Cardiol Therapeutics’ CardiolRx™ Demonstrates Marked Reduction in Pericarditis Pain
Clinical-stage life sciences company, Cardiol Therapeutics (Nasdaq: CRDL) has demonstrated a marked reduction in pericarditis pain in patients with symptomatic recurrent pericarditis treated with CardiolRx™. The company reported 8-week clinical data from its Phase 2 open-label MAvERIC-Pilot study evaluating CardiolRx™ in pericarditis, showing a substantial reduction in patient-reported pericarditis pain, as well as normalization of inflammation in 80% of patients.
CardiolRx™ was shown to be safe and generally well-tolerated, and 89% of the study’s 27 participants have continued into the extension phase of the trial.
David Elsley, Cardiol Therapeutics’ President and Chief Executive Officer, commented, “Based on the clinically meaningful impact of CardiolRx™ on the key symptom of this debilitating disease, we now anticipate that the totality of the MAvERIC-Pilot data will support advancing to a Phase III trial of CardiolRx™ designed to meet our objective of providing a more accessible and non-immunosuppressive therapy option for thousands of pericarditis patients.”
Recurrent pericarditis, inflammation of the membrane surrounding the heart, affects approximately 38,000 Americans. Symptoms include debilitating chest pain, shortness of breath, and fatigue that result in reduced quality of life and hospitalizations.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) 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. The Company’s lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, 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.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration (“US FDA”) to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), an inflammatory disease of the pericardium which 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; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis. Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually. For more information about Cardiol Therapeutics, please visit cardiolrx.com.
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