FDA Clears Cardiol Therapeutics' IND for CardiolRx in Recurrent Pericarditis

The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) from Cardiol Therapeutics Inc. CRDL to start a Phase 2 open-label pilot study designed to evaluate the tolerance and safety of CardiolRx, in patients with recurrent pericarditis.

The Phase 2 clinical trial is expected to enroll 25 patients at major clinical centers in the United States.

The primary endpoint of this study is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS).

Dr. Andrew Hamer, Chief Medical Officer, commented : "We believe there is a significant opportunity to develop a new oral, well tolerated therapy for treating recurrent pericarditis to prevent multiple recurrences, for colchicine refractory, intolerant, and contraindicated patients, as well as steroid-dependent patients. We also anticipate benefiting from the clinical trial infrastructure already established for our multi-national acute myocarditis study, which is expected to commence patient enrollment imminently.”

Shares of Cardiol Therapeutics’ are trading high 10 percent at $1.24