The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) from Cardiol Therapeutics Inc. (NASDAQ: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
