Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) told investors it has exceeded 50% patient enrollment for its Phase II ARCHER trial.
The multi-center, international, double-blind, randomized, placebo-controlled trial is investigating the safety, tolerability, and impact of CardiolRx on myocardial recovery in patients presenting with acute myocarditis. The trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in North America, France, Brazil, and Israel.
"Achieving this milestone reflects the commitment and interest demonstrated by our clinical collaborators and participating patients, and we thank them for their contribution to the progress being made in this important clinical trial," Cardiol Therapeutics' President and CEO David Elsley commented in a statement.
"Acute myocarditis is an inflammatory heart disease that impairs heart function, is associated with symptoms that can seem like a heart attack, 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."
The company said 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 (extra-cellular 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.
"Results from the ARCHER trial will assist in further understanding the therapeutic potential of CardiolRx and will complement the important clinical data from our ongoing MAvERIC-Pilot Phase II study in patients presenting with recurrent pericarditis," Elsley added.
The company's TSX-listed shares were up 2.2% at C$1.39 in early afternoon trade in Toronto. In New York, its Nasdaq-listed stock was 2% higher at US1.02.
Oakville, Ontario-based Cardiol Therapeutics specializes in developing anti-inflammatory and anti-fibrotic therapies for heart disease, with its lead drug candidate, CardiolRx oral solution, currently in clinical development. The pharmaceutical-grade cannabidiol is designed to inhibit the inflammasome pathway, a key process implicated in the inflammation and fibrosis linked to conditions like myocarditis, pericarditis, and heart failure.
~Updated with share price movement~