Biotech stock Cardiol Therapeutics Inc. (TSX:CRDL | OTCQX:CRTPF | FSE: CT9) is setting the stage for an exciting 2021, as its mission to treat cardiovascular disease picks up pace. In a press release dated April 12, Cardiol Therapeutics announced the topline results of its latest Phase I clinical trial. And these are very positive indeed.
Developing cannabidiol based CardiolRx™
The clinical trial involved testing its proprietary treatment, CardiolRx™, on a randomized selection of 52 subjects aged between 25 and 60 years old.
CardiolRx™ is a pharmaceutically produced oral cannabidiol formulation that is THC-free (<10 ppm). It is being developed by Cardiol Therapeutics specifically to treat acute and chronic inflammation associated with heart disease.
But CardiolRx™ is not the only cannabidiol medication developed by Cardiol Therapeutics. The Company recently commercialized Cortalex to the Canadian medicinal cannabidiol market.
How did the Phase I study work?
The Phase I single and multiple ascending dose trial took place over six days. Furthermore, it’s among the most comprehensive Phase I clinical trials ever conducted using a pharmaceutically produced cannabidiol formulation on adults.
To meet stringent requirements, patients were split into two groups containing a mix of active and placebo participants. It was a double-bind study testing the drug’s safety, tolerability, and pharmacokinetic profile of CardiolRx™ at various doses.
They took regular blood samples from the subjects to measure levels of cannabidiol and its two main metabolites.
These topline results show CardiolRx™ to be safe and generally well tolerated at all dose levels. And with no serious adverse events reported in the study, it’s a very reassuring step in ensuring ongoing progress to commercializing the drug.
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Why the success of this Phase I trial matters
From here, Cardiol Therapeutics wants to progress to a Phase II international trial in acute myocarditis, an inflammatory condition of the heart. This remains a leading cause of sudden cardiac death in children and young people under 35 years old.
To get to this stage, it must win the FDA’s stamp of approval, and the results of this Phase I study should help. Thus, it intends to file an IND application with the FDA to this end.
US Covid-19 cardiovascular study
In addition to the Phase I study conducted to test dosing, the Company is set to get underway with a Phase II/III clinical trial in the US. This is investigating the cardioprotective properties of CardiolRx™ in 422 hospitalized patients suffering from Covid-19 that also have a history of, or risk factors for, cardiovascular disease.
The reason this separate trial can start is due to the urgent nature of dealing with Covid-19 and its detrimental effect on patients’ wellbeing.
To meet FDA approval, any new drug must undergo stringent testing through certified clinical trials. Consequently, the results of the Phase I study show its findings to be consistent with published results for oral cannabidiol formulations. Thus, it will serve as a guideline for the dosing regimen adopted by the ongoing US Phase II/III trial in Covid-19 patients.
On a mission to beat cardiovascular disease
Cardiol Therapeutics is developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease. These are life-threatening conditions that kill millions every year. Therefore, breakthrough treatments are increasingly sought after and in high demand.
Accordingly, Cardiol is also developing a subcutaneous formulation of CardiolRx™ and other anti-inflammatory therapies to treat chronic heart failure. It’s a leading cause of death and hospitalization in North America. In fact, the associated annual healthcare costs are believed to exceed $30 billion in the US alone.
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