Results anticipated to assist the Company’s plans to file an IND utility with the FDA for a Phase II worldwide trial in acute myocarditis
Oakville, Ontario–(Newsfile Corp. – April 12, 2021) – Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) (FSE: CT9) (“Cardiol” or the “Company”), a clinical-stage biotechnology firm centered on creating progressive anti-inflammatory therapies for the remedy of heart problems (CVD), at the moment introduced topline outcomes from a Phase I single and a number of ascending dose medical trial of CardiolRx
, a pharmaceutically produced oral cannabidiol formulation being developed for the remedy of acute and continual irritation related to coronary heart illness.
“As our study represents one of the most comprehensive Phase I clinical trials ever conducted in adults with a pharmaceutically produced cannabidiol formulation, we are pleased that the data are consistent with our expectations concerning the drug’s safety, tolerability, and PK profile,” mentioned David Elsley, President and CEO of Cardiol Therapeutics. “Study results support the dosing regimen being utilized in our U.S. Phase II/III clinical trial investigating the cardioprotective properties of CardiolRx in 422 hospitalized patients with COVID-19 with a prior history of, or risk factors for, cardiovascular disease, and our plans to file a IND application with the FDA for a Phase II international trial in acute myocarditis, an inflammatory condition of the heart, which remains a leading cause of sudden cardiac death in children and young adults.”
The Phase I trial was a randomized, placebo-controlled, double-blind research designed to guage the protection, tolerability, and pharmacokinetic (PK) profile of CardiolRx at numerous dose ranges. The research randomized 52 topics (age vary 25 to 60 years) to at least one of two teams. In Group A, there have been three sub-groups, every involving 12 topics (9 energetic and three placebo), with every topic receiving a single dose of 5 mg/kg or 15 mg/kg of CardiolRx, in both the fed or fasted state. In Group B, there have been two sub-groups, every involving eight topics (six energetic and two placebo) with every topic receiving 5 mg/kg or 15 mg/kg twice every day for six days. Serial blood samples had been taken to measure the extent of cannabidiol and its two primary metabolites.
Topline outcomes demonstrated that CardiolRx was secure and usually properly tolerated in any respect dose ranges, with no critical antagonistic occasions reported within the research. Fifty-one of the 52 enrolled topics accomplished all necessities of the protocol. Each topic had repeated customary measures of security together with bodily examination (with very important indicators), electrocardiogram (ECG) to watch cardiac time intervals (significantly, the QTc interval, which is a vital measure of the chance for irregular coronary heart rhythms), in addition to a quantity of biochemical and coagulation laboratory checks. Despite the comparatively excessive doses of CardiolRx administered through the research, there have been no ECG or irregular laboratory findings after six days of dosing; particularly, no elevation of liver enzymes or QTc adjustments had been detected. The recorded antagonistic occasions had been all delicate or reasonable in severity and had been primarily associated to the gastro-intestinal tract.
PK research decided that blood ranges of the drug usually elevated with growing dose. Following a single dose of CardiolRx, the realm below the time-concentration curve (AUC), which represents the extent of publicity to the drug, was 6-7-fold larger within the fed state than the fasted state. Furthermore, following single doses of CardiolRx within the fed state, the time to maximal blood stage (Tmax) was within the vary of 5 to seven hours, with a half-life of 26 to 29 hours. The above findings are in step with printed outcomes for oral cannabidiol formulations and function a rationale for the dosing routine that will probably be utilized within the Company’s Phase II/III research being initiated within the U.S. in COVID-19 sufferers who’re hospitalized with a previous historical past of, or threat elements for CVD, and for the deliberate Phase II program in acute myocarditis.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) (FSE: CT9) is a clinical-stage biotechnology firm centered on the analysis and medical improvement of progressive anti-inflammatory therapies for the remedy of heart problems (“CVD”). The Company’s lead product, CardiolRx
, is a pharmaceutically produced oral cannabidiol formulation that’s presently getting into a Phase II/III outcomes research in hospitalized sufferers testing constructive for the COVID-19 virus. This probably registrational trial is designed to guage the efficacy and security of CardiolRx as a cardioprotective remedy to scale back mortality and main cardiovascular occasions in COVID-19 sufferers who’ve a previous historical past of, or threat elements for, CVD, and to research the affect CardiolRx has on key markers of inflammatory coronary heart illness.
Cardiol can also be planning to file an investigational new drug (“IND”) utility for a Phase II worldwide trial that may examine the anti-inflammatory and anti-fibrotic properties of CardiolRx in sufferers with acute myocarditis, which stays the most typical trigger of sudden cardiac demise in folks below 35 years of age. In addition, Cardiol is creating a subcutaneous formulation of CardiolRx and different anti-inflammatory therapies for the remedy of continual coronary heart failure – a number one trigger of demise and hospitalization in North America, with related annual healthcare prices within the U.S. alone exceeding $30 billion.
Cardiol lately commercialized Cortalex
(cortalex.com), a pharmaceutically produced cannabidiol formulation developed to handle underserved segments of the Canadian medicinal cannabidiol market.
For extra details about Cardiol Therapeutics, please go to cardiolrx.com.
Cautionary assertion concerning forward-looking data:
This information launch accommodates “forward-looking information” throughout the that means of relevant Canadian securities legal guidelines. All statements, aside from statements of historic truth, that deal with actions, occasions, or developments that Cardiol Therapeutics Inc. (“Cardiol” or the “Company”) believes, expects, or anticipates will, might, may or may happen sooner or later are “forward-looking information.” Forward-looking data contained herein might embody, statements referring to the Company’s plans for medical trials and its improvement of progressive anti-inflammatory therapies for the remedy of heart problems. Forward-looking data contained herein displays the present expectations or beliefs of Cardiol based mostly on data presently out there to it and is topic to a range of identified and unknown dangers and uncertainties and different elements that would trigger the precise occasions or outcomes to vary materially from any future outcomes, efficiency or achievements expressed or implied by the forward-looking data, and aren’t (and shouldn’t be thought-about to be) ensures of future efficiency. These dangers and uncertainties and different elements embody the dangers and uncertainties referred to within the Company’s Annual Information Form dated March 31, 2021, together with the dangers and uncertainties related to product commercialization and medical research. These dangers, uncertainties and different elements ought to be thought-about fastidiously, and buyers shouldn’t place undue reliance on the forward-looking data. Any forward-looking data speaks solely as of the date on which it’s made and, besides as could also be required by relevant securities legal guidelines, Cardiol disclaims any intent or obligation to replace or revise such forward-looking data, whether or not because of this of new data, future occasions or outcomes or in any other case.
For additional data, please contact:
David Elsley, President & CEO
Trevor Burns, Investor Relations