Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) Inc CEO David Elsley told investors in a year-end 2022 update on operations that the life sciences company has made “important progress” with the development of CardiolRx, its lead drug candidate for the treatment of inflammation and fibrosis in heart disease.
The Oakville, Ontario-based company issued the update following the filing of its audited financial statements for the year ended December 31, 2022.
“We initiated the ARCHER trial, a multi-national clinical study in acute myocarditis, that is one of the largest company-sponsored clinical trials to be undertaken in this underserved condition in over 30 years,” Elsley said in the update.
Last year, Cardiol initiated patient enrollment in ARCHER Trial, a Phase II clinical trial evaluating the safety and efficacy of CardiolRx in patients with acute myocarditis, which is a cause of acute and sudden heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years old.
“Our research collaborators presented compelling evidence at The American Heart Association demonstrating the ability of CardiolRx to confer cardioprotective effects in a model of recurrent pericarditis. This presentation was followed by the initiation of our US Phase II open-label pilot study in patients with recurrent pericarditis at the renowned Cleveland Clinic and Mayo Clinic sites," said Elsley.
"These clinical advancements have been complemented with important basic science initiatives that have furthered our understanding of CardiolRx's mode of action in inflammatory heart disease.”
Elsley noted that Cardiol is in a strong financial position, with cash to achieve its corporate milestones and “fund operations into 2026.”
Cardiol highlighted the following clinical developments:
- In May, Cardiol received Investigational New Drug (IND) application authorization from the US Food and Drug Administration (FDA) to conduct a multi-center Phase II open-label pilot study of CardiolRx for recurrent pericarditis, extending orphan drug eligibility for CardiolRx to a second heart disease, alongside acute myocarditis.
- In August, Cardiol revealed that the first patient had been enrolled in ARCHER, the Phase II double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. ARCHER is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel.
- In December, Cardiol started a Phase II pilot study, to investigate the safety and efficacy of CardiolRx in patients with recurrent pericarditis. In addition to standard safety assessments, the study is designed to evaluate improvement in objective measures of disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx. The Cleveland Clinic and the Mayo Clinic study sites were initiated and are eligible to recruit participants. The first patient was enrolled in January 2023.
Investors can read highlights about the company’s pre-clinical developments and corporate updates here.
Outlook
During the next 12-24 months, Cardiol expects the following key corporate milestones to be achieved:
- Completion of patient enrollment in the company-sponsored Phase II pilot study (NCT05494788) investigating the tolerance, safety, and efficacy of CardiolRx in patients with recurrent pericarditis. During an extension period, the study will also weigh the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx.
- Completion of patient enrollment into ARCHER, the Phase II trial (NCT05180240) designed to study the safety and tolerability of CardiolRx, as well as its impact on myocardial recovery, in patients with acute myocarditis. Although viral causes of myocarditis are common, myocarditis can result from infections and certain drugs, including chemo-therapeutic agents used to treat several cancers. Myocarditis can also manifest as post-acute sequelae of SARS-CoV-2 infection. It has also been reported as a rare complication associated with certain vaccines for COVID-19. Cardiol says there’s an opportunity to develop CardiolRx as an orphan drug for the treatment of acute myocarditis, for which there is currently no accepted standard of care.
- Advance Cardiol’s novel subcutaneously administered drug formulation of cannabidiol as a potential anti-fibrotic and anti-inflammatory therapy for use in heart failure.
Heart failure is a leading cause of death in the developed world, with associated annual healthcare costs in the US exceeding $30 billion annually, according to the company.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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