Cardiol Therapeutics announces database lock for myocarditis trial

TORONTO - Cardiol Therapeutics Inc. (NASDAQ:CRDL) (TSX:CRDL), a clinical-stage biotechnology company with a current market capitalization of $100.83 million, announced Tuesday the database lock for its Phase II ARCHER trial investigating CardiolRx in patients with acute myocarditis, with topline results expected within two weeks. InvestingPro data shows the company maintains a healthy balance sheet with more cash than debt and a strong current ratio of 3.26x.

The multi-national, randomized, double-blind, placebo-controlled trial enrolled over 100 patients from research centers in the United States, France, Brazil, and Israel. The study is designed to assess the impact of CardiolRx on cardiac magnetic resonance imaging parameters that measure heart dysfunction and fibrosis. While InvestingPro analysis indicates the company is currently burning through cash, it maintains sufficient liquid assets to exceed short-term obligations.

ARCHER’s primary outcome measures evaluate global longitudinal strain and extra-cellular volume following 12 weeks of therapy, both recognized as prognostic markers in acute myocarditis patients.

"Database lock marks another important milestone in the ARCHER program, enabling statistical analysis, unblinding, and the reporting of topline results," said David Elsley, President and CEO of Cardiol Therapeutics, in a press release statement.

Acute myocarditis is an inflammatory condition of the heart muscle that can lead to heart failure or sudden cardiac death. It is characterized by symptoms including chest pain, shortness of breath, fatigue, and irregular heartbeat. The condition is a leading cause of sudden cardiac death in people under 35 years of age.

Currently, there are no FDA-approved drug therapies for acute myocarditis. Patients hospitalized with the condition experience an average seven-day length of stay with hospital charges estimated at $110,000 in the United States.

Cardiol Therapeutics is also conducting a Phase III trial called MAVERIC to evaluate CardiolRx in recurrent pericarditis, and is developing CRD-38, a subcutaneously administered drug formulation for heart failure.

In other recent news, Cardiol Therapeutics has been the focus of significant developments. H.C. Wainwright analysts have initiated coverage on Cardiol Therapeutics with a Buy rating, setting a price target of $9.00 per share. This move highlights a positive outlook from the firm regarding the company’s future performance. Additionally, Cardiol Therapeutics has announced the nomination of Dr. Timothy J. Garnett, a former Chief Medical Officer of Eli Lilly, for election to its Board of Directors. Dr. Garnett brings over 30 years of experience in the pharmaceutical industry, including expertise in clinical development and regulatory strategy. His nomination is scheduled for a vote at the company’s Annual General Meeting on May 28, 2025. These developments reflect Cardiol Therapeutics’ strategic efforts to enhance its leadership and market position.

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