Cardiol Therapeutics Achieves Target Patient Enrollment in its Phase II

Overview

Cardiol Therapeutics (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 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.

Cardiol is also developing a novel subcutaneously administered drug formulation of cannabidiol 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.

Company Highlights

• Lead Asset in Clinical Development: CardiolRx™, oral drug candidate, in Phase II trials for recurrent pericarditis and acute myocarditis.
• Scientific Rationale: Compelling evidence demonstrating the anti-inflammatory and antifibrotic properties of CardiolRx in myopericardial diseases.
• Innovative Research: Advancing the development of CRD-38, a novel proprietary subcutaneously administered pharmaceutical intended for use in heart failure.
• CRD-38 Positive Study Results: Positive study results demonstrating CRD-38 subcutaneous formulation slowed increases in body weight and heart weight, and prevented increases in key cardiac inflammatory and remodeling markers in a model of heart failure with preserved ejection fraction.
• Broad Exclusivity Protection: Comprehensive intellectual property portfolio. Eligible to pursue FDA orphan drug and EMA orphan medicine designations for CardiolRx.
• Leadership: Experienced management team, board of directors, and scientific advisory board, with extensive expertise in developing therapeutics for inflammatory heart disease.
• Strong Financial…