Full Press Release Details
Cardiol Therapeutics Expands U.S. MAVERIC Phase
III Trial Network to Address Growing Interest in the Pivotal Program
TORONTO, April 28, 2026 /CNW/ - Cardiol Therapeutics
Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a late-stage life sciences company advancing
anti-inflammatory and anti-fibrotic therapies for heart disease, today announced the continued expansion of its pivotal Phase III MAVERIC
trial in the United States ("U.S."), with the planned activation of up to seven additional clinical centers. Patient enrollment
in MAVERIC surpassed the 50% threshold in early January and has now reached 75%. Target recruitment is anticipated by the end of Q2 2026,
with the potential to extend into Q3 to accommodate patient enrollment from additional clinical sites.
"Broadening the MAVERIC clinical site network
reflects the strong interest we have received from leading clinical centers across the United States and underscores the level of investigator
conviction in both the therapeutic rationale and the unmet need in recurrent pericarditis," said David Elsley, President and Chief
Executive Officer of Cardiol Therapeutics. "The participation of multiple premier cardiovascular research institutions gives us confidence
that MAVERIC will generate a robust dataset to define the clinical profile of CardiolRx and support its potential as a non-immunosuppressive
oral, more accessible therapy earlier in the treatment pathway."
MAVERIC Phase III Trial
MAVERIC is a randomized, double-blind, placebo-controlled
pivotal Phase III trial evaluating CardiolRx for the prevention of disease recurrence in patients with recurrent pericarditis.
The study is designed to enroll approximately 110 patients. MAVERIC was designed with input from the U.S. Food and Drug Administration
("FDA"), with alignment on trial design achieved at an end-of-Phase II meeting in April 2025. The first patient was randomized
at Northwestern University in April 2025.
MAVERIC builds on the clinical evidence established
in the Phase II MAvERIC study, which demonstrated that CardiolRx produced rapid and sustained reductions in pericarditis
pain and inflammation, along with a substantial decrease in recurrent episodes per year. These findings, presented at the American Heart
Association Scientific Sessions 2024, provide a compelling clinical and mechanistic foundation for the ongoing pivotal Phase III program
and support the potential for CardiolRx to address a significant unmet need in recurrent pericarditis.
Pericarditis refers to inflammation of the pericardium
(the membrane or sac that surrounds the heart), which frequently results from a viral infection. Patients may have multiple recurrences
following that initial episode, and the primary goal of treatment is recurrence prevention. Symptoms include debilitating chest pain,
shortness of breath and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations.
Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. On an annual basis,
the number of patients in the United States experiencing at least one recurrence is estimated at 40,000. Approximately 60% of patients
with more than one recurrence suffer for more than two years, and one third remain impacted at five years. Hospitalization due to recurrent
pericarditis is typically associated with a 6-8-day stay and cost per stay is estimated to range between $20,000 and $30,000 in the United
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL)
is a late-stage life sciences company focused on advancing the development of anti-inflammatory and anti-fibrotic therapies for heart
disease. The Company's lead small-molecule drug candidate, CardiolRx , modulates inflammasome pathway activation, an intracellular
process known to play an important role in the development and progression of inflammation and fibrosis associated with pericarditis,
myocarditis, and heart failure.
The MAVERIC Program is evaluating CardiolRx
for the treatment of recurrent pericarditis, an inflammatory disease of the pericardium associated with symptoms including debilitating
chest pain, shortness of breath, and fatigue, which can lead to physical limitations, reduced quality of life, emergency department visits,
and hospitalizations. The program comprises the completed Phase II MAvERIC-Pilot study (NCT05494788) and the ongoing pivotal Phase III
MAVERIC trial (NCT06708299). The U.S. FDA has granted Orphan Drug Designation to CardiolRx for the treatment of pericarditis,
including recurrent pericarditis.
The ARCHER Program also studied CardiolRx ,
specifically in acute myocarditis - an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden
cardiac death in individuals under 35 years of age. The program comprises the completed Phase II ARCHER study (NCT05180240), which evaluated
the safety, tolerability, and efficacy of CardiolRx in this patient population.
The Company is also developing CRD-38, a novel, subcutaneously
administered drug formulation intended for the treatment of inflammatory heart disease, including heart failure - a leading cause of death
and hospitalization in the developed world, with associated healthcare costs in the United States exceeding US$30 billion per year.
For more information about Cardiol Therapeutics, please
visit cardiolrx.com.
Cautionary statement regarding forward-looking
This news release contains "forward-looking
information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address
activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are
"forward-looking information". Forward looking information contained herein may include, but is not limited to statements regarding
the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease; the Company's intended
clinical studies and trial activities and timelines associated with such activities, including the Company's plan to complete the Phase
III study in recurrent pericarditis with CardiolRx ; the Company's plan to advance the development of CRD-38, a novel
subcutaneous formulation intended for the treatment of inflammatory heart disease, including heart failure, including through the initiation
of a Phase I clinical program; the Company's belief that results from the ARCHER trial provide compelling clinical proof of concept for
CardiolRx and strengthen the scientific and clinical rationale for Cardiol's novel therapeutic approach for inflammatory
cardiac conditions, including its lead Phase III program in recurrent pericarditis; the Company's expectation that the Phase III MAVERIC
trial will reach full enrollment in Q2 2026 with the potential to extend into Q3 to accommodate patient enrollment from the additional
clinical sites; the Company's planned activation of up to seven additional clinical centers; the Company's expectation that MAVERIC will
support an NDA with the U.S. FDA; the Company's belief that the participation of multiple premier cardiovascular research institutions
gives it confidence that MAVERIC will generate a robust dataset to define the clinical profile of CardiolRx and support
its potential as a non-immunosuppressive oral, more accessible therapy earlier in the treatment pathway; and the Company's
ability to address its strategic priorities. Forward-looking information contained herein reflects the current expectations or beliefs
of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known
and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future
results, performance or achievements expressed or implied by the forward looking information, and are not (and should not be considered
to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred
to in the Company's Annual Information Form filed with the Canadian securities administrators and U.S. Securities and Exchange Commission
on March 31, 2026, available on SEDAR+ at sedarplus.ca and EDGAR at sec.gov, as well as the risks and uncertainties associated with product
commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and
investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes.
Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities
laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information,
future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements.
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SOURCE Cardiol Therapeutics Inc.
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CO: Cardiol Therapeutics Inc.
CNW 07:27e 28-APR-26