Cardiol Therapeutics Surpasses 50% Enrollment in Phase II ARCHER Acute Myocarditis Trial

Cardiol Therapeutics Inc., a clinical-stage life sciences company, has surpassed the halfway mark for patient enrollment in its ARCHER Phase II clinical trial. This multi-center, international study is designed to assess the safety, tolerability, and effectiveness of CardiolRx™ in patients with acute myocarditis. David Elsley, the company's President and CEO, acknowledged the milestone as a testament to the commitment of clinical collaborators and participants.

Acute myocarditis is an inflammatory heart condition that can mimic a heart attack and is a significant cause of heart failure and sudden cardiac death in individuals under the age of 35. The ARCHER trial will yield data crucial for understanding the therapeutic potential of CardiolRx™, complementing data from the ongoing MAvERIC-Pilot Phase II study focusing on recurrent pericarditis.

The trial has been coordinated with input from a steering committee composed of leading experts in heart failure and myocarditis. It aims to enroll 100 patients across North America, France, Brazil, and Israel. The primary endpoints will be measured via cardiac magnetic resonance imaging (MRI) after 12 weeks of treatment. These will include assessments of left ventricular function and myocardial edema/fibrosis, both of which predict long-term prognosis in acute myocarditis cases. Additional outcomes include survival rates, freedom from major cardiovascular events, resolution of symptoms, and changes in biomarkers related to cardiac function and inflammation.

Myocarditis presents with symptoms like chest pain, shortness of breath, fatigue, and arrhythmias. Despite often starting with mild flu-like symptoms, the condition can escalate, necessitating hospitalization and posing a significant risk of mortality. The disease is mainly caused by viral infections but can also result from bacterial infections, medications, and treatments for certain cancers.

Currently, there are no FDA-approved treatments for acute myocarditis. Hospital stays average seven days with a 4-6% mortality rate, and the cost per stay in the U.S. averages $110,000. Cardiol is pursuing the development of a new therapy for acute myocarditis, which could potentially earn orphan drug designation in both the U.S. and the European Union. This designation provides benefits like marketing exclusivity and regulatory fee waivers to encourage the development of treatments for rare diseases.

Cardiol Therapeutics Inc. focuses on developing anti-inflammatory and anti-fibrotic treatments for heart disease. Its lead product, CardiolRx™ (cannabidiol) oral solution, is under clinical investigation for treating heart conditions. Cannabidiol is known to inhibit the inflammasome pathway, which plays a critical role in inflammation and fibrosis seen in myocarditis, pericarditis, and heart failure.

Cardiol has received authorization from the U.S. FDA to conduct clinical trials to evaluate CardiolRx™ for two heart conditions: recurrent pericarditis and acute myocarditis. The company is also developing a subcutaneous form of cannabidiol for heart failure treatment, a major cause of death and hospitalization with significant healthcare costs in the U.S.