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It’s no secret that Cardiol Therapeutics (Canada: CRDL, U.S.: CRTPF) is our favourite biotech company around, as we feel there is significant growth potential here. On Tuesday, December 15, 2020, Cardiol announced that they had appointed Worldwide Clinical Trials as the Contract Research Organization (CRO) for the company’s Phase 2/3 Outcomes Trial in High-risk Patients Hospitalized with COVID-19.
For those unlearned in the space, it may be hard to understand why this is so exciting, or what this release means for the future of the company. With that said, let’s look at each of these in turn.
What is a CRO? Why is Worldwide a Good Choice?
A Contract Research Organization is an outsourced medical research company that is hired to help manage clinical trials and perform other tasks to bring a drug to market. Just as a start-up may outsource their design work to avoid bringing on full-time staff members, hiring a CRO allows a biotech firm to stay nimble whilst getting the best professional care in its medical trials.
Worldwide is well-equipped to handle the trial as a proven research leader for both COVID-19 and cardiovascular disease (CVD); this kind of exposure is, of course, quite hard to find as it would require the organization to have historical experience with CVD whilst being agile enough to move into the virus treatment space this year.
Not only does Worldwide have experience in the initial research phase, they’re also proven throughout the entire development and bring-to-market process. Worldwide has experience “from early phase to late-stage clinical development, post-approval, and real-world evidence studies; delivering high quality clinical programs designed to support regulatory approvals in multiple jurisdictions.”
Worldwide employs more than 1,900 professionals and is operational in over 60 countries throughout North and South America, Europe, and Asia. They are proven as an international entity and can assist with the clinical research process, while Cardiol continues to focus on realizing business opportunities (such as Cortalex’s recent market appearance).
What Does this Mean for the Company, Moving Forward?
The central benefit from this trial is data.
Whilst this trial could indeed prove that Cardiol’s CBD product, CardiolRx™, has a positive impact in reducing mortality (aka death!) and other major cardiovascular outcomes in COVID-19 patients who have a prior history of, or risk factors for, cardiovascular disease, these findings are ancillary to the main business; they do not represent the central focus of Cardiol.
Don’t get us wrong, favourable results from the trial would represent another massive opportunity for CardiolRx, as a means to help reduce major cardiovascular concerns, and potentially even the mortality rate, resulting from COVID-19. This would be a huge accomplishment for Cardiol and benefit for the general population, representing an enormous breakthrough.
But again, the central benefit from this trial is data.
Cardiol’s mission is to develop novel solutions for inflammatory heart disease (including heart failure). The potential within the industry is massive and Cardiol can use this trial to investigate CardiolRx’s therapeutic influence on multiple key markers of inflammatory heart disease. By utilizing the data in this trial, Cardiol can become better equipped for treating specific conditions related to their mission and become globally recognized as a leader in the area. It’s somewhat serendipitous that CardiolRx has the potential to be beneficial for those afflicted with COVID that have a prior history of, or risk factors for CVD, as no one could have anticipated this virus when developing the drug.
When opportunity knocks, answer it with a plan to turn it into a lasting benefit.
Want to learn more about Cardiol Therapeutics?
Read our Company Analysis Here
Cardiol Therapeutics Appoints Worldwide Clinical Trials as CRO for the Company’s Phase II/III Outcomes Trial in High-risk Patients Hospitalized with COVID-19
Trial designed to investigate the cardioprotective properties of CardiolRx™ in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease now being initiated at clinical centers in the United States.
Oakville, ON – December 15, 2020 – Cardiol Therapeutics Inc. (TSX: CRDL)(OTCQX: CRTPF) (“Cardiol” or the “Company”), a clinical-stage biotechnology company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease (“CVD”), announces that it has appointed contract research organization (“CRO”) Worldwide Clinical Trials (“Worldwide”), as the Company initiates it’s Phase II/III trial in high-risk patients hospitalized with COVID-19 at clinical centers throughout the United States. The double-blind, placebo-controlled clinical trial is designed to investigate the efficacy and safety of CardiolRxTM, a pharmaceutically produced extra strength cannabidiol formulation, in 422 hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease. This patient population is at significant risk of developing cardiovascular complications, which are frequently fatal, during their illness.
Worldwide has been the CRO for several international COVID-19 clinical programs and has extensive experience in conducting clinical research focused on cardiovascular disease. With a global footprint, Worldwide provides unparalleled drug development expertise from early phase to late-stage clinical development, post-approval, and real-world evidence studies; delivering high quality clinical programs designed to support regulatory approvals in multiple jurisdictions. Employing more than 1,900 professionals, Worldwide provides drug development support services in over 60 countries with offices in North and South America, Europe, and Asia.
“We are pleased to be collaborating with Worldwide Clinical Trials as we initiate our Phase II/III trial in high-risk patients hospitalized with COVID-19 at clinical centers throughout the U.S.,” stated David Elsley, President and CEO of Cardiol Therapeutics. “While this potentially registrational trial is designed primarily to evaluate the impact of CardiolRx™ on reducing mortality and major cardiovascular outcomes in COVID-19 patients who have a prior history of, or risk factors for, cardiovascular disease, this important study will also investigate the therapy’s influence on key markers of inflammatory heart disease. These findings are expected to provide invaluable data with respect to the therapeutic potential of CardiolRx™ in the treatment of inflammatory heart disease, including heart failure which remains a leading cause of death and disability and a major economic burden in developed nations.”
The composite primary efficacy endpoint will be the difference between the active and placebo groups in the percentage of patients who develop, during the first 28 days following first dose of study medication, one or more of the following outcomes: i) all-cause mortality, ii) requirement for ICU admission and/or ventilatory support, and iii) cardiovascular complications, including the development of heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia. The study was designed by and will be overseen by an independent Steering Committee, consisting of international thought leaders in inflammatory heart disease. The Steering Committee is chaired by Dr. Dennis McNamara, Professor of Medicine and Director of the Center for Heart Failure Research, University of Pittsburgh and co-chaired by Dr. Leslie Cooper, Chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine and Chair of the Department of Cardiovascular Medicine, Mayo Clinic.
The rationale for using cannabidiol to treat patients with COVID-19 is based on its reported anti-inflammatory and cardioprotective effects which are anticipated to prevent COVID-19-related cardiovascular complications, thereby reducing morbidity and mortality. Cardiovascular complications such as myocardial injury (demonstrated by elevated blood troponin levels) are common in COVID-19 patients and are linked to a higher rate of mortality. Cannabidiol has been shown to reduce elevated troponin and reduce pro-inflammatory responses in models of cardiotoxicity. In pre-clinical models of cardiac injury, cannabidiol has been shown to be cardioprotective by reducing cardiac hypertrophy, fibrosis, and the production of certain re-modelling markers, such as cardiac B-type Natriuretic Peptide (BNP), which is elevated in patients with COVID-19, cardiac damage, and/or heart failure.
Disclaimer: Cardiol Therapeutics Inc. is a communications client of Edge Investments, and we own shares in the company.