of any risk of THC interaction.

Cardiol also has two other clinical pathways to explore. There is the aforementioned COVID-19/heart inflammation/CBD trial, as well as a program to investigate CBD as a treatment for heart failure. The company has chosen to focus on acute myocarditis initially, due in large part to the advantages (time and expense) of potential Orphan Drug development. Keep an eye out in the coming months as Cardiol continues to bring its rigorous scientific approach to the world of cannabinoid drug development.

Interested parties are encouraged to listen to Cardiol Therapeutics' recent presentation at the H.C. Wainwright Virtual 22nd Annual Global Investment Conference here. Other recent presentations can be found on Cardiol's website here.

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