Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has announced significant topline results from its Phase II MAvERIC-Pilot study, which investigated the efficacy of CardiolRx™ in treating symptomatic recurrent pericarditis. This announcement adds to a year of remarkable achievements for the Canadian biotechnology company, which has seen over a 180% increase in its stock price and the advancement of two simultaneous Phase II clinical trials. Additionally, the company has received Orphan Drug Designation from the US FDA for CardiolRx™.
Recurrent pericarditis is a debilitating condition characterized by persistent inflammation of the pericardium, leading to intense chest pain, shortness of breath, and fatigue. The condition affects approximately 38,000 patients annually in the U.S., with many experiencing multiple recurrences over several years. The current FDA-approved therapy for recurrent pericarditis, introduced in 2021, is costly and primarily used as a third-line intervention, often posing significant risks typical of immunosuppressants.
The MAvERIC-Pilot study included 27 adult patients with symptomatic recurrent pericarditis across eight clinical sites in the United States, including the Mayo Clinic and Cleveland Clinic. Patients reported an average baseline pain score of 5.8 on an 11-point numeric rating scale (NRS). The primary endpoint was the change in patient-reported pain at eight weeks, with secondary endpoints including pain scores after 26 weeks and changes in C-reactive protein (CRP) levels, a marker of inflammation.
Key findings from the study revealed a significant reduction in pain, with the mean pain score dropping from 5.8 at baseline to 2.1 after eight weeks of treatment. This 64% reduction marks a decrease of 3.7 points on the NRS. Additionally, 80% of patients with elevated baseline CRP levels (≥1 mg/dL) achieved normalization of CRP levels (≤0.5 mg/dL) by the end of the eight-week treatment period. The average CRP levels were reduced from 5.7 mg/dL to 0.3 mg/dL, indicating a substantial reduction in inflammation.
Furthermore, 89% of patients continued into the extension phase of the study, suggesting that CardiolRx™ is well-tolerated. The study confirmed that CardiolRx™ was found to be safe and well-tolerated, with no significant adverse effects reported.
David Elsley, President & CEO of Cardiol Therapeutics, expressed optimism about the potential of CardiolRx™ as a non-immunosuppressive therapeutic option for pericarditis. He highlighted the drug's comparable efficacy to existing biologic therapies used in third-line treatment of recurrent pericarditis, stating, “We are delighted to share the exceptional primary endpoint data from the MAvERIC-Pilot study, which demonstrated that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain and inflammation. These reductions are comparable in magnitude to biologic therapy commonly used in third-line treatment of recurrent pericarditis.”
The promising results from the MAvERIC-Pilot study set the stage for a forthcoming Phase III trial, aiming to further validate the efficacy and safety of CardiolRx™. This advancement could potentially provide an accessible and non-immunosuppressive treatment option for thousands of pericarditis patients, addressing a critical need for effective and safer therapies in the medical community.
With frequent hospitalizations and emergency room visits driving up healthcare costs for recurrent pericarditis patients, a more effective and well-tolerated treatment could significantly reduce the economic burden on the healthcare system. Hospital stays for this condition often range between $20,000 and $30,000, with lengths of stay averaging 6-8 days.
As Cardiol Therapeutics progresses towards commercialization, the company is poised to make a substantial impact on patient care and the broader biotech industry by providing a novel therapeutic option for recurrent pericarditis.
