“Advanced ARCHER Trial Launched: Cardiol Rx Treats Acute Myocarditis

Cardiol Therapeutics Inc. has recently announced the initiation and eligibility of all collaborating clinical research centers for enrolling patients in Archer, a Phase II trial for the treatment of acute myocarditis using CardiolRx. This trial is a double blind, randomized, placebo-controlled study at 35 clinical sites across the United States and Europe. CardiolRx is an intranasal formulation of the active pharmaceutical ingredient, methylene blue. It has been developed to be one of the first non-invasive, non-steroidal therapies for the treatment of acute myocarditis. Acute myocarditis is an inflammation of the heart muscle and is primarily caused by a virus. Current treatment options for acute myocarditis may not provide enough relief and can lead to recurrence of the condition. Furthermore, Cardiol Therapeutics touts CardiolRx as a safe and effective treatment option for acute myocarditis with minimal side effects. The company has already seen an 81.3% decrease in the heart-related biomarkers of inflammation in clinical study with the intranasal formulation of methylene blue. CardiolRx also has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential therapeutic for acute myocarditis. Cardiol Therapeutics is now enrolling patients for the Phase II clinical trial, Archer. Across 35 clinical research centers, the company is recruiting up to 248 adult patients with a confirmed diagnosis of acute myocarditis. This is an important step for Cardiol Therapeutics as the trial results are expected to form the basis of a future regulatory filing with the FDA. Cardiol Therapeutics has previously conducted clinical trials in humans using the intranasal formulation of methylene blue. The study results showed that the therapy had a positive impact on reducing heart-related inflammation biomarkers. With the initiation and eligibility of all collaborating clinical research centers for enrolling patients in Archer, the company hopes to continue its successful clinical research path with CardiolRx.