Cardiol Therapeutics CEO: Phase III MAVERIC Nears Full Enrollment as CardiolRx Shows Myocarditis Promise

Key Points

• Phase III MAVERIC in recurrent pericarditis is past 50% enrollment and is expected to reach full enrollment this quarter, with the FDA having sanctioned the study as a pivotal trial to support a new drug application.
• ARCHER myocarditis data showed structural improvement and reduced swelling/edema, suggesting CardiolRx may provide a non–immune‑suppressing treatment option in a condition that currently has no approved standard of care.
• Cardiol is developing CRD‑38 as a once‑monthly reformulation, holds a broad U.S. patent on CardiolRx/CRD‑38 through 2040, and reports a cash runway into the end of 2027 while pursuing licensing partnerships for commercialization.

Cardiol Therapeutics NASDAQ: CRDL is aiming to address inflammation-driven heart disease with therapies the company believes could improve outcomes in conditions that currently have limited or no approved treatment options, President and CEO David Elsley said in an interview with Barchart.

Speaking with Barchart Head of Content Kinsey Grant Baker, Elsley described Cardiol’s focus in simple terms as targeting “inflammation and how it impacts quality of life and the lives of tens of thousands of people around the world who live with or die from heart disease.”

2023 updates: late-stage transition and two major programs

Elsley characterized 2023 as “a transformational year” for Cardiol, saying the company moved into late-stage development. He highlighted three areas of progress:

• Initiation of the Phase III MAVERIC program in recurrent pericarditis
• Reported data from the global ARCHER trial in myocarditis
• Advancement of what he described as a “new novel concept” with potential applications in broader heart disease, including heart failure

According to Elsley, the company’s lead drug candidate CardiolRx is being studied across both recurrent pericarditis and myocarditis, conditions he said can significantly impair quality of life and, in some cases, lead to serious outcomes.

MAVERIC: Phase III pivotal trial in recurrent pericarditis

Elsley said Cardiol met with the U.S. Food and Drug Administration early last year and that the MAVERIC study was “sanctioned a pivotal trial.” He described recurrent pericarditis as a “miserable condition” that can include chest pain and shortness of breath and can affect people “in their prime of life,” including patients in their mid-40s to 50s.

The company has said it surpassed 50% enrollment and expects full enrollment this quarter. Elsley told Barchart that patients are enrolling at “preeminent cardiovascular research centers throughout the United States,” including Cleveland Clinic and Mayo Clinic, which he called the largest pericardial disease centers in the world.

He added that the Phase III pivotal trial is designed to generate information to support a new drug application and that Cardiol believes CardiolRx could be “effective, safe, and accessible, and affordable” for patients. He also said reaching 50% enrollment is typically a key momentum point in trials, as the study infrastructure is fully established and enrollment can accelerate from there.

ARCHER: myocarditis data and implications

Elsley also discussed data from the ARCHER program in myocarditis, calling it “a landmark study” and “one of the largest company-sponsored studies of its time.” He noted myocarditis is “the leading cause of sudden cardiac death in young people under the age of 35” and said there is currently “no standard of care,” with no drug labeled for treatment of myocarditis.

He said data were presented at the European Society of Cardiology meeting in late November and referenced a company press release on Dec. 1. Elsley said the data were presented by Dr. Les Cooper, whom he identified as Head of the Mayo Clinic and Founder of the Myocarditis Foundation. According to Elsley, the results showed “structural improvement and reduction in swelling and edema in inflamed hearts,” which he described as analogous to effects observed with “many blockbuster medications” in other cardiovascular areas.

CRD-38 and the company’s inflammation thesis

Beyond CardiolRx, Elsley outlined the company’s work on CRD-38, which he described as a reformulation or “new generation” of the lead product. He said CardiolRx is a “twice-daily oral” therapy intended for use in more acute phases of disease, while CRD-38 was designed with a more efficient dosing schedule that “offers the potential for a once-monthly therapy.”

Elsley said CRD-38 could be relevant for large patient populations, including heart failure. He described heart failure as “an epidemic of sorts,” driven by diabetes, obesity, and high blood pressure, and said it affects millions of people. He also noted that heart failure “still has a 50% five-year mortality rate” and is a leading cause of hospital admission.

Discussing why inflammation is a major theme, Elsley said persistent or unmanaged inflammation can damage heart cells and lead to fibrosis, which can reduce the heart’s ability to function normally. He said many historical anti-inflammatory strategies are immune-suppressing and can raise infection risk with prolonged use. By contrast, he said Cardiol is developing drugs that are “not immune-suppressing” and offer “an improved safety profile,” while also providing oral convenience compared with injectable immune suppressants.

Elsley also contrasted Cardiol’s approach with certain biologic therapies used in advanced pericarditis, which he said can be “very expensive.” He cited one drug with “a list price of over CAD 300,000 per year per patient,” arguing such costs can limit reimbursement and access.

Patent protection, partnering strategy, and funding runway

Cardiol recently received a broad U.S. patent covering CardiolRx and CRD-38 through 2040, Baker noted. Elsley said intellectual property protection is important to establish “barriers to competitive entry” and generate returns that can fund further research.

He also described Cardiol as a drug discovery and development company that intends to take candidates through clinical demonstration and then license them to larger pharmaceutical or biotechnology companies with established commercialization capabilities. Elsley said the company was pleased with the scope of the newly awarded U.S. patent, which he said was broader than expected and covers “the entire cardiovascular landscape.”

He added that Cardiol also has orphan designation from the FDA, which he said provides market exclusivity periods “seven to nine years post-commercialization” and can help speed drug development.

Asked about a recent Canaccord Genuity buy rating and an $8 price target mentioned by Baker, Elsley pointed to MyoKardia as an example of how a rare cardiac-disease developer could build value through partnering and eventual acquisition. He said he believes Cardiol is “deeply undervalued and under-recognized.” He also stated the company has a cash runway “into really the end of 2027,” adding that Cardiol is funded for 2024 and positioned to pursue strategic alliances for commercialization.

Looking ahead, Elsley said 2024 is set to be “an extremely exciting year,” and emphasized Cardiol’s work with cardiovascular specialists to improve outcomes for patients whose lives are affected or threatened by heart disease.

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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