Cardiol Therapeutics Inc (TSX:CRDL, NASDAQ:CRDL) said it has enrolled the first patient in its Phase II study evaluating CardiolRx for the treatment of recurrent pericarditis.
The company-sponsored Phase II open-label pilot study is investigating the tolerance, safety, and efficacy of CardiolRx in patients with recurrent pericarditis – inflammation of the membrane that surrounds the heart, known as the pericardium.
The study will also evaluate improvement in objective measures of disease, and assess the feasibility of weaning concomitant background therapy including corticosteroids during an extension period, while taking CardiolRx.
READ: Cardiol Therapeutics kicks off a multi-center Phase II pilot study of CardiolRx for the treatment of recurrent pericarditis
The Phase II pilot study is expected to enroll 25 patients at clinical centers in the United States that specialize in pericarditis care, Cardiol said.
"We are excited to be the first clinical center to administer this investigational drug in a patient with recurrent pericarditis, a debilitating inflammatory heart disease associated with symptoms that adversely affect quality of life and physical activity," said Dr Paul C. Cremer, a cardiologist at the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic and study site principal investigator, in a statement.
According to Cardiol’s research collaborators at Virginia Commonwealth University, pre-clinical data supports the strong scientific basis for investigating CardiolRx clinically in recurrent pericarditis. Research demonstrates 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 which is responsible for the cycle of inflammation in recurrent pericarditis leading to the pericardial effusion and thickening characteristic of the disease.
"Along with other collaborating research centers throughout the US, we look forward to full enrollment of participants into this pilot study and to determining the potential of this therapy to treat pericarditis and to reduce the risk of its recurrence,” Dr Cremer added.
The primary efficacy endpoint in Phase II is the change over 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 circulating levels of C-reactive protein, a commonly used clinical marker of inflammation.
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