Overview
Cardiol Therapeutics (NASDAQ:CRDL,TSX:CRDL) is a clinical-stage life sciences firm centered on growing anti-inflammatory and anti-fibrotic therapies for the remedy of coronary heart illness. The Firm’s lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral resolution, is pharmaceutically manufactured and in medical 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 identified to play an vital position within the improvement and development of irritation and fibrosis related to myocarditis, pericarditis, and coronary heart failure.
Cardiol has obtained Investigational New Drug Software authorization from the USA Meals and Drug Administration (US FDA) to conduct medical research to guage the efficacy and security of CardiolRx™ in two illnesses affecting the center: 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 ends in bodily limitations, diminished high quality of life, emergency division visits, and hospitalizations, contains the finished Part II MAvERIC-Pilot research (NCT05494788) and the continued Part III MAVERIC trial (NCT06708299). The continued ARCHER trial (NCT05180240) is a Part II research in acute myocarditis, an vital reason behind acute and fulminant coronary heart failure in younger adults and a number one reason behind sudden cardiac dying in folks 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 also be growing CRD-38, a novel subcutaneously administered drug formulation meant to be used in coronary heart failure – a number one reason behind dying 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 Part 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 illnesses.
- 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 Part II trial; advance CRD-38 for coronary heart failure into medical improvement.
Key Tasks
MAVERIC Program for Recurrent Pericarditis
The MAVERIC Program in recurrent pericarditis contains the finished Part II MAvERIC-Pilot research and the continued Part III MAVERIC trial. Pericarditis is an inflammatory illness of the pericardium (the membrane or sac that surrounds the center) that’s related to signs that embody debilitating chest ache, shortness of breath and fatigue, and ends in bodily limitations, diminished high quality of life, emergency division visits, and hospitalizations.
Pericarditis regularly 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. Important accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the center. 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 endure for longer than two years, and one third are nonetheless impacted at 5 years. Hospitalization as a result 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 medical outcomes from its Part II open-label MAvERIC-Pilot research investigating the influence 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 yr have been considerably diminished whereas on CardiolRx™ as in comparison with episodes per yr 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 Illnesses 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 Part III trial, designed to evaluate CardiolRx™ for the remedy of pericarditis sufferers to stop recurrence.
Cardiol is advancing their lead oral drug candidate, CardiolRx™, into the MAVERIC Part III trial to show the influence of CardiolRx™ on pericarditis recurrence in a high-risk affected person inhabitants. The MAVERIC Part III trial is anticipated to enroll 110 sufferers at roughly 20 medical facilities in the USA and Europe focusing on 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 Illnesses and professor of drugs, on the Coronary heart and Vascular Institute on the Cleveland Clinic. The first efficacy endpoint is the variety of sufferers (share) 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 medical instrument used throughout a number of circumstances 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 Part 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 Part III medical trial to underpin the potential regulatory approval of CardiolRx, which can also be being evaluated within the world ARCHER Part 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 Part II research in acute myocarditis, an vital reason behind acute and fulminant coronary heart failure in younger adults and a number one reason behind sudden cardiac dying in folks lower than 35 years of age. Myocarditis is an acute inflammatory situation of the center muscle (myocardium) characterised by chest ache, impaired cardiac perform, atrial and ventricular arrhythmias, and conduction disturbances. Though viral an infection is the commonest reason behind myocarditis, the situation may also outcome 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 aren’t any FDA-approved therapies for acute myocarditis. Sufferers hospitalized with the situation expertise a mean 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 Part II, multi-center, worldwide, double-blind, randomized, placebo-controlled trial is designed to check the influence of CardiolRx™ on myocardial restoration in sufferers with acute myocarditis. The first efficacy endpoints of the ARCHER trial encompass extracellular quantity (ECV) and world longitudinal pressure (GLS). The secondary efficacy endpoint is left ventricular ejection fraction. Since folks with acute myocarditis have impaired coronary heart perform, present remedy is predicated on standard-of-care suggestions for coronary heart failure. This contains 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 the usage of inotropic medicines (to extend the drive of the center 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 should not conclusive sufficient for this to be the really useful remedy.
An unbiased medical 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 Faculty, 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 folks globally and related healthcare prices exceed $30 billion yearly within the US alone. Coronary heart failure is a persistent, progressive syndrome wherein the center muscle is unable to pump sufficient blood to satisfy the physique’s wants for blood and oxygen. Individuals with coronary heart failure endure from shortness of breath, speedy coronary heart fee, edema, diminished train capability, typically battle with easy day by day actions and are regularly hospitalized. For a lot of, these signs considerably cut 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 illnesses of the center akin to myocarditis and cardiomyopathies, anti-cancer therapies, and inherited metabolic illnesses.
Coronary heart failure stays a number one reason behind morbidity and mortality worldwide and persists as a rising well being and financial burden. In the USA alone, 6 million folks over the age of 20 reside with coronary heart failure, and this quantity is projected to extend to greater than 8 million by 2030. The whole 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 growing CRD-38, a novel subcutaneously administered drug formulation meant to be used in coronary heart failure. The Firm are endeavor IND-enabling actions to help medical analysis of CRD-38 as a therapeutic technique in coronary heart failure care – a number one reason behind dying 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: Primary to Translational Science (“JACBTS”), titled “Cannabidiol Prevents Heart Failure Dysfunction and Remodeling Through Preservation of Mitochondrial Function and Calcium Handling”. This analysis was performed 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 reason behind 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 perform of the myocardium, partly 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 capability to maintain cardiomyocytes, the muscle cells of the center, and protect mitochondrial perform, 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 medical improvement.”
These newly printed knowledge show that pharmaceutically manufactured cannabidiol, administered subcutaneously, gives cardioprotection in a pre-clinical mannequin of coronary heart failure by enhancing cardiac perform and decreasing cardiac hypertrophy, transforming, irritation, and cell dying, and gives extra vital rationale for the event of CRD-38 as a brand new strategy 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 growing, 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 industrial improvement of novel therapeutics for the remedy of coronary heart failure and different inflammatory circumstances. Elsley assembled a workforce 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 government director at Amgen, chargeable 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 practising cardiology and inside medication.
Chris Waddick – Chief Monetary Officer and Director
Chris Waddick has an MBA diploma, is a chartered skilled accountant, and is a licensed administration accountant. Waddick has over 30 years of expertise in monetary and government 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 means of 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 Know-how.
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 medical epidemiologist with greater than 30 years’ expertise in medical trials design, administration, and execution in trade and educational 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, medical diagnostics, and life science analysis know-how 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 companies beforehand bought to Optum Perception and Innomar Methods, respectively. Tomalin is an skilled in regulatory affairs in Canada, the USA, and Europe.
Board of Administrators
Guillermo Torre-Amione – Chairman
Guillermo Torre-Amione is the president of TecSalud educational medical middle and faculty 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 accomplice of CoreStrategies Administration, an organization she based in 2008 to supply 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 prescription drugs, merchandise, and providers.
Colin Stott – Director
Colin Stott has over 30 years of expertise in pre-clinical and medical 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 Prescription 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 various 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 a licensed public accountant. He graduated from Emory College Regulation Faculty as a member of the Emory Regulation Evaluate. Subsequently, Willner practiced actual property and company legislation with New York Metropolis-based Milbank, Tweed, Hadley & McCloy, one of many nation’s most outstanding worldwide legislation companies. 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 Ladies’s Hospital in Boston (BWH). A cardiovascular medication specialist, he’s additionally the Eugene Braunwald Professor of Medication at Harvard Faculty of Medication (HSM). Ridker obtained his medical diploma from HSM after which accomplished an inside medication residency and a cardiology fellowship at BWH. He’s board licensed in inside medication. Ridker’s medical pursuits embody coronary artery illness and the underlying causes and prevention of atherosclerotic illness. He’s the creator of over 900 peer-reviewed publications and opinions, 64 ebook chapters, and 6 textbooks associated to cardiovascular medication.
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 obtained 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 Inner Medication and Pathology.
Dr. Joseph Hill
Dr. Joseph Hill is a professor of inside medication 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 illnesses, 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 discipline 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 medication internship and residency, in addition to a medical cardiology fellowship, on the Brigham and Ladies’s Hospital, Harvard Medical Faculty.