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Pericarditis is the inflammation of the pericardium, which is the membrane or sac that surrounds the heart. Symptoms range from chest pain to shortness of breath and fatigue. Recurrent pericarditis is a disease with major short and long-term challenges. It occurs when pericarditis is developed for a second time after having no symptoms for at least four weeks.
In order to treat the condition, Cardiol Therapeutics has initiated a Phase II open-label study that will investigate the tolerance, safety and efficacy of CardiolRx™ in patients with recurrent pericarditis.
Cardiol Therapeutics initiates Phase II study
In a press release, the company said the study will also aim to evaluate improvement in objective measures of the condition while assessing the feasibility of weaning concomitant background therapy, including corticosteroids.
The Phase II study will enroll at least 25 patients at clinical centers across the United States specializing in pericarditis care.
“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,” commented David Elsley, CEO of Cardiol Therapeutics’, said in a press release. “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 supporting the use of CardiolRx™ as a novel therapy for this debilitating and frequently undertreated disorder. We are pleased to have the study underway, and we share the enthusiasm demonstrated by the study investigators in evaluating the clinical potential of CardiolRx™ in pericarditis.”
The company said it had previously presented preclinical data that supports the scientific basis for investigating CardiolRx™ in recurrent pericarditis at the American Heart Association Scientific Sessions 2022. Cardiol’s research collaborators from Virginia Commonwealth University presented the results, which demonstrated the effects of CardiolRx™ in a model of pericarditis.
Cardiol Therapeutics in the news
Cardiol Therapeutics has been busy this year as it continues to advance CardiolRx™. In August, the company enrolled its first patient in its ARCHER Phase II clinical trial for acute myocarditis.
“We have long suspected that it is the response to injury that needs to be addressed to improve outcomes in myocarditis. Given its impact limiting these inflammatory mechanisms, we believe cannabidiol has the potential to truly benefit patients with this condition,” Dennis McNamara, MD, MS professor of medicine at the University of Pittsburgh Medical Center and chair of the study, said in a release. “I am pleased this important milestone has been achieved, and the ARCHER study, designed to investigate CardiolRx’s therapeutic potential in myocarditis, is formally underway.”
ARCHER has received regulatory clearance in multiple jurisdictions, including Investigational New Drug Application (IND) authorization from the U.S. Food and Drug Administration, and is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel.
The investment corner
For investors new to the life scenes market, Cardiol Therapeutics presents itself as a sound investment opportunity. The company has an advanced research and development pipeline and has a number of clinical trials in place that target areas with unmet medical needs.
With 2022 coming to a close, Cardiol Therapeutics will undoubtedly have plenty to look forward to in 2023.
For more information, please visit https://www.cardiolrx.com/
FULL DISCLOSURE: This is a paid article by The Market Herald.