Dr. Andrew Hamer reports
CARDIOL THERAPEUTICS ANNOUNCES ALL COLLABORATING CLINICAL RESEARCH CENTERS NOW INITIATED AND ELIGIBLE TO ENROLL PATIENTS IN Archer, A PHASE II TRIAL OF CARDIOLRX(TM) FOR THE TREATMENT OF ACUTE MYOCARDITIS
Cardiol Therapeutics Inc. has noted that all collaborating research centres have been initiated and are eligible to enroll patients in Archer, the company's phase 2, multicentre, international, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. Archer is expected to enroll 100 patients at major cardiac centres in North America, Europe, Latin America and Israel.
"Initiation of all clinical research centres, coupled with the current rate of randomizations, as well as an expected increase in acute myocarditis cases as the northern hemisphere enters the viral infection seasons of autumn and winter, provide us a high degree of confidence to forecast that Archer will complete full patient enrolment ahead of schedule," commented Dr. Andrew Hamer, Cardiol Therapeutics' chief medical officer, and head of research and development. "This is a significant milestone in expanding the reach of Archer worldwide and contributing to evaluating the clinical potential of CardiolRx in acute myocarditis, an inflammatory condition of the heart muscle characterized by chest pain, impaired heart function, arrhythmias and conduction disturbances. The data generated from patients who enroll in Archer will provide important information in support of the use of CardiolRx as a novel small molecule therapeutic approach for this debilitating rare disease, which is an important cause of acute and fulminant heart failure, and a leading cause of sudden cardiac death in people under 35 years of age, for which there are no approved therapies."
The Archer trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centres of excellence. The trial is now enrolling patients at over 35 pre-eminent cardiovascular research centres in North America, France, Brazil and Israel. The co-primary outcome measures of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extracellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis.
The company 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 have been created to provide the sponsors of a drug significant incentives, including periods of prolonged marketing exclusivity and exemptions from certain fees, to develop treatments for rare diseases. Products with orphan drug designation also frequently qualify for accelerated regulatory review.
About Cardiol Therapeutics Inc.
Cardiol Therapeutics 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 U.S. 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 2 multicentre 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 2 multinational, 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 health care costs in the United States exceeding $30-billion annually.
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