Cardiol Therapeutics (NASDAQ:CRDL) used a presentation at TD Cowen’s 46th Annual Healthcare Conference to outline its clinical development programs targeting inflammation in cardiac disease, with its most advanced asset, CardiolRx, currently being studied in a Phase III trial for recurrent pericarditis.
Focus on inflammation across cardiac indications
CEO David Elsley said the company is focused on inflammation as a disease-driving mechanism in heart disease, with late-stage development in orphan indications and earlier-stage work aimed at larger markets such as heart failure. Elsley described recurrent pericarditis as the company’s primary near-term focus and framed the opportunity as a potential “billion-dollar” market for a new entrant that could offer an oral option with a non-immunosuppressive profile and improved accessibility.
MAVERIC Phase III in recurrent pericarditis: design and timeline
Elsley said CardiolRx is being evaluated in the Phase III MAVERIC study in recurrent pericarditis, with enrollment described as accelerating across “preeminent cardiovascular research centers” in the U.S., as well as sites in Europe and Canada. He also noted that the U.S. Food and Drug Administration has granted Orphan Drug Designation for the broader pericarditis landscape.
He characterized recurrent pericarditis as a condition affecting patients “in their prime of life,” with severe chest pain, shortness of breath, and quality-of-life impairment that can persist for years. In describing the treatment landscape, Elsley said first-line therapy typically includes non-steroidal anti-inflammatory drugs and colchicine, but that thousands of patients annually do not respond or cannot tolerate these options. He said next-line approaches include corticosteroids, which he associated with toxicity and dependency, and biologic therapies that may be immunosuppressive, expensive, and administered by injection.
Elsley outlined MAVERIC’s approach as an “enrichment” strategy designed to increase the expected recurrence rate in the placebo group by enrolling high-risk patients. According to Elsley, the trial brings patients in on stable interleukin-1 (IL-1) blockade, randomizes them to CardiolRx or placebo, and then withdraws IL-1 therapy. He cited evidence suggesting recurrence rates can be as high as 75% within three months for this patient population after IL-1 withdrawal, which he said informs expectations for the placebo arm during the 24-week treatment period.
On timing, Elsley said the company expects to complete enrollment by the end of the second quarter and said this could support a top-line readout in the back half of the year.
Phase II results highlighted: pain, inflammation marker, and recurrences
Elsley reviewed results from a Phase II study that he said was modeled after the development path used for biologics in recurrent pericarditis. The study included eight centers, including Cleveland Clinic and Mayo Clinic, and evaluated changes in pericarditis pain as the primary endpoint at eight weeks, with additional assessments out to 26 weeks as well as measures of recurrence and inflammatory biomarkers.
He said patients entered the study on stable background therapy (colchicine, non-steroidals, and/or steroids) but still had substantial pain, with baseline pain described as roughly 6 out of 10 on an 11-point numeric pain scale. Elsley said pain improved to a “manageable or undetectable” level within two weeks and that this was sustained at eight weeks. He added that 24 patients (about 90% of those eligible) entered an extension phase, during which background medications were withdrawn down to CardiolRx monotherapy while pain control was maintained.
Elsley also discussed C-reactive protein (CRP), describing baseline levels as about four times normal and saying CRP approached normal at eight weeks and reached the normal range by 26 weeks even as background medications were withdrawn.
In addition, he highlighted a reduction in pericarditis events per year, from 5.8 at baseline to 0.9 during the study, and said 71% of patients remained recurrence-free during the trial.
- Pain: rapid improvement within two weeks, sustained through follow-up described.
- CRP: reduced from elevated baseline toward normal ranges over time.
- Recurrence: events per year reduced and a majority of patients recurrence-free during the study.
ARCHER myocarditis data: imaging endpoints and LV mass
Elsley also discussed results from the global ARCHER trial in myocarditis, which he called an underserved indication with no standard of care and a condition he said is a leading cause of sudden cardiac death in young people. He described myocarditis as associated with costly hospital admissions and potential progression to heart failure or, in severe cases, transplant.
According to Elsley, ARCHER enrolled 109 patients across five countries, using cardiac MRI and Lake Louise Criteria for diagnosis. Patients were randomized 1:1 to placebo or CardiolRx for 12 weeks, with baseline and follow-up imaging to evaluate markers including extracellular volume, intracellular volume, and left ventricular (LV) mass.
Elsley reported a “notable trend to significance” for reduction in extracellular volume and a directional impact on intracellular volume. He emphasized a “highly significant” 9.2-gram reduction in LV mass over 12 weeks, which he compared to LV mass changes reported with other drug classes over longer durations. He said the company views these findings as evidence of structural improvement in myocarditis and as supportive of broader development opportunities, including potential additional orphan targets and a translational bridge to earlier preclinical work.
Positioning and next steps, including heart failure
In Q&A, Elsley said key opinion leaders would be “thrilled” with a 35% to 40% reduction in recurrence rates in MAVERIC, noting that the Phase II program reduced recurrence by 70% and that the Phase III study is “conservatively powered.” He also said the company’s chemistry, manufacturing, and controls (CMC) readiness is “in very good shape,” adding that Cardiol has a long-standing GMP manufacturing partner and can scale to commercial production.
When asked about how physicians may place CardiolRx in the treatment algorithm, Elsley said the company’s discussions with clinicians suggest interest in a non-immunosuppressive, more accessible option that could help avoid corticosteroids and address dependency concerns tied to both steroids and IL-1 blockers. He described a potential sequencing in which NSAIDs and colchicine remain first-line, CardiolRx could be second-line, and IL-1 blockers could be used for patients who fail earlier steps.
Looking beyond CardiolRx, Elsley highlighted the company’s next-generation subcutaneous formulation, CRD-38, which he said could potentially enable a more efficient dosing schedule, “perhaps as efficient as once monthly,” and could be aimed at heart failure—an area he described as an “epidemic” driven by obesity, diabetes, and hypertension. He said heart failure still carries a 50% five-year mortality rate, underscoring the need for new therapies, and added that the company is seeing increased attention from potential strategic partners for its heart failure program.
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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