There is a preponderance of evidence that cannabidiol, also known as CBD, has a number of potential health benefits. Studies have returned favorable results for CBD as a potential treatment for anxiety disorders (including post-traumatic stress disorder, obsessive-compulsive disorder, and social anxiety disorder), chronic pain, sleep disorders, high blood pressure, and more. The through line for almost all these studies? More rigorous research is needed to prove, in a clinical setting, that CBD actually delivers the results suggested by the preponderance of evidence. To date, GW Pharmaceuticals (acquired by Jazz Pharmaceuticals in 2021 for $7.2 billion, one of the largest biopharma acquisitions of the year) is the only company to cross the finish line, with its CBD drug Epidiolex® approved by the United States Food and Drug Administration for the treatment of two rare forms of childhood epilepsy.
Recently, Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) announced the start of its Phase II multi-center, international, 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. Cardiol also has received approval from the FDA to study CardiolRx™ in a Phase II multi-center open-label pilot study for the treatment of recurrent pericarditis and is currently completing a Phase II/III trial of CardiolRx™ for the treatment of COVID-19 patients with a history of, or risk factors for, cardiovascular disease. In short, Cardiol is doing just what the industry needs – studying CBD in a rigorous clinical setting to find out if the preclinical evidence pointing to heart health benefits can be proven true.
Help from the Orphan Drug Program
GW Pharma’s success in bringing CBD to market was aided immensely by its Epidiolex® being granted orphan drug status. Designed to spur development of drugs that treat conditions experienced by fewer than 200,000 U.S. citizens annually, the program is a major boon to researchers in their clinical trial programs. Incentives include seven-year marketing exclusivity, exemption from certain fees, and often accelerated regulatory review. Don’t let the small patient populations fool you into thinking there is little value in developing orphan drugs. Epidiolex® was the centerpiece of the $7.2 billion GW/Jazz deal, and the combined patient populations for the two indications in the U.S. are estimated in the neighborhood of just 33,000 people.
Cardiol is following the orphan drug playbook, with the U.S. patient population for acute myocarditis estimated at 73,000 people annually. The number of recurrent pericarditis (the other orphan indication Cardiol is investigating) patients in the U.S. is estimated to be 38,000 annually. There are a lot of variables and unknowns between the current stage of research and potential approval, but the opportunity is a large one. And in the greater picture of the potential for CBD as a scientifically proven medicine, Cardiol’s trial programs are pivotal.
Heart Health and CBD
There is a wealth of information pointing to CBD’s anti-inflammatory and anti-fibrotic properties, and there are studies that point specifically to the cardiovascular system as a target for CBD therapies. There are even studies that suggest CBD could be useful in treating chronic autoimmune myocarditis. Cardiol’s own preclinical work showed CBD to be specifically cardio-protective. Completed clinical trials are all that seem to be lacking in the arsenal of evidence.
Many of the world’s leading heart health experts have taken notice and have joined Cardiol’s efforts. The company has stacked its Scientific Advisory Board and its Steering Committee, responsible for designing and overseeing the trial, with a number of heart doctors from prominent institutions including the Mayo Clinic Enterprise Department of Cardiovascular Medicine, CardioVascular Research Center (CVRC) at the Tel Aviv Medical Center, Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital Boston, Harvard School of Medicine, and the Cleveland Clinic among many others.
Dennis McNamara, MD, MS, Professor of Medicine at the University of Pittsburgh, Director of the Center for Heart Failure Research at the University of Pittsburgh Medical Center, and Chair of the study steering committee commented, “We have long suspected that it is the response to injury that needs to be addressed to improve outcomes in myocarditis. Given its impact limiting these inflammatory mechanisms, we believe cannabidiol has the potential to truly benefit patients with this condition. I am pleased this important milestone has now been achieved and the ARCHER study, designed to investigate CardiolRx™’s therapeutic potential in myocarditis, is formally underway.”
With this potentially historic and groundbreaking study underway, Cardiol Therapeutics is traveling down a road that has not often been taken, but one that has been proven to be effective and lucrative. Clinical programs like Cardiol’s could pave the way for even more trials, by Cardiol and others, of CBD as a medicine while unlocking value for Cardiol shareholders with each advancement. Keep an eye out for further developments from this pioneering company.