Overview
Cardiol Therapeutics (NASDAQ:CRDL,TSX:CRDL) is a clinical-stage life sciences firm centered on creating anti-inflammatory and anti-fibrotic therapies for the remedy of coronary heart illness. The Firm’s lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral answer, is pharmaceutically manufactured and in scientific improvement to be used within the remedy of coronary heart illness. It’s acknowledged that cannabidiol modulates activation of the inflammasome pathway, an intracellular course of recognized to play an vital function within the improvement and development of irritation and fibrosis related to myocarditis, pericarditis, and coronary heart failure.
Cardiol has acquired Investigational New Drug Utility authorization from the USA Meals and Drug Administration (US FDA) to conduct scientific research to judge the efficacy and security of CardiolRx™ in two ailments affecting the guts: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory illness of the pericardium which is related to signs together with debilitating chest ache, shortness of breath, and fatigue, and leads to bodily limitations, lowered high quality of life, emergency division visits, and hospitalizations, includes the finished Section II MAvERIC-Pilot research (NCT05494788) and the continuing Section III MAVERIC trial (NCT06708299). The continuing ARCHER trial (NCT05180240) is a Section II research in acute myocarditis, an vital explanation for acute and fulminant coronary heart failure in younger adults and a number one explanation for sudden cardiac loss of life in individuals lower than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the remedy of pericarditis, which incorporates recurrent pericarditis.
Cardiol can be creating CRD-38, a novel subcutaneously administered drug formulation supposed to be used in coronary heart failure – a number one explanation for loss of life and hospitalization within the developed world, with related healthcare prices in the USA exceeding $30 billion yearly.
Firm Highlights
Late-stage Pipeline: Lead oral drug candidate, CardiolRx™, in Section III MAVERIC trial for recurrent pericarditis (RP).Preliminary Market Alternative: Present income for third line RP remedy within the US is roughly $500M and forecast to develop to $1B by 2028.**Primarily based on present income steering for IL-1 blocker within the U.S; analysts’ forecast >$1Bn by 2028.Validated Goal: Focusing on inflammasome activation – central to the event and development of a number of cardiac ailments.World-class Collaborations: Established long-standing working relationships with main researchers and clinicians at famend worldwide facilities of excellence.Close to-term Worth Drivers: Begin affected person enrollment in MAVERIC trial; report top-line outcomes from ARCHER Section II trial; advance CRD-38 for coronary heart failure into scientific improvement.
Key Tasks
MAVERIC Program for Recurrent Pericarditis
The MAVERIC Program in recurrent pericarditis includes the finished Section II MAvERIC-Pilot research and the continuing Section III MAVERIC trial. Pericarditis is an inflammatory illness of the pericardium (the membrane or sac that surrounds the guts) that’s related to signs that embody debilitating chest ache, shortness of breath and fatigue, and leads to bodily limitations, lowered high quality of life, emergency division visits, and hospitalizations.
Pericarditis incessantly outcomes from a viral an infection. Following an preliminary episode, sufferers could have a number of recurrences, and the first purpose of remedy is recurrence prevention. Vital accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the guts. The one FDA-approved remedy for recurrent pericarditis, launched in 2021, is expensive and is primarily used as a third-line intervention. On an annual foundation, the variety of sufferers in the USA having skilled at the very least one recurrence is estimated at 38,000. Roughly 60 p.c of sufferers with a number of recurrences (>1) nonetheless undergo for longer than two years, and one third are nonetheless impacted at 5 years. Hospitalization because of recurrent pericarditis is usually related to a 6-8-day size of keep and price per keep is estimated to vary between $20,000 and $30,000 in the USA. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the remedy of pericarditis, which incorporates recurrent pericarditis.
In November 2024, Cardiol reported scientific outcomes from its Section II open-label MAvERIC-Pilot research investigating the affect of CardiolRx™ administered to sufferers with symptomatic recurrent pericarditis. The information confirmed that the marked, speedy and clinically significant enhancements in each pericarditis ache and irritation reported on the 8-week main endpoint, have been maintained all through the extension interval of the 26-week research. As well as, sufferers’ episodes of pericarditis per 12 months have been considerably lowered whereas on CardiolRx™ as in comparison with episodes per 12 months previous to the research. The information have been included in an oral presentation as a part of the Laennec Clinician-Educator Award & Lecture on the American Coronary heart Affiliation Scientific Classes 2024. Dr. S. Allen Luis, Co-Director of the Pericardial Ailments Clinic and Affiliate Professor of Medication within the Division of Cardiovascular Medication on the Mayo Clinic, introduced on behalf of the MAvERIC-Pilot investigators. These findings help the initiation of the MAVERIC Section III trial, designed to evaluate CardiolRx™ for the remedy of pericarditis sufferers to forestall recurrence.
Cardiol is advancing their lead oral drug candidate, CardiolRx™, into the MAVERIC Section III trial to display the affect of CardiolRx™ on pericarditis recurrence in a high-risk affected person inhabitants. The MAVERIC Section III trial is anticipated to enroll 110 sufferers at roughly 20 scientific facilities in the USA and Europe specializing in pericarditis care. The protocol has been designed in collaboration with thought leaders in pericardial illness. The research chairman is Dr. Allan L. Klein, director of the Heart of Pericardial Ailments and professor of drugs, on the Coronary heart and Vascular Institute on the Cleveland Clinic. The first efficacy endpoint is the variety of sufferers (proportion) free from a brand new episode of recurrent pericarditis at 24 weeks change. Different endpoints embody time to new recurrence episode, change in NRS ache rating – a validated scientific software used throughout a number of situations together with earlier research of recurrent pericarditis – and alter in C-reactive protein, a marker of irritation.
Six extremely distinguished thought leaders in cardiology of from the Cleveland Clinic, the Mayo Clinic, the College of Udine, the Monash Victoria Coronary heart Institute, the College of Virginia, and Northwestern College comprise a committee of unbiased advisors established to design, oversee, and information Cardiol’s MAVERIC Section III trial.
“Recurrent pericarditis is a debilitating inflammatory coronary heart illness related to signs that adversely have an effect on high quality of life and bodily exercise. Outcomes of the MAvERIC-Pilot research will help in additional understanding the therapeutic profile of our lead investigational drug on this situation and inform the design of a pivotal Section III scientific trial to underpin the potential regulatory approval of CardiolRx, which can be being evaluated within the world ARCHER Section II trial in sufferers presenting with acute myocarditis,” mentioned David Elsley, Cardiol Therapeutics’ President and Chief Govt Officer.
ARCHER Trial for Acute Myocarditis
Cardiol’s ongoing ARCHER trial is a Section II research in acute myocarditis, an vital explanation for acute and fulminant coronary heart failure in younger adults and a number one explanation for sudden cardiac loss of life in individuals lower than 35 years of age. Myocarditis is an acute inflammatory situation of the guts muscle (myocardium) characterised by chest ache, impaired cardiac operate, atrial and ventricular arrhythmias, and conduction disturbances. Though viral an infection is the most typical explanation for myocarditis, the situation can even consequence from bacterial an infection, generally used medication and mRNA vaccines, in addition to therapies used to deal with a number of widespread cancers, together with chemo-therapeutic brokers and immune checkpoint inhibitors.
There are not any FDA-approved therapies for acute myocarditis. Sufferers hospitalized with the situation expertise a median 7-day size of keep and a 4 – 6 p.c danger of in-hospital mortality, with common hospital cost per keep estimated at $110,000 in the USA.
ARCHER is a Section II, multi-center, worldwide, double-blind, randomized, placebo-controlled trial is designed to check the affect of CardiolRx™ on myocardial restoration in sufferers with acute myocarditis. The first efficacy endpoints of the ARCHER trial include extracellular quantity (ECV) and world longitudinal pressure (GLS). The secondary efficacy endpoint is left ventricular ejection fraction. Since individuals with acute myocarditis have impaired coronary heart operate, present remedy relies on standard-of-care suggestions for coronary heart failure. This consists of diuretics, ACE inhibitors, angiotensin receptors blockers, beta-blockers, and aldosterone inhibitors. For these with a extreme and sudden onset presentation, intensive care is usually required, with using inotropic drugs (to extend the power of the guts muscle contraction) and infrequently, heart-lung bypass or ventricular help gadgets. There’s in any other case no particular remedy for acute myocarditis though some sufferers have responded to immuno-suppressive remedy together with steroids, however the knowledge aren’t conclusive sufficient for this to be the really helpful remedy.
An unbiased scientific steering committee, comprising 10 extremely distinguished thought leaders in cardiology from the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Coronary heart and Vascular Heart, the College of Ottawa Coronary heart Institute, McGill College Well being Centre, the College of Pittsburgh Medical Heart, College Medication Berlin, Tel Aviv “Sourasky” Medical Heart, São Paulo College Medical College, and Pitié Salpêtrière Hospital (Sorbonne College), has been established to design, oversee, and information the ARCHER trial.
Cardiol Therapeutics’ Coronary heart Failure Program
Coronary heart failure impacts greater than 64 million individuals globally and related healthcare prices exceed $30 billion yearly within the US alone. Coronary heart failure is a persistent, progressive syndrome during which the guts muscle is unable to pump sufficient blood to fulfill the physique’s wants for blood and oxygen. Folks with coronary heart failure undergo from shortness of breath, speedy coronary heart fee, edema, lowered train capability, typically battle with easy every day actions and are incessantly hospitalized. For a lot of, these signs considerably scale back their high quality of life. Recognized causes of coronary heart failure embody ischemic coronary heart illness and myocardial infarction (coronary heart assault), hypertension, valvular coronary heart illness, inflammatory ailments of the guts comparable to myocarditis and cardiomyopathies, anti-cancer therapies, and inherited metabolic ailments.
Coronary heart failure stays a number one explanation for morbidity and mortality worldwide and persists as a rising well being and financial burden. In the USA alone, 6 million individuals over the age of 20 live with coronary heart failure, and this quantity is projected to extend to greater than 8 million by 2030. The entire annual value attributed to coronary heart failure is projected to extend to $69.8 billion by 2030.
Complete deaths attributed to coronary heart failure yearly in the USA have been reported within the vary of 86,000 to greater than 300,000, and hospitalizations vary from 800,000 to 1.3 million. The five-year mortality fee for these with coronary heart failure has been reported at 52.6 p.c total.
Cardiol is creating CRD-38, a novel subcutaneously administered drug formulation supposed to be used in coronary heart failure. The Firm are endeavor IND-enabling actions to help scientific analysis of CRD-38 as a therapeutic technique in coronary heart failure care – a number one explanation for loss of life and hospitalization within the developed world, with related healthcare prices in the USA exceeding $30 billion yearly.
In 2025, Cardiol introduced the publication of analysis within the Journal of the American School of Cardiology: Fundamental to Translational Science (“JACBTS”), titled “Cannabidiol Prevents Coronary heart Failure Dysfunction and Transforming By way of Preservation of Mitochondrial Perform and Calcium Dealing with”. This analysis was carried out by scientists from Tecnológico de Monterrey who, along with researchers from the DeBakey Coronary heart and Vascular Heart in Houston, TX, are collaborating with Cardiol on the event of the Firm’s proprietary subcutaneous formulation of cannabidiol, CRD-38, to deal with coronary heart failure with preserved ejection fraction. This widespread type of coronary heart failure stays a number one explanation for hospitalization worldwide and is related to a five-year mortality that exceeds 75% in hospitalized sufferers.
Dr. Andrew Hamer, Cardiol Therapeutics’ Chief Medical Officer and Head of Analysis & Growth acknowledged: “Coronary heart failure development is characterised by fibrosis, irritation, and decreased contractile operate of the myocardium, partially pushed by mitochondrial dysfunction. The JACBTS publication gives fascinating new knowledge that counsel a key mode of motion of CRD-38 to doubtlessly deal with coronary heart failure is thru its means to maintain cardiomyocytes, the muscle cells of the guts, and protect mitochondrial operate, the vitality producing constructions in cardiac cells. We sit up for incorporating this new info into our CRD-38 improvement program as we full the IND-enabling work essential to help advancing this novel drug candidate into scientific improvement.”
These newly printed knowledge display that pharmaceutically manufactured cannabidiol, administered subcutaneously, gives cardioprotection in a pre-clinical mannequin of coronary heart failure by enhancing cardiac operate and lowering cardiac hypertrophy, reworking, irritation, and cell loss of life, and gives extra vital rationale for the event of CRD-38 as a brand new method to the remedy of coronary heart failure.
Administration Group
David Elsley – President, Chief Govt Officer, and Director
David Elsley is the founder and CEO of Vasogen and has an MBA diploma. Elsley has over 30 years of expertise creating, financing, and managing all points of company improvement in biotechnology and high-growth organizations. Elsley based Vasogen, a biotechnology firm centered on the analysis and business improvement of novel therapeutics for the remedy of coronary heart failure and different inflammatory situations. Elsley assembled a staff of administration, administrators and scientific advisors comprising trade professionals and thought leaders from North America and Europe.
Dr. Andrew Hamer – Chief Medical Officer and Head of Analysis and Growth
Dr. Andrew Hamer has an MBChB diploma. Hamer is the previous govt director at Amgen, accountable for main world improvement of Repatha®. Hamer is the previous chief heart specialist at Nelson Hospital, New Zealand. He has over 19 years of expertise working towards cardiology and inside drugs.
Chris Waddick – Chief Monetary Officer and Director
Chris Waddick has an MBA diploma, is a chartered skilled accountant, and is an authorized administration accountant. Waddick has over 30 years of expertise in monetary and govt roles within the biotechnology and vitality industries. Waddick is the previous chief monetary officer and chief working officer of Vasogen Inc.
Bernard Lim – Chief Working Officer
Bernard Lim has over 30 years of expertise within the life sciences trade, spanning biotechnology, diagnostics, medical gadgets, and high-technology firms. Lim is the founder and CEO of a extremely profitable drug supply firm that he led from analysis and improvement by to commercialization, and facilitated its eventual acquisition by Eli Lily. Lim is a chartered engineer per UK requirements and is a member of the Establishment of Engineering and Expertise.
Andrea B. Parker – Senior Director of Scientific Operations
Dr. Andrea Parker is the previous chief scientific officer at Peter Munk Cardiac Heart, College Well being Community. Parker is a scientific epidemiologist with greater than 30 years’ expertise in scientific trials design, administration, and execution in trade and tutorial settings.
John A. Geddes – Vice-President, Company Growth
John Geddes has over 25 years of expertise within the healthcare trade, comprising roles inside pharmaceutical, biotechnology, scientific diagnostics, and life science analysis expertise firms. Geddes has an MBA diploma and is the previous company senior director of enterprise improvement at Luminex Company, a DiaSorin Firm.
Anne Tomalin – Director of Regulatory and High quality
Anne Tomalin is the founding father of CanReg and TPIreg, regulatory corporations beforehand offered to Optum Perception and Innomar Methods, respectively. Tomalin is an knowledgeable in regulatory affairs in Canada, the USA, and Europe.
Board of Administrators
Guillermo Torre-Amione – Chairman
Guillermo Torre-Amione is the president of TecSalud tutorial medical middle and college of the Instituto Tecnológico y de Estudios Superiores de Monterrey (ITESM), Mexico. Torre-Amione is the previous director of Cardiac Transplantation on the Houston Methodist DeBakey Coronary heart & Vascular Heart.
Jennifer M. Chao – Director
Jennifer M. Chao has over 25 years of expertise within the biotech and life sciences industries centered totally on finance and company technique. Chao is managing associate of CoreStrategies Administration, an organization she based in 2008 to offer transformational company and monetary methods to biotech/life science firms for maximizing core valuation.
Peter Pekos – Director
Founding father of Dalton Pharma, Peter Pekos has broad expertise in analysis, improvement, and commercialization of prescribed drugs, merchandise, and companies.
Colin Stott – Director
Colin Stott has over 30 years of expertise in pre-clinical and scientific improvement, with particular experience within the improvement of cannabinoid-based medicines. Stott is the chief working officer of Alterola Biotech Inc. and the previous scientific affairs director, worldwide, and analysis and improvement operations director for GW Prescribed drugs, a world chief within the improvement of cannabinoid therapeutics.
Teri Loxam – Director
Teri Loxam has over 25 years of expertise within the pharmaceutical, life sciences and TMT industries with numerous roles spanning technique, investor relations, finance and communications. Loxam is chief monetary officer of Compass Pathways plc (Nasdaq: CMPS), a biotechnology firm devoted to accelerating affected person entry to evidence-based innovation in psychological well being.
Michael Willner – Director
Michael Willner has practiced as an lawyer and an authorized public accountant. He graduated from Emory College Regulation College as a member of the Emory Regulation Assessment. Subsequently, Willner practiced actual property and company regulation with New York Metropolis-based Milbank, Tweed, Hadley & McCloy, one of many nation’s most distinguished worldwide regulation corporations. Earlier than his authorized profession, Willner was employed by the previous Arthur Andersen & Firm, a nationwide accounting agency, the place he practiced within the tax division.
Scientific Advisory Board
Dr. Paul Ridker
Dr. Paul Ridker is director of the Heart for Cardiovascular Illness Prevention, a translational analysis unit at Brigham and Girls’s Hospital in Boston (BWH). A cardiovascular drugs specialist, he’s additionally the Eugene Braunwald Professor of Medication at Harvard College of Medication (HSM). Ridker acquired his medical diploma from HSM after which accomplished an inside drugs residency and a cardiology fellowship at BWH. He’s board licensed in inside drugs. Ridker’s scientific pursuits embody coronary artery illness and the underlying causes and prevention of atherosclerotic illness. He’s the writer of over 900 peer-reviewed publications and opinions, 64 ebook chapters, and 6 textbooks associated to cardiovascular drugs.
Dr. Bruce McManus
Dr. Bruce McManus is a professor emeritus of the Division of Pathology and Laboratory Medication on the College of British Columbia. He has served as CEO of the Heart of Excellence for Prevention of Organ Failure (PROOF Heart), director of the UBC Heart for Coronary heart and Lung Innovation, and scientific director of the Institute of Circulatory and Respiratory Well being, CIHR. McManus acquired BA and MD levels from the College of Saskatchewan, an MSc from Pennsylvania State College, and a PhD from the College of Toledo. McManus pursued post-doctoral fellowships on the College of California, Santa Barbara in environmental physiology and on the Nationwide Coronary heart, Lung, and Blood Institute in Bethesda. McManus served as MD in cardiovascular and pulmonary pathology, and accomplished residency coaching on the Peter Bent Brigham Hospital, Harvard College, in Inside Medication and Pathology.
Dr. Joseph Hill
Dr. Joseph Hill is a professor of inside drugs and molecular biology, chief of cardiology at UT Southwestern Medical Heart, in Dallas, and is the director of the Harry S. Moss Coronary heart Heart. Hill holds each the James T. Willerson, MD, distinguished chair in cardiovascular ailments, and the Frank M. Ryburn Jr. Chair in Coronary heart Analysis. He graduated from Duke College with an MD and a PhD in 1987. Hill’s PhD dissertation analysis was within the subject of cardiac ion channel biophysics. He then labored for 5 years as a postdoctoral fellow on the Institut Pasteur in Paris, finding out central and peripheral nicotinic receptors. He subsequent accomplished an inside drugs internship and residency, in addition to a scientific cardiology fellowship, on the Brigham and Girls’s Hospital, Harvard Medical College.
