Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) Inc announced that the US Food and Drug Administration has authorized its Investigational New Drug Application to start its Phase II open-label pilot study.
The study will evaluate the tolerance and safety of Cardiol’s lead drug CardiolRx, a pharmaceutically-manufactured oral cannabidiol formulation for patients with recurrent pericarditis.
The condition refers to inflammation of the membrane that surrounds the heart, known as the pericardium. Recurrent pericarditis is the reappearance of symptoms after a symptom-free period of at least four to six weeks following an episode of acute pericarditis.
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Data indicates that recurrences appear in 15% to 30% of acute cases and usually within 18 months.
Recurrent pericarditis is an orphan disease in the US, which means CardiolRx is eligible for orphan drug status under the FDA's Orphan Drug Designation program.
Phase II is expected to enroll 25 patients at major clinical centers specializing in pericarditis in the US. The trial's primary efficacy endpoint is the change, from baseline to eight weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale. Secondary endpoints include the pain score after 26 weeks of treatment, and changes in C-reactive protein.
Dr Allan Klein will lead the study as chair.
“We look forward to evaluating whether this intervention could be a therapeutic option for those who are intolerant to current medical treatment or who require long-term administration of corticosteroids to control their disease,” Klein said in a statement.
"We are pleased that Dr. Klein will provide his expertise and leadership to Cardiol's study, and his contributions thus far with respect to protocol design and facilitating clinical trial site recruitment have been invaluable," Dr Andrew Hamer, Cardiol's chief medical officer told investors.
"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. With IND authorization now in place, we look forward to ramping up initiation of this important study.”
Hamer added that Cardiol anticipates benefiting from the clinical trial infrastructure already established for its multi-national acute myocarditis study, which is expected to commence patient enrollment “imminently.”
Oakville, Ontario-based Cardiol is a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-fibrotic and anti-inflammatory therapy for the treatment of cardiovascular disease.
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