Cardiol Therapeutics Inc. (NASDAQ: CRDL, TSX: CRDL) has been added to the PRISM Emerging Biotech Index, a list that highlights companies leading innovation and creating market impact within the biotech sector. Cardiol's focus on anti-inflammatory and anti-fibrotic therapies for heart disease, including its lead candidate CardiolRx™, positions it as a pioneer in addressing major unmet needs in cardiac care.
CardiolRx™ for Pericarditis
The U.S. FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, including recurrent pericarditis. Recurrent pericarditis affects approximately 38,000 patients in the United States annually who have experienced at least one recurrence. The global pericarditis market was valued at $2.44 billion in 2023 and is projected to grow at a CAGR of 5.24% during the forecast period of 2024-2032, reaching $3.87 billion by 2032.
Cardiol's MAVERIC Program in recurrent pericarditis comprises the Phase II MAvERIC-Pilot study (NCT05494788), the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial. The MAVERIC-2 trial will evaluate the impact of CardiolRx™ in recurrent pericarditis patients following the cessation of interleukin-1 blocker therapy. MAVERIC-2 is expected to initiate in Q4 2024 at major pericardial disease centers across the United States and Europe, with results anticipated ahead of the company’s planned pivotal Phase III MAVERIC-3 trial.
Recurrent pericarditis, an inflammatory disease of the pericardium, is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations.
CRD-38 for Heart Failure
In addition to CardiolRx™, Cardiol is advancing CRD-38, a proprietary subcutaneously administered therapy for heart failure. Heart failure is a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
Cardiol’s broad IP portfolio and regulatory pathway focus, including FDA and European Medicines Agency orphan designations, bolster its strong market positioning. The company is debt-free and well-capitalized to achieve corporate milestones into 2026.
Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. CardiolRx (cannabidiol) oral solution, the Company’s lead small molecule drug candidate, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis and heart failure.