Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) Inc revealed that it had initiated a Phase II open-label pilot study to investigate the safety and effectiveness of its lead product candidate CardiolRx in patients with recurrent pericarditis, which refers to inflammation of the pericardium, the membrane or sac that surrounds the heart to hold it in place and help it to work.
In addition to standard safety assessments, the Oakville, Ontario-based clinical-stage life sciences company said the study is designed to evaluate improvement in objective measures of disease, and during an extension period, assess the feasibility of a weaning concomitant background therapy including corticosteroids, while taking CardiolRx.
"The initiation of this important study at the Cleveland Clinic and the Mayo Clinic marks an important milestone in our efforts to improve treatment options for patients with recurrent pericarditis," Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) CEO David Elsley said in a statement.
READ: Cardiol Therapeutics unveils new study data highlighting protective effects of CardiolRx in acute pericarditis
"Recurrent pericarditis is an inflammatory heart disease with symptoms that include sharp stabbing chest pain, shortness of breath, and fatigue, thereby limiting an individual's physical activity and quality of life. The data generated from patients who enroll in the study at our collaborating research centers will provide further information in support of the use of CardiolRx as a novel therapy for this debilitating and frequently undertreated disorder,” he added.
Phase II pilot study
Cardiol’s Phase II pilot study (NCT05494788), which is underway is expected to enroll 25 patients at clinical centers in the US that specialize in pericarditis care. The protocol has been designed in collaboration with thought leaders in pericardial disease. The study Chairman is Allan L. Klein, Director of the Center for the Diagnosis and Treatment of Pericardial Diseases and Professor of Medicine at the Cleveland Clinic.
The primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS), according to the company. The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the pain score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation.
Pre-clinical data in recurrent pericarditis was recently presented at the American Heart Association Scientific Sessions 2022. Cardiol's research collaborators from Virginia Commonwealth University presented results demonstrating the protective effects of CardiolRx in a model of pericarditis, which included a significant reduction in imaging signs of pericardial effusion and thickening, and significant suppression of key pro-inflammatory markers interleukin-1β (IL-1β) and interleukin-6 (IL-6). The release of these cytokines IL-1β and IL-6 is responsible for the cycle of inflammation in recurrent pericarditis, according to the company.
CardiolRx is a pharmaceutically manufactured oral cannabidiol formulation that is being clinically developed for use in heart diseases.
Cardiol Therapeutics is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart diseases.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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