Cardiol Therapeutics Announces it has Exceeded 50% Enrollment in its Phase II ARCHER Trial in Acute Myocarditis

Rhea-AI Summary

Cardiol Therapeutics Inc. (CRDL) exceeds 50% patient enrollment for ARCHER, a Phase II trial investigating CardiolRx™ for acute myocarditis treatment.

Insights

Medical Research Analyst

The enrollment milestone achieved by Cardiol Therapeutics in their ARCHER trial is a significant step forward in the clinical development landscape for acute myocarditis treatments. The focus on anti-inflammatory and anti-fibrotic therapies, such as CardiolRx™, is particularly noteworthy given the absence of FDA-approved treatments for this condition. The trial's design, which includes advanced cardiac magnetic resonance imaging to measure left ventricular function and myocardial edema/fibrosis, offers a robust method for assessing the drug's efficacy. These measures are critical as they are predictive of the long-term prognosis in acute myocarditis patients. The inclusion of multiple international research centers broadens the demographic and genetic diversity of the patient population, which can enhance the validity and applicability of the trial results.

From a medical research perspective, the successful completion of this trial could lead to a better understanding of the therapeutic potential of CardiolRx™ and potentially provide a new standard of care for a disease with significant morbidity and mortality. Additionally, the trial's outcomes could pave the way for orphan drug designation, which would offer a pathway for expedited development and exclusive marketing rights, thus incentivizing further investment in this therapeutic area.

Health Economist

The economic implications of developing a successful treatment for acute myocarditis are substantial. With an average hospital stay costing approximately $110,000 in the United States and a 4 - 6% risk of in-hospital mortality, the burden on the healthcare system is notable. An effective therapy could reduce hospitalization time and improve patient outcomes, leading to significant cost savings. Moreover, the potential for orphan drug designation could result in prolonged market exclusivity and fee exemptions, enhancing the commercial viability of CardiolRx™ for Cardiol Therapeutics.

Furthermore, the drug's progress in clinical trials may have positive implications for the company's market valuation, as investors often respond favorably to successful trial milestones. The orphan drug status could also lead to accelerated regulatory review, which, combined with the incentives provided, could substantially shorten the time to market and reduce development costs, creating a favorable economic environment for Cardiol Therapeutics.

Financial Analyst

For investors and stakeholders, the announcement of surpassing 50% patient enrollment in the ARCHER trial is a strong indicator of Cardiol Therapeutics' progress and potential growth. Achieving this milestone is likely to be viewed positively by the market, as it reflects the company's ability to execute its clinical development plans effectively. The trial's success could lead to a significant upside for the company's stock, given the high cost of treatment and the current lack of approved therapies for acute myocarditis.

Investors should also consider the strategic implications of the trial's international scope. By conducting research across diverse geographical locations, Cardiol Therapeutics may be positioning itself for global market penetration, which could further enhance the company's growth prospects. However, it is important to remain cautious until the final trial results are released, as positive outcomes are not guaranteed and the drug's safety and efficacy are still under evaluation.

Toronto, Ontario--(Newsfile Corp. - January 9, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that it has exceeded 50% patient enrollment for ARCHER, the Company's Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial investigating the safety, tolerability, and impact of CardiolRx™ on myocardial recovery in patients presenting with acute myocarditis.

"Achieving this milestone reflects the commitment and interest demonstrated by our clinical collaborators and participating patients, and we thank them for their contribution to the progress being made in this important clinical trial," said David Elsley, Cardiol Therapeutics' President and Chief Executive Officer. "Acute myocarditis is an inflammatory heart disease that impairs heart function, is associated with symptoms that can seem like a heart attack, is an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. Results from the ARCHER trial will assist in further understanding the therapeutic potential of CardiolRx™ and will complement the important clinical data from our ongoing MAvERIC-Pilot Phase II study in patients presenting with recurrent pericarditis."

The ARCHER trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence. The trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in North America, France, Brazil, and Israel. The primary outcome measures of the trial, which will be evaluated following 12 weeks of double-blind therapy, consist of two cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. Additional efficacy outcome measurements include survival, freedom from major cardiovascular events, resolution of clinical symptoms, and change in biomarkers associated with cardiac function and inflammation.

Myocarditis is an acute inflammatory condition of the heart muscle (myocardium) characterized by chest pain, shortness of breath at rest or during activity, fatigue, rapid or irregular heartbeat (arrhythmias), and light-headedness or feeling one might faint. Although the symptoms are often mild, many patients will also report flu-like symptoms such as headache, body aches, joint pain, fever or sore throat prior to disease onset. Viral infection is the most common cause of myocarditis; however, this disease can also result from bacterial infection and commonly used drugs and mRNA vaccines, as well as therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors.

There are no FDA-approved therapies for acute myocarditis. Patients hospitalized with the condition experience an average 7-day length of stay and a 4 - 6% risk of in-hospital mortality, with average hospital charge per stay estimated at $110,000 in the United States. Cardiol believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States and the European Union. Orphan drug designation programs were established to provide life sciences companies with incentives to develop new therapies for rare diseases. These incentives include periods of prolonged marketing exclusivity and exemptions from certain fees. Products with orphan drug designation also frequently qualify for accelerated regulatory review.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.

Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age.

Cardiol is also developing a novel subcutaneously administered drug formulation of cannabidiol intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.

For more information about Cardiol Therapeutics, please visit cardiolrx.com.

Cautionary statement regarding forward-looking information:

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 relating to the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical study and trial activities and timelines associated with such activities, the Company's plan to advance the development of a novel subcutaneous formulation of CardiolRx™ for use in heart failure, and details as to how the results of the ARCHER Trial and MAvERIC Pilot Study will be used going forward. 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 Report on Form 20-F dated March 28, 2023, 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.

For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/193615

FAQ

What is the purpose of the ARCHER trial by Cardiol Therapeutics Inc. (CRDL)?

The ARCHER trial is a Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial investigating the safety, tolerability, and impact of CardiolRx™ on myocardial recovery in patients presenting with acute myocarditis.

What are the primary outcome measures of the ARCHER trial?

The primary outcome measures consist of two cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis.

What are the symptoms and causes of myocarditis?

Myocarditis is characterized by chest pain, shortness of breath, fatigue, rapid heartbeat, and light-headedness. Viral infection is the most common cause, but it can also result from bacterial infection, commonly used drugs, mRNA vaccines, and cancer therapies.

What is the significance of developing a therapy for acute myocarditis?

There are no FDA-approved therapies for acute myocarditis, and patients hospitalized with the condition experience a 4 - 6% risk of in-hospital mortality, with an average hospital charge per stay estimated at $110,000 in the United States.

What are the potential benefits of an orphan drug designation for CardiolRx™?

An orphan drug designation would provide Cardiol Therapeutics with periods of prolonged marketing exclusivity, exemptions from certain fees, and accelerated regulatory review for CardiolRx™ as a new therapy for acute myocarditis.