Cardiol Therapeutics Inc. (CRDL) is approaching a key clinical milestone related to its lead asset, CardiolRx.
CardiolRx (cannabidiol) oral solution is in clinical development for use in the treatment of heart disease.
A phase II study of CardiolRx in patients with acute myocarditis, dubbed ARCHER, is underway.
Acute myocarditis refers to an inflammatory condition of the heart muscle (myocardium), often resulting from viral infection. Its symptoms include chest pain, fatigue, shortness of breath, palpitations, edema, or swelling in the legs, ankles, and feet, and flu-like symptoms. There are no FDA-approved treatments for myocarditis, which is a major cause of sudden cardiac death in people under 35 and can lead to severe heart failure.
The ARCHER trial has enrolled over 100 patients at 34 clinical sites in the United States, Canada, France, Brazil, and Israel. Its two primary outcome measures include myocardial magnetic resonance imaging parameters: global longitudinal strain, which assesses heart dysfunction, and extracellular volume, which evaluates edema and fibrosis.
Today, Cardiol announced that it has completed the database lock for the ARCHER study.
Database lock is the formal, irreversible process of closing the clinical database for statistical analysis after all trial data has been reviewed, cleaned, and finalized. (Source: Clinical Studies.in)
The topline results from the ARCHER study are expected within the next two weeks.
CRDL closed yesterday’s trading at $1.22, up 2.52%.
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