Cardiol Therapeutics Reports Positive Phase II MAvERIC-Pilot Study Results for CardiolRx™ in Recurrent Pericarditis

Cardiol Therapeutics Inc., a clinical-stage life sciences company based in Toronto, Ontario, has reported promising results from its Phase II open-label MAvERIC-Pilot study. The study evaluates the impact of CardiolRx™, an anti-inflammatory and anti-fibrotic therapy, on patients suffering from symptomatic recurrent pericarditis. The eight-week clinical data revealed significant reductions in patient-reported pericarditis pain and inflammation.

David Elsley, President and CEO of Cardiol Therapeutics, emphasized the substantial reductions in pain and inflammation achieved with CardiolRx™. These results align closely with those observed in immunosuppressive biologic therapies typically used as third-line treatments for recurrent pericarditis. Given these encouraging findings, the company is optimistic about progressing to a Phase III trial. This next phase aims to provide a more accessible, non-immunosuppressive treatment option for numerous pericarditis patients.

The MAvERIC-Pilot study involved 27 patients diagnosed with symptomatic recurrent pericarditis, each reporting a high disease burden. The mean baseline pericarditis pain score was 5.8 out of 10. The study's topline results are noteworthy. The primary endpoint showed a mean reduction of 3.7 points in pericarditis pain scores, from a baseline of 5.8 to 2.1 at the end of the eight-week treatment period. Additionally, 80% of patients with elevated C-reactive protein (CRP) levels at baseline experienced normalization of CRP levels. The mean CRP dropped from 5.7 mg/dL at baseline to 0.3 mg/dL.

An impressive 89% of patients have moved from the treatment phase into the extension phase of the study, which involves an additional 18 weeks of CardiolRx™ treatment. CardiolRx™ has been well-tolerated and safe throughout the study, further supporting its potential for widespread use.

The MAvERIC-Pilot study design includes 27 adult participants, aged 18 and above, with symptomatic recurrent pericarditis. The study is conducted across eight clinical sites in the United States under the guidance of Dr. Allan L. Klein, Director of the Center of Pericardial Diseases at the Cleveland Clinic. The study comprises an eight-week treatment period followed by an 18-week extension period. Patients with an NRS pain score of 4 or higher and either elevated CRP or evidence of pericardial inflammation were enrolled. CardiolRx™ was administered alongside stable doses of baseline therapy for recurrent pericarditis, which includes non-steroidal anti-inflammatory drugs, colchicine, or corticosteroids. Patients were gradually weaned off these baseline therapies during the extension period to assess recurrence.

Recurrent pericarditis is characterized by inflammation of the pericardium, often following an initial episode triggered by a viral infection. Symptoms include severe chest pain, shortness of breath, and fatigue, which significantly impact quality of life and can lead to emergency department visits and hospitalizations. The condition can also result in life-threatening complications such as pericardial fluid accumulation and scarring, leading to heart constriction. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is expensive and primarily used as a third-line treatment. Annually, around 38,000 patients in the United States experience at least one recurrence of pericarditis.

Cardiol Therapeutics is committed to developing anti-inflammatory and anti-fibrotic therapies for heart disease. The company's lead drug candidate, CardiolRx™ (cannabidiol), is in clinical development for treating heart disease. The company has received authorization from the US FDA to conduct clinical studies on CardiolRx™ for heart conditions, including recurrent pericarditis and acute myocarditis. Additionally, Cardiol is developing CRD-38, a new drug formulation intended for heart failure treatment.