In recent years public and medical interest in cannabidiol (CBD) has been rising. It’s widely believed the untapped powers of CBD are plentiful, and there’s a push to prove this from a scientific point of view.
One company pioneering this quest is Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL), a clinical-stage life sciences company. Cardiol is intensely focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for treating cardiovascular diseases (CVD).
Cardiol Therapeutics is developing CardiolRx™, a pharmaceutically produced oral cannabidiol formulation to potentially treat acute and chronic inflammation associated with heart disease.
First Acute Myocarditis Patient Enrolled in ARCHER Trial
The Company is excited to announce the first patient has enrolled in ARCHER, its Phase II trial designed to study the safety and tolerance of CardiolRx™ in patients presenting with acute myocarditis. The trial will also test the drug’s impact on myocardial recovery.
This multi-center, international, Phase II trial is double-blind, randomized, and placebo-controlled.
What is Acute Myocarditis?
Acute myocarditis is a significant cause of acute and fulminant heart failure in young adults and is a leading cause of sudden cardiac death in people less than 35 years of age.
Cardiol’s acute myocarditis trial is expected to enroll 100 patients at major cardiac centers throughout the North America, Europe, Latin America, and Israel.
The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of two cardiac magnetic resonance measures that have been shown to predict the long-term prognosis of patients with acute myocarditis.
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.”
Causes of Acute Myocarditis
Although viral infection is the most common cause of myocarditis, the condition can also result from cancer treatment therapies. Myocarditis has also been described as a complication of COVID-19 and, more recently, has been reported as a rare complication associated with certain vaccines for COVID-19.
Although acute myocarditis should be managed with guideline-directed therapies for heart failure, arrhythmia and conduction disturbances, there is no uniformly accepted treatment for the underlying inflammatory processes associated with this condition.
Additionally, Cardiol Therapeutics has a multi-national clinical study underway evaluating the efficacy and safety of CardiolRx™ as a cardioprotective therapy in treating COVID-19 patients with a prior history of, or risk factors for, CVD. Cardiol is also undertaking a Phase II multicenter open-label pilot study in recurrent pericarditis.
Furthermore, Cardiol is developing a subcutaneous formulation of cannabidiol for treating inflammation and fibrosis associated with the development and progression of heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the U.S. exceeding $30 billion annually.