Cardiol Therapeutics Advances CardiolRx in Pivotal Phase III Pericarditis Trial

Key Points

• Cardiol Therapeutics is advancing CardiolRx into the pivotal Phase III MAVERIC trial for preventing recurrent pericarditis, targeting patients discontinuing the IL-1 inhibitor rilonacept.
• The company expects recurrence in roughly 75% of placebo patients within two to three months after rilonacept withdrawal and has designed the study to detect a 40% relative risk reduction over six months.
• If successful, Cardiol believes CardiolRx could support a broader prevention label and compete as an oral, non-immunosuppressive alternative to biologic therapies; management estimates potential pricing of up to 60% of rilonacept’s cost.

Cardiol Therapeutics NASDAQ: CRDL is advancing its synthetic, pharmaceutical-grade cannabidiol formulation, CardiolRx, in a pivotal Phase III trial for recurrent pericarditis, with management describing the program as a key step toward a potential new drug application.

Speaking at a Canaccord Genuity event, Chief Medical Officer Andrew Hamer said the company developed its cannabidiol formulation based on evidence of anti-inflammatory activity, particularly in cardiovascular diseases. The company’s lead clinical program, CardiolRx, is being evaluated in the MAVERIC Phase III trial for prevention of recurrent pericarditis.

MAVERIC Focuses on Patients Discontinuing Rilonacept

The MAVERIC study is enrolling patients who have received the IL-1 inhibitor rilonacept for more than one year and are planning to discontinue treatment. Hamer said this population was selected because it represents an unmet need and is expected to have a high rate of recurrent disease after stopping rilonacept.

“Nothing has been shown to help them get off immunosuppression,” Hamer said, describing CardiolRx as an oral, non-immunosuppressive treatment candidate.

According to Hamer, the company expects the placebo group to experience a recurrence rate of approximately 75% within two to three months after rilonacept discontinuation. MAVERIC has been powered to detect a 40% relative risk reduction. Using the company’s assumptions, a 75% placebo recurrence rate and a 45% active-treatment recurrence rate would meet that threshold.

The trial’s primary endpoint is recurrence of pericarditis over six months. Participants remain on rilonacept for at least 10 to 16 days after starting either CardiolRx or placebo, creating an overlap period before rilonacept is withdrawn.

Hamer compared the design with the Phase III RHAPSODY trial of rilonacept, in which patients whose recurrent pericarditis had stabilized on rilonacept were randomized either to continue therapy or switch to placebo. Cardiol’s study similarly evaluates recurrence after rilonacept withdrawal, although its participants have been stable on the IL-1 blocker for a longer period, he said.

“It’s a very clean population,” Hamer said, noting that trial participants previously failed colchicine and are not using NSAIDs or corticosteroids when they enter the study.

Phase II Results and Potential Label

Cardiol’s earlier open-label Phase II study used pain as its primary endpoint during acute pericarditis episodes. Hamer said an extension phase also assessed recurrence rates among patients who transitioned to CardiolRx monotherapy.

He said 71% of patients remained recurrence-free during that period. Management compared patients’ historical annualized event rate of 5.8 episodes before CardiolRx with 0.9 episodes per year while on CardiolRx monotherapy. Hamer emphasized that those findings relied on historical comparisons, while MAVERIC includes a placebo arm intended to provide controlled evidence of benefit.

CEO and President David Elsley said the company expects that, if the trial meets its objectives, a potential label could cover prevention of recurrence rather than being limited to patients discontinuing rilonacept. He said Cardiol’s discussions with regulators have supported the view that the underlying biology of recurrence is similar across patient groups, including those stopping IL-1 blockers, experiencing a first recurrence, or not responding to other therapies.

Commercial Positioning and Pricing Work

Management said discussions with key opinion leaders have suggested CardiolRx could potentially be used after first-line treatment, particularly for patients who cannot tolerate or do not respond to NSAIDs or colchicine. Elsley said the company sees the oral administration and non-immunosuppressive profile as potential advantages relative to biologic therapies.

He also said some patients do not tolerate colchicine because of gastrointestinal effects, potentially creating an opportunity for an alternative oral treatment.

Cardiol has not established a price for CardiolRx. Elsley said the company will await Phase III results before finalizing pricing work, though it has conducted payer research. He said payers indicated potential pricing could reach as much as 60% of the price of rilonacept, which he identified as the incumbent therapy.

For commercialization, Elsley said specialty pharmacies would likely be an important distribution channel because recurrent pericarditis treatment is concentrated among specialized practices. Cardiol is also considering commercial partnerships, a tactical sales force and other options, while keeping its immediate focus on completing MAVERIC.

Other Cardiovascular Programs

Management also discussed its subcutaneous formulation, CRD-38, which the company has identified for potential development in heart failure with preserved ejection fraction. Hamer said Cardiol believes there is a need for non-immunosuppressive approaches in heart failure, where infections can complicate patients’ condition.

Elsley said findings from the company’s ARCHER myocarditis trial, including an observed effect on left ventricular mass, could have implications for its heart-failure development strategy. He characterized myocarditis as a potential clinical proxy for evaluating the effects of the company’s subcutaneous formulation in heart failure.

About Cardiol Therapeutics (NASDAQ:CRDL)

Cardiol Therapeutics Inc NASDAQ: CRDL is a clinical-stage pharmaceutical company dedicated to developing immunomodulatory treatments for patients with cardiovascular disease. The company's lead asset, CardiolRx, is a proprietary, pharmaceutical-grade cannabidiol (CBD) formulation designed to target the inflammation and oxidative stress underlying conditions such as acute myocardial injury and heart failure. Cardiol holds exclusive global rights to CardiolRx through a licensing partnership and is advancing additional preclinical programs focused on small-molecule immunotherapies for heart disease.

CardiolRx is formulated for oral administration and has been evaluated in a randomized, placebo-controlled Phase 2 myocardial protection study assessing safety and key biomarkers following acute coronary syndromes.

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