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Cardiol Therapeutics Inc, a Toronto-based clinical-stage life sciences company developing anti-inflammatory and anti-fibrotic therapies for heart disease, announced that it has received a notice of allowance for the company’s US patent application entitled “Cannabidiol Compositions for Use in Treating Heart Conditions” from the United States Patent and Trademark Office.
Once if it’s issued, the new patent will establish broad intellectual property (IP) protection for the use of CardiolRx and CRD-38 in the treatment or prevention of an extensive range of cardiac conditions, including heart failure, myocarditis, acute pericarditis, inflammatory cardiomyopathy, cardiac toxicity from anti-cancer therapies, and atherosclerosis, up to October 2040.
Cardiol Therapeutics’ lead small molecule drug candidate, CardiolRx (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease.
“This important milestone extends our IP protection to the world’s largest pharmaceutical market,” said David Elsley, President and CEO of Cardiol Therapeutics. “Together with our US Orphan Drug Designation for pericarditis, this new patent allowance fortifies Cardiol’s market position and IP portfolio, providing broad protection across a diverse range of heart diseases characterized by inflammation and fibrosis. This expanded exclusivity coverage also reinforces the long-term value of our pipeline as we advance late-stage clinical programs in recurrent pericarditis and acute myocarditis - inflammatory heart diseases with significant unmet medical needs - and as we prepare to initiate first-in-human clinical evaluation of CRD-38, our novel subcutaneously administered therapy for inflammatory heart disease, including heart failure. By securing this protection through late 2040, we are solidifying a strong foundation to support our global clinical and commercial strategy.”
“This patent allowance comes at an opportune time, adding extensive intellectual property protection in new areas of heart disease that have been identified for potential research expansion based on the recently reported topline ARCHER findings,” said Dr. Andrew Hamer, chief medical officer and head of research & development of Cardiol Therapeutics.
“We now look forward to presenting the comprehensive data from ARCHER - our randomized, double-blind, placebo-controlled phase II trial of CardiolRx in acute myocarditis - at the upcoming European Society of Cardiology Annual Meeting in Trieste on November 29, and to providing insights into potential new development opportunities in myocarditis, as well as the positive implications for our CRD-38 program in heart failure. We also look forward to providing an update on our pivotal phase III MAVERIC trial in recurrent pericarditis, as patient enrollment continues to accelerate across leading cardiovascular research centres in the US.”
The MAVERIC Programme is evaluating CardiolRx for the treatment of recurrent pericarditis, an inflammatory disease of the pericardium associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, which can lead to physical limitations, reduced quality of life, emergency department visits, and hospitalizations. The programme comprises the completed phase II MAvERIC-Pilot study (NCT05494788) and the ongoing pivotal Phase III MAVERIC trial (NCT06708299). The US FDA has granted Orphan Drug Designation to CardiolRx for the treatment of pericarditis, including recurrent pericarditis.
The ARCHER Programme is also studying CardiolRx, specifically in acute myocarditis—an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in individuals under 35 years of age. The program comprises the completed Phase II ARCHER study (NCT05180240), which evaluated the safety, tolerability, and efficacy of CardiolRx in this patient population.
The company is also developing CRD-38, a novel, subcutaneously administered drug formulation intended for the treatment of inflammatory heart disease, including heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding US$ 30 billion per year.
This allowance fortifies Cardiol’s global intellectual property portfolio, adding to granted and pending patent applications in Europe, Japan, Canada, Australia, and China.
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