A clinical-stage life sciences company focused on the research and and clinical development of cannabidiol as an anti-fibrotic and anti-inflammatory therapy for the cardiovascular disease
The Company’s lead product candidate, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being clinically developed for use in cardiovascular medicine. CardiolRx™ is currently being evaluated in a Phase II/III multi-national, 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 prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx™ has on key biomarkers associated with heart disease. Cardiol has also received IND authorization from the FDA to conduct a Phase II multi-national, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CardiolRx™ in acute myocarditis, which remains an important cause of acute and fulminant heart failure in young adults and is a leading cause of sudden cardiac death in people less than 35 years of age. In addition, Cardiol is developing a subcutaneous formulation of CardiolRx™ for the treatment of fibrosis and inflammation in the heart that is associated with the development and progression of heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the U.S. exceeding $30 billion annually
David Elsley, MBA
President & Chief Executive Officer
Andrew Hamer, MB, Chb
Chief Medical officer
Chris Waddick, MBA, CPA, CMA
Chief Financial Officer
Bernard Lim, MIET, CEng (UK)
Chief Operating Officer
Andrea B. Parker, MSc, PhD
Senior Director of Clinical Operations
Anne Tomalin, BA, BSc, RAC
Director of Regulatory and Quality
Blagoja Ristevski, BSc, CHE
Director of Chemical Engineering
and Manufacturing
• High-concentration oral cannabidiol formulation for acute inflammatory heart disease.
• In Phase II/III clinical development as a cardiorespiratory protective drug for patients with acute inflammatory heart disease.
• FDA clearance for its IND application for a Phase II international trial in acute myocarditis.
• Manufactured under cGMP to meet the highest standards for product purity, consistency, and stability
Final data: Expected in H2 2022
Trial design: 422 Patients with confirmed COVID-19 diagnosis
that have been admitted to a hospital and have
either pre-existing, or risk factors for, CVD.
• A positive outcome should allow it to serve as a pivotal trial for the basis of a registration study in support of an U.S. New Drug Application (NDA) filing.
• The COVID-19 pandemic is providing Cardiol with a unique opportunity to rapidly study the cardioprotective properties of CardiolRx.
• Cardiol is developing a subcutaneous formulation of CardiolRx for the treatment of inflammation in the heart that is associated with the development and progression of heart failure.
• Published third-party research has shown that cannabidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cannabidiol has lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cannabidiol has in heart failure patients, and to reduce myocardial fibrosis in a model of inflammatory heart disease.
Complete
patient enrollment
and report
top line results
in the Phase III/III
international
LANCER trial
examining the
cardioprotective
properties of
CardiolRx™
Initiate
patient enrollment
in a Phase II
international trial
of CardiolRx™ in
acute myocarditis
Advance
development of a
subcutaneous
formulation of
CardiolRx™ into an
IND enabling
program
Conduct further
discovery research
focused on
additional
anti-inflammatory
strategies
