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Cardiol’s study is expected to enroll 25 patients from leading pericarditis clinical centers in the United States. The study protocol was designed in collaboration with opinion leaders in the field of pericardial disease. The primary efficacy endpoint of the trial is the change from baseline to 8 weeks in patient-reported pericarditis pain using a numerical rating scale (NRS) at 11 dots. The NRS is a validated clinical tool used in multiple acute and chronic pain conditions, including previous studies of recurrent pericarditis. Secondary endpoints include pain score after 26 weeks of treatment and changes in C-reactive protein (CRP).

“We are delighted to have Dr. Klein bring his expertise and leadership to the Cardiol study, and his contributions to date with respect to protocol design and facilitating clinical trial site recruitment have been invaluable. commented Dr. Andrew Hamer, Cardiol’s Chief Medical Officer. “We believe there is a significant opportunity to develop a novel, well-tolerated oral therapy for the treatment of recurrent pericarditis to prevent multiple recurrences, for colchicine-refractory, intolerant and contraindicated patients, as well as patients steroid addicts. With IND clearance now in place, we look forward to expediting the initiation of this important study. We also plan to benefit from the clinical trial infrastructure already established for our multinational study in acute myocarditis, which is expected to begin patient recruitment imminently.

Pericarditis refers to inflammation of the pericardium – the membrane, or sac, that surrounds the heart. Symptoms include debilitating chest pain, shortness of breath, and fatigue, which lead to physical limitations, reduced quality of life, emergency room visits, and hospitalizations. Causes of pericarditis can include infection (eg, tuberculosis), systemic disorders such as autoimmune and inflammatory diseases, cancer, and post-cardiac injury syndromes. Based on time of presentation, acute pericarditis is a symptomatic event lasting less than four to six weeks, with diagnosis based on satisfaction of two of four criteria: chest pain; pericardial friction; changes in the electrocardiogram; and new or worsening pericardial swelling. The elevation of inflammatory markers such as CRP and the demonstration of pericardial inflammation by an imaging technique (computed tomography or cardiac magnetic resonance) can help in the diagnosis and monitoring of disease activity. Although usually self-limiting and not life-threatening, acute pericarditis is diagnosed in 0.2% of all cardiovascular hospitalizations and is responsible for 5% of emergency room admissions for chest pain in North America and Western Europe. .

Recurrent pericarditis is the recurrence of symptoms after an asymptomatic period of at least 4 to 6 weeks after an episode of acute pericarditis. These recurrences appear in 15 to 30% of acute cases and generally within 18 months. In addition, up to 50% of patients with a recurrent episode of pericarditis have more recurrences. Standard first-line medical treatment is nonsteroidal anti-inflammatory drugs or aspirin with or without colchicine. Corticosteroids such as prednisone are a second-line treatment in patients with ongoing recurrence and an inadequate response to conventional therapy. Recently, a potent subcutaneously injected interleukin-1 inhibitor was approved by the FDA for patients with recurrent pericarditis; however, this immunosuppressant is primarily used in patients with a third or fourth recurrence.

The U.S. Orphan Drug Designation Program was created to provide a drug sponsor with significant incentives, including seven-year market exclusivity and exemptions from certain FDA fees, to develop treatments for diseases that affect less than 200,000 people in the United States. Products with orphan drug designation are also often eligible for expedited regulatory review. The prevalence of recurrent pericarditis in the United States is estimated at 38,000. The program was successfully used to support the first FDA approval of cannabidiol for the treatment of rare pediatric epileptic syndromes. Cardiol believes there is a similar opportunity to develop its CardiolRx™ oral formulation as an orphan drug for the treatment of recurrent pericarditis.

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 cannabidiol as an anti-fibrotic and anti-inflammatory therapy for the treatment of cardiovascular disease (“CVD”). The Company’s lead product candidate, CardiolRx™, is a pharmaceutically produced oral formulation of cannabidiol that is in clinical development for use in cardiovascular medicine. CardiolRx™ is currently in evaluation in a multinational, phase II/III, randomized, double-blind, placebo-controlled study (the LANCER trial). LANCER is designed to evaluate the efficacy and safety of CardiolRx™ as a cardioprotective therapy to reduce major cardiovascular and respiratory events in patients hospitalized with COVID-19 who have a history or risk factors for CVD, and to study the influence CardiolRx™ has on key biomarkers associated with heart disease. Cardiol also received IND clearance from the FDA to conduct a multinational, randomized, double-blind, placebo-controlled, phase II trial designed to evaluate the efficacy and safety of CardiolRx™ in acute myocarditis (also a orphan indication), which remains an important cause of acute and fulminant heart failure in young adults and a major cause of sudden cardiac death in people under 35 years of age. Additionally, Cardiol is developing a subcutaneous formulation of CardiolRx™ for the treatment of cardiac fibrosis and inflammation associated with the development and progression of heart failure – a leading cause of death and hospitalization worldwide. developed, with associated healthcare costs in the United States exceeding $30 billion per year.

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

Caution Regarding Forward-Looking Information:

This press 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 or anticipates will, will or may occur in the future, is “forward-looking information”. Forward-looking information contained herein may include, but is not limited to, statements relating to the company’s intention that the pericarditis study be conducted in parallel with the company’s myocarditis trial, which should start shortly; the fact that the pericarditis study is designed to assess the tolerability and safety of CardiolRx; the fact that the pericarditis study will also assess improvement in objective measures of disease and assess the feasibility of weaning off concomitant disease-modifying therapy including corticosteroids while taking CardiolRx; that Allan L. Klein, MD, will serve as study chair and provide leadership throughout the trial; the possibility that CardiolRx™ may provide a treatment option in the patient population who are intolerant to current medical treatment or who require long-term administration of corticosteroids to control their disease; the expectation that the study will enroll 25 patients from leading pericarditis clinical centers in the United States; the expectation that Cardiol will now accelerate the initiation of the study; the belief that the study will benefit from infrastructure synergies, including streamlined procurement and site activation; the belief that there is a significant opportunity to develop a novel, well-tolerated and safe oral therapy for the treatment of recurrent pericarditis to prevent multiple recurrences, for colchicine-refractory, intolerant and contraindicated patients, as well as patients dependent on steroids; the belief that there is a similar opportunity to develop the Company’s CardiolRx™ oral formulation as an orphan drug for the treatment of recurrent pericarditis; the focus on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease; the completion of patient recruitment for the LANCER Phase II/III trial; the initiation of patient recruitment in the phase II trial; and advancing the subcutaneous formulation of CardiolRx™ as a potential anti-fibrotic and anti-inflammatory therapy. The forward-looking information contained herein reflects Cardiol’s current expectations or beliefs based on information currently available to it, including Cardiol’s ability to initiate and successfully complete patient enrollment in trials and to make advancing the subcutaneous formulation of CardiolRx™. This forward-looking information 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 actual events or results to differ materially from future results, performance or achievements. expressed or implied by forward-looking information and are not (and should not be taken as) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties discussed in the Company’s Annual Information Form dated March 23, 2022, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties and other factors should be carefully considered, and investors should not place undue reliance on forward-looking information. Any forward-looking information speaks only as of the date it is made and, except as required by applicable securities laws, Cardiol disclaims any intention or obligation to update or revise such forward-looking information, whether whether as a result of news of information, future events or results, or otherwise.

For more information, please contact:

Trevor Burns, Investor Relations +1-289-910-0855
[email protected]

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/124293


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