Recurrent Pericarditis: Through the Eyes of the Physicians Treating It

Cardiol Therapeutics recently brought together the health care professionals running our pivotal trial for the MAVERIC Phase III Investigators’ and Study Coordinators’ Meeting in New York City. The clinicians in the room treat recurrent pericarditis in their own practices, and their account of the disease (and of what patients need from a new therapy) explains a great deal about why the trial is designed the way it is.

A disease that is hard to recognize

Pericarditis is inflammation of the pericardium, the thin, protective sac that surrounds the heart. Its defining symptom, sharp chest pain, is easily confused with a heart attack. Investigators describe patients who move between emergency departments and physicians’ offices for months before a specialist confirms the diagnosis.

One investigator described recurrent pericarditis as a disease that has fallen through the cracks, and one that no part of the medical system has fully taken ownership of.

The weight of recurrence

For too many patients, pericarditis comes back. Each recurrence can bring the same severe pain, another visit to emergency or urgent care and time lost from work and family.

Investigators note that the anxiety between episodes is part of the disease as well. Patients want to know when the next flare will arrive and whether they can do anything to prevent it. Many are young adults, and they are often told at diagnosis to expect the condition to last three to five years.

The clinical problem MAVERIC addresses

Treatment typically begins with anti-inflammatory medicines and colchicine and can progress to corticosteroids. For patients with multiple recurrences, physicians may turn to injectable interleukin-1 blocker therapy.

Investigators describe the difficulty that follows: patients may need to remain on that therapy for an extended period, because stopping it carries a high risk of recurrence. One investigator observed that in their own practice, nearly all patients recur once the therapy is stopped.

MAVERIC is designed to address this problem. The trial is evaluating CardiolRx™ for reducing the risk of pericarditis recurrence. It builds on the Phase II MAVERIC study, published in the Journal of the American Heart Association.

What patients and physicians are looking for

The investigators were consistent about what they want from a new therapy. Patients are looking for an option that is oral, accessible and safe to take over the long term. Physicians point to the side effects that make corticosteroids difficult to use for extended periods, and to the burden that injectable treatment places on patients. CardiolRx™ is an investigational oral, non-immunosuppressive therapy designed to act upstream in the inflammatory process, targeting the pathway that drives the disease without broadly suppressing the immune system.

Their goals for patients extend past symptom control. One investigator described wanting patients to come off treatment entirely and return to the lives they had before diagnosis, with time for family and the activities they enjoy.

Why the trial is expanding

MAVERIC was designed in collaboration with a Steering Committee comprising experts in pericarditis and clinical research to enroll 110 patients. Based on a recommendation from the Steering Committee, Cardiol recently expanded target enrollment to 150 after observing a lower event count  than originally anticipated. Because the trial is blinded, that event rate observation was pooled across all participants. It does not show how patients receiving CardiolRx™ are faring compared with those receiving placebo.

A trial that measures recurrence needs to observe enough recurrences to compare the two groups with confidence. Enrolling more patients is intended to give MAVERIC the statistical strength to produce a clear and definitive result. That matters because MAVERIC is designed to support a New Drug Application with the FDA, and clinicians emphasized the importance of a result that leaves no room for ambiguity.

Looking ahead

Cardiol is tracking to complete enrollment by the end of 2026, with topline data expected in mid-2027. CardiolRx™ holds FDA Orphan Drug Designation for pericarditis. The health care professionals who met in New York are the ones who will ultimately judge whether a new therapy belongs in their practice, and the video recorded at that meeting lets them describe the need in their own words.

Watch the MAVERIC investigator video: youtu.be/9pmbEMajlgs

CardiolRx™ is an investigational drug and has not been approved by the FDA or any other regulatory authority. Views expressed by investigators are their own.