Cardiol To Advance CardiolRx To Phase III Trial Following Positive Results

FULL DISCLOSURE: This is sponsored content for Cardiol Therapeutics.

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has seen success under a phase II trial conducted on CardiolRx™, which is the company’s lead small molecule drug candidate. The drug is currently going through clinical trials for use in the treatment of heart disease, specifically recurrent pericarditis and acute myocarditis.

The successful results come from a phase II open-label MAvERIC-Pilot study, which was tasked with investigating the impact of CardiolRx™ in patients with symptomatic recurrent pericarditis. Data was released this morning from the phase II trial, which showed that marked improvements in pain and inflammation from pericarditis which was previously reported at the 8-week primary endpoint was maintained through the extension period of the 26-week study.

The findings support a planned Phase III trial, referred to as MAVERIC-3, which will be designed to assess CardiolRx™ for the treatment of pericarditis patients for the prevention of recurrence. The trial is slated to run concurrently with the MAVERIC-2 phase II/III trial, which will evaluate CardiolRx™ for use in recurrent pericarditis patients following cessation on interleukin-1 blocker therapy.

“The compelling results from MAvERIC-Pilot showed that CardiolRx™ resulted in marked and rapid reductions in pericarditis pain and inflammation in patients with a high degree of disease burden as well as a striking decrease in pericarditis episodes per year,” commented David Elsley, CEO of Cardiol Therapeutics.

The trial specifics

The trial saw 27 participants enrolled at eight clinical sites across the United States. The average disease duration for participants was 2.7 years, while the number of pericarditis episodes per year prior to the trial were 5.8 events, with baseline pain scores averaging 5.8 out of 10. C-reactive protein levels were said to average 2.0 mg/dL.

The study, at 26 weeks in length, saw an 8 week treatment period followed by an 18-week extension period. The treatment period saw CardiolRx™ added to baseline medications for recurrent pericarditis, while the extension period saw baseline medications weaned off to assess pericarditis recurrence while only receiving CardiolRx™.

Following the trial, the primary endpoint of patient-reported pericardial pain showed a mean reduction of 3.7, from 5.8 to 2.1 at week 8, with 93% of participants reporting a reduction in pain. Median time to resolution or near resolution of pain was measured as being just five days. Reduction in pain then further reduced to 1.5 at week 26, a mean reduction of 4.3 during the entire trial period.

C-reactive protein levels normalized at week 8 in 80% of patients that had a baseline level in excess of 1 mg/dL, with a mean reduction of 5.4 mg/dL being observed, dropping from 5.7 mg/dL to 0.3 mg/dL. The entire group of patients saw levels drop from 2.0 mg/dL at baseline to 0.74 mg/dL at week 8, and to 0.55 mg/dL at week 26.

Freedom from recurrence was maintained in 71% of participants during the extended period when CardiolRx™ was provided and participants were weaned off baseline medication. The number of pericarditis episodes per year was reduced from 5.8 prior to the study to just 0.9 during the study, with those of whom experienced a recurrence seeing a median time to an episode of 7.7 weeks.

Perhaps most importantly, CardiolRx™ was shown to be safe and well tolerated, with 89% of patients progressing to the extended period, and overall study drug compliance being reported as 95%.

The data in the press release was presented at the Laennec Clinician-Educator Award & Lecture at the American Heart Association Scientific Sessions 2024 by Dr S. Allen Luis, Co-Director of the Pericardial Diseases Clinic and an associate professor of medicine in the Department of Cardiovascular Medicine at the Mayo Clinic.

“The data reported today show that patients enrolled in MAvERIC-Pilot, despite the severity of their disease, experienced clinically relevant and rapid reductions in both their pericarditis pain and C-reactive protein levels that were maintained throughout the study. In addition, results demonstrated a substantial reduction in pericarditis episodes per year as compared to the patients’ historical event rate prior to the study,” commented Dr Luis on the results.

What is pericarditis?

Pericarditis is the inflammation of the pericardium, which is the sac that surrounds the heart, which results from a viral infection. Once an initial episode is experienced, patients may have several recurrences. 38,000 patients in the United States are estimated to experience a recurrence at least once a year. Symptoms of the disease are said to include shortness of breath and fatigue, and debilitating chest pain, which often results in reduced quality of life and physical limitations.

The disease can also lead to accumulation of pericardial fluid, while scarring can progress to life threatening constriction of the heart. It’s estimated that 60% of patients with multiple recurrences suffer for longer than two years, and one third are still impacted at five years.

The disease often results in frequent emergency department visits and hospitalizations, with hospital stays often being six to eight days in length, with those stays estimated to cost between $20,000 and $30,000 for each visit within the United States. The primary goal of treating pericarditis as a result is the prevention of recurrence.

The only drug currently approved for treatment of pericarditis is a costly therapy that was approved in 2021, which is primarily used as a third-line intervention. The implication here for CardiolRx™, is that the phase II trial demonstrates the potential for a more accessible, non-immunosuppressive oral medication for the tens of thousands of pericarditis patients.

“These results further support advancing our late-stage MAVERIC clinical development program comprising our recently announced Phase II/III MAVERIC-2 trial as well as our planned MAVERIC-3 Phase III trial. Undertaking both trials in parallel provides the exciting opportunity for CardiolRx™ to address the unmet needs of patients in multiple segments that encompass a broad proportion of the pericarditis population,” continued Elsley.

Cardiol Therapeutics last traded at $2.52 on the TSX.

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FULL DISCLOSURE: Cardiol Therapeutics is a client of Canacom Group, the parent company of The Deep Dive. Canacom Group is long the equity of Cardiol Therapeutics. The author has been compensated to cover Cardiol Therapeutics on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security.