CardiolRx Falls Short in Phase II Myocarditis Trial

Cardiol Therapeutics’ cannabidiol-based oral therapy, CardiolRx, failed to meet co-primary endpoints in the Phase II ARCHER study for myocarditis. While showing a numerical reduction in left ventricular extracellular volume (LV-ECV) after 12 weeks, results narrowly missed statistical significance (p=0.0538). The treatment also did not significantly improve global longitudinal strain (GLS) scores in patients with preserved LV function. However, CardiolRx achieved notable secondary benefits, including a significant reduction in left ventricular mass.

Following the announcement, Cardiol Therapeutics’ Nasdaq shares fell 20%, from $1.35 to $1.07. The company has not confirmed plans for a Phase III myocarditis trial but will integrate findings into its broader development strategy, alongside the ongoing Phase III MAVERIC trial in recurrent pericarditis. While CBD therapies remain under regulatory and accessibility constraints globally, Cardiol is advancing its subcutaneous CBD candidate, CRD-38, which analysts suggest could hold promise in heart failure due to its unique mechanism of action.

11-08-2025