Biotech Initiates Phase III Trial for Heart Disease Drug

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Clinical-stage life sciences company Cardiol Therapeutics (CRDL:TSX; CRDL:NASDAQ) announced results from its Phase II MAvERIC-pilot study investigating its drug CardioRx administered to patients with symptomatic recurrent pericarditis.

The data showed that marked improvements in both pericarditis pain and inflammation, previously reported at the eight-week primary endpoint, were maintained throughout the extension period of the 26-week study, the company said in a release.

"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," said Dr. S. Allen Luis, co-director of the Pericardial Diseases Clinic and associate professor of medicine in the Department of Cardiovascular Medicine at the Mayo Clinic, who presented the data in a lecture to the American Heart Association.

Pericarditis refers to "inflammation of the pericardium (the membrane or sac that surrounds the heart) frequently resulting from a viral infection," the company said. "Following that initial episode, patients may have multiple recurrences, and the primary goal of treatment is recurrence prevention."

The MAvERIC-Pilot study enrolled 27 participants (average age 53 years; 67% female) at eight clinical sites across the United States. Average disease duration and the number of pericarditis episodes per year prior to trial entry were 2.7 years and 5.8 events per year, respectively.

According to Cardiol, the findings support the initiation of a phase III trial (MAVERIC-3) designed to assess CardiolRx for the treatment of pericarditis patients to prevent recurrence. The MAVERIC-3 trial is expected to run in parallel with the recently announced MAVERIC-2 phase II/III trial designed to evaluate the impact of CardiolRx in recurrent pericarditis patients following cessation of interleukin-1 blocker therapy.

"In addition, results demonstrated a substantial reduction in pericarditis episodes per year as compared to the patients' historical event rate prior to the study," Luis said. "Importantly,

treatment was shown to be safe and well tolerated in a population who presented with significant disease burden."

Advancing Studies 'Aggressively'

In a research note dated November 19, the day after Cardiol's release, Leede Financial Inc. analyst Dr. Douglas Loe maintained his Speculative Buy rating on Cardiol CA$11.00.

Loe highlighted the sustained efficacy of CardiolRx, stating, "CardiolRx-treated patients exhibited sustained pain relief (using the eleven-point numerical rating scale [NRS]) out to at least six months, with average pain score at enrollment of 5.8 for all 27 patients declining to 1.5 at 6-month analysis."

The analyst emphasized the drug's performance compared to existing treatments, noting, "MAvERIC eight-week NRS data actually compares favorably to rilonacept's NRS data at the equivalent timepoint in RHAPSODY." He added that "CardiolRx also performs well on normalizing circulating CRP levels, though not quite as rapidly as rilonacept did in RHAPSODY."

In a research note dated November 19, the day after Cardiol's release, Leede Financial Inc. analyst Dr. Douglas Loe maintained his Speculative Buy rating on Cardiol CA$11.00.

"We endorse Cardiol's decision to advance aggressively into two Phase II/III follow-on recurrent pericarditis studies, one of which will be the 110-patient MAvERIC-2 trial that will exclusively enroll patients previously treated with but have discontinued rilonacept," Loe wrote.

The analyst wrote, "At current levels, our PT corresponds to a one-year return of 333%, and we believe MAvERIC data have sufficiently de-risked CardiolRx’s clinical profile in cardiac inflammation pathologies to a degree that we encourage diversified healthcare-focused investors to augment CRDL holdings at current levels."

Analyst Vernon Bernardino of H.C. Wainwright & Co., in a research note October, wrote that results from MAVERIC-2 could "potentially be a positive catalyst in 2H25." Bernardino rated the stock Buy with a US$9 per share target price.

Jason Wittes, an analyst with Roth MKM, also rated the stock Buy, but with a US$10 per share 12-month price target.

Wittes noted an 18-week extension cohort in the new data "showed remarkable durability."

"With the recent equity raise, the company has enough cash on hand to fund operations through mid-2026," Wittes wrote.

The Catalyst: A Growing Market

According to Precedence Research, the global market for cardiovascular drugs was valued at US$144.11 billion in 2023 and is poised to grow from US$149.99 billion in 2024 to US$207.78 billion by 2033, growing at a CAGR of 4% from 2024 to 2033.

"The cardiovascular drugs market is experiencing noteworthy growth, driven by the increasing prevalence of heart-related conditions such as arrhythmias, coronary artery disease, hypertension, and heart failure," Precedence researchers wrote. "The rising demand for effective treatments addressing different mechanisms of action (in the heart) is driving economic growth, making cardiovascular medicine a grounding of modern medicine."

The top cardiovascular disease drug in 2023, Eliquis by Bristol Myers Squibb and Pfizer, brought in nearly US$12 billion in sales in 2022.

Ownership and Share Structure

According to Refinitiv, about 4.5% of the company is held by insiders and management and 9.5% by institutions. The rest is retail.

Top shareholders include Tejara Capital Ltd. at 2.17%, Merlin Asset Management at 1.97%, President David Elsley at 1.48%, AdvisorShares Investments LLC at 1.43%, and Michael Willner at 1.06%.

The company has 81.6 million shares outstanding with 77.96 free float traded shares. Its market cap is CA$205.64 million and it trades in a 52-week range of CA$1.07 and CA$4.26.