Mr. Andrew Hamer reports

CARDIOL THERAPEUTICS ACHIEVES TARGET PATIENT ENROLLMENT IN ITS PHASE II ARCHER TRIAL INVESTIGATING CARDIOLRX FOR ACUTE MYOCARDITIS

Cardiol Therapeutics Inc. has achieved the target patient enrolment of 100 patients in Archer, its phase II randomized, double-blind, placebo-controlled trial evaluating the impact of CardiolRx on myocardial recovery in patients with acute myocarditis.

"We are pleased to have achieved our target patient enrolment in the Archer trial, which reflects the commitment and dedication of our clinical collaborators and participating patients. Reaching this milestone is integral to enhancing our understanding of the therapeutic impact of CardiolRx in acute myocarditis, a debilitating and potentially life-threatening inflammatory heart disease that significantly impairs cardiac function and patient quality of life," said Andrew Hamer, Cardiol Therapeutics' chief medical officer and head of research and development. "With top-line results expected early next year, the data from the Archer trial is anticipated to offer key insights concerning the effects of CardiolRx on myocardial recovery. Furthermore, we anticipate these findings will complement the clinical data from our Maveric phase II study in recurrent pericarditis, the full results of which will be presented in November at the American Heart Association Scientific Sessions 2024."

Archer study design

The design and rationale for Archer were published June 27, 2024, in the journal ESC Heart Failure. Archer is a phase II multinational, randomized, double-blind, placebo-controlled trial investigating the safety, tolerability and impact of CardiolRx on myocardial recovery in patients presenting with acute myocarditis. The study has an enrolment target of 100 patients to be recruited from pre-eminent cardiovascular research centres in the United States, Canada, France, Brazil and Israel. The primary outcome measures of the trial, which will be evaluated following 12 weeks of double-blind therapy, consist of two cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extracellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. Additional efficacy outcome measurements include survival, freedom from major cardiovascular events, resolution of clinical symptoms, and change in biomarkers associated with cardiac function and inflammation.

Acute myocarditis

Acute myocarditis is an inflammatory condition of the heart muscle (myocardium) characterized by chest pain, shortness of breath at rest or during activity, fatigue, rapid or irregular heartbeat (arrhythmias), and lightheadedness or the feeling one might faint. The disease is an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. Viral infection is the most common cause of myocarditis; however, it can also result from bacterial infection and commonly used drugs and mRNA vaccines as well as therapies used to treat several common cancers, including chemotherapeutic agents and immune checkpoint inhibitors. There are no FDA-approved (U.S. Food and Drug Administration) therapies for acute myocarditis. Patients hospitalized with the condition experience an average seven-day length of stay and a 4-per-cent to 6-per-cent risk of in-hospital mortality, with average hospital charge per stay estimated at $110,000 in the United States.

Cardiol believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States and the European Union. Orphan drug designation programs were established to provide life sciences companies with incentives to develop new therapies for rare diseases. These incentives include periods of prolonged marketing exclusivity and exemptions from certain fees. Products with orphan drug designation also frequently qualify for accelerated regulatory review.

About Cardiol Therapeutics Inc.

Cardiol Therapeutics 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 U.S. FDA to conduct clinical studies to evaluate the efficacy and safety of CardiolRx in two diseases affecting the heart: (i) a phase II multicentre, 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 multinational, 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 U.S. 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 health care costs in the United States exceeding $30-billion annually.

We seek Safe Harbor.