Cardiol Therapeutics Finishes Enrollment for Phase II Study on Recurrent Pericarditis Treatment

Cardiol Therapeutics, a life sciences firm dedicated to advancing treatments for heart disease, has successfully completed patient recruitment for its Phase II clinical trial, known as MAvERIC-Pilot. This study is assessing the safety, tolerability, and effectiveness of their drug candidate, CardiolRx™, in treating patients suffering from recurrent pericarditis, a condition characterized by the inflammation of the pericardium, the protective sac around the heart.

The MAvERIC-Pilot study, which has enrolled 25 participants in the United States, aims to measure improvements in the patients' condition using an 11-point numeric rating scale to evaluate pain levels. The primary goal is to observe changes in pain from the beginning of the study to 8 weeks post-treatment. Secondary objectives include assessing pain levels after 26 weeks and monitoring changes in C-reactive protein levels, a standard marker for inflammation, as well as tracking the recurrence of pericarditis.

Recurrent pericarditis can lead to severe chest pain, difficulty breathing, and fatigue, severely impacting the patient's quality of life and physical capabilities. In the United States, it is estimated that around 38,000 patients experience at least one episode of recurrence annually. The current FDA-approved treatment, introduced in 2021, is expensive and typically reserved for third-line interventions.

CardiolRx™, the company's lead drug candidate, is a cannabidiol-based oral solution that has been recognized for its potential to inhibit the inflammasome pathway, a cellular process linked to inflammation and fibrosis associated with various heart conditions. The US FDA has granted Orphan Drug Designation to CardiolRx™ for treating pericarditis, highlighting its potential significance for patients with this rare and debilitating disease.

Cardiol Therapeutics is also developing a novel subcutaneous drug formulation of cannabidiol for heart failure treatment, a condition that is a major cause of death and hospitalization globally, with substantial healthcare costs in the United States alone exceeding $30 billion each year.

The company anticipates releasing the high-level clinical trial data from the MAvERIC-Pilot study in the second quarter of 2024, which will be instrumental in planning a critical Phase III clinical trial. This data is expected to support the potential regulatory approval of CardiolRx™, offering a new treatment option for patients with recurrent pericarditis.