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In a phenomenal year marked by over +180% gains in its stock price, Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) added another feather to its cap last week with the announcement of its Phase II MAvERIC-Pilot study topline results.
The Canadian biotechnology company has captured investors’ attention this year with significant milestones achieved, including the advancement of two simultaneous Phase II clinical trials, granting of Orphan Drug Designation by the US FDA for its flagship drug CardiolRx™, and most recently, the announcement of positive topline results from their MAvERIC-Pilot study. These achievements further solidify Cardiol Therapeutics' position as a formidable player in the biotech landscape, offering renewed hope to patients suffering from debilitating rare heart conditions.
Last week, Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) reported 8-week clinical data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis. The study enrolled 27 adult patients with symptomatic recurrent pericarditis at eight clinical sites across the United States, including the prominent Mayo Clinic, Cleveland Clinic, and Massachusetts General Hospital. Each patient had a high burden of disease, as reflected by both a patient-reported pain score averaging 5.8 out of 10 at baseline and the number of previous episodes of pericarditis (9 patients, or 33%, had 2 previous episodes, 9 patients, or 33%, had 3 such episodes, 4 patients, or 15%, had 4 episodes, and 5 patients, or 19%, had more than 4 episodes).
The primary endpoint of the Phase II study is the change in patient-reported pericarditis pain at eight weeks, as measured by an 11-point numeric rating scale (NRS) that has been validated and applied in several clinical trials. NRS is commonly used to assess pain severity by using a scale from 0 to 10, where zero is "no pain" and 10 is "the worst pain imaginable.". Secondary endpoints include the NRS score after 26 weeks of treatment and changes in circulating levels of C-reactive protein (CRP). CRP is a commonly used marker of inflammation in patients with cardiovascular disease.
MAvERIC-Pilot topline data revealed several key findings:
Efficacy in Pain Reduction: Patients treated with CardiolRx™ experienced a significant reduction in the subjectively perceived pain of the pericarditis. The mean pain score dropped from 5.8 at baseline to 2.1 (64%) after eight-weeks of treatment, marking a decrease of 3.7 points on the 11-point NRS.
Reduction in Inflammation: Among patients with elevated baseline CRP (≥1 mg/dL), 80% achieved normalization of CRP levels (≤0.5 mg/dL) at 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.
Patient Continuation and Safety: A significantly high percentage of patients (89%) have continued into the extension phase of the study, an 18-week treatment period, suggesting that CardiolRx™ is well-tolerated. The study also confirmed that CardiolRx™ was found to be safe and well tolerated, with no significant adverse effects.
David Elsley, President & CEO of Cardiol Therapeutics, expressed optimism about the potential of CardiolRx™ as a non-immunosuppressive therapeutic option for pericarditis. Mr. Elsley highlighted the drug’s comparable efficacy to existing biologic therapies used in third-line treatment of recurrent pericarditis:
“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, and remarkably, these reductions are comparable in magnitude to biologic therapy commonly used in third-line treatment of recurrent pericarditis. Based on the clinically meaningful impact of CardiolRx™ on the key symptom of this debilitating disease, we now anticipate that the totality of the MAvERIC-Pilot data will support advancing to a Phase III trial of CardiolRx™ designed to meet our objective of providing an accessible and non-immunosuppressive therapeutic option for thousands of pericarditis patients.”
Recurrent pericarditis, a persistent inflammation of the pericardium – the protective membrane surrounding the heart – often resurfaces following an initial episode, frequently linked to viral infections. This condition is marked by intense chest pain, shortness of breath, and debilitating fatigue, which results in significant physical limitations and a diminished quality of life for patients. With an estimated 38,000 patients in the U.S. experiencing at least one recurrence annually, and many suffering for years, the need for effective treatments is critical. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than two years, and one third are still impacted at five years. Moreover, the progressive accumulation of pericardial fluid and subsequent scarring can escalate to a life-threatening constriction of the heart, highlighting an urgent need for advancements in medical treatment and patient care protocols.
The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and primarily used as a third-line intervention. However, CardiolRx™’s tolerability and side effect profile is expected to be much more favourable than the current treatment – which has risks typical of immunosuppressants. The economic burden is notable, with frequent emergency room visits and hospitalizations driving up healthcare costs. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay, and the cost per stay is estimated to range between $20,000 and $30,000 in the United States.
Building on the impressive topline results from the MAvERIC-Pilot study, Cardiol Therapeutics is poised to provide patients with an accessible and non-immunosuppressive treatment option for recurrent pericarditis, potentially surpassing existing therapies. These encouraging outcomes set the stage for a forthcoming Phase III trial, aiming to further validate the efficacy and safety of CardiolRx™, as Cardiol Therapeutics progresses towards commercialization.
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