Original-Research: Cardiol Therapeutics - von GBC AG

Einstufung von GBC AG zu Cardiol Therapeutics

Unternehmen: Cardiol Therapeutics

ISIN: CA14161Y2006

Anlass der Studie: Management Interview

Letzte Ratingänderung:

Analyst: Julien Desrosiers; Felix Haugg

The Company announced topline results from its Phase I Single and Multiple

Ascending Dose Clinical Trial of CardiolRx(TM). CardiolRx is a

pharmaceutically produced oral cannabidiol formulation being developed for

the treatment of acute and chronic inflammation associated with heart

disease. These results positively support Cardiol Therapeutics' proposed

treatment dosage for their upcoming CardiolRx Phase II and Phase II/III

trials. David Elsley, President and CEO of Cardiol Therapeutics, stated:

'Cardiol is initiating a Phase II/III clinical trial in the U.S.

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 we are planning to file an

Investigational New Drug 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.'

GBC AG: Mr. Elsley, first, we congratulate you for this achievement. To our

knowledge no other studies have incorporated such a high number of subjects

for single and multiple ascending dosing of high concentration cannabidiol.

Can you explain your decision to include over 52 participants?

David Elsley: To date, the clinical trials conducted with cannabidiol in

support of FDA approvals for the treatment of rare childhood epilepsies

have only involved children. It is therefore important to note that

Cardiol's study is one of the most comprehensive Phase I clinical trials

ever conducted in adults. Cardiol's study included fifty-two adult subjects

who received one of two doses of drug (5 mg/kg or 15 mg/kg of CardiolRx) in

both a non fed and fed state. Our study results demonstrated that when the

drug was taken with food, the blood levels of the drug were six to seven

times higher than when the drug was taken without food. This is an

important confirmatory finding as it supports our long-standing

recommendation that cannabidiol should be taken with food to optimize its

therapeutic potential. Cannabidiol is fat soluble, and when taken with

food, more drug reaches the blood circulation and becomes available to

target sites of disease. Furthermore, even at the very high doses

administered during our study, CardiolRx was shown to be safe and well

tolerated with no adverse impact on cardiac status or liver function.

GBC AG: These results allow Cardiol Therapeutics to move one step further

in the process of drug approval by the FDA. Can you give us more details on

the timeline for your two major clinical development programs?

David Elsley: We are currently initiating a landmark Phase II/III clinical

study in the United States in patients with cardiovascular disease (CVD),

or risk factors for CVD, who are hospitalized with COVID-19. In this study

we are investigating the anti-inflammatory and cardioprotective properties

of CardiolRx in these high-risk patients, who experience markedly elevated

risk for mortality and major cardiovascular complications, such as heart

attack or stroke. This potentially registrational trial will enroll 422

patients at clinical research centers throughout the U.S. We are also

preparing to explore the cardioprotective properties of CardiolRx in a

second inflammatory heart condition called acute myocarditis. Acute

myocarditis is a devasting disease that represents a leading cause of

sudden cardiac death in young healthy adults and children and for which

there is currently no recognized standard of care. Based on the successful

results of the Company's Phase I program, we are now preparing to file an

IND application with the FDA for a Phase II study in acute myocarditis; a

disease that is eligible for orphan drug fast-track designation in the

U.S., as it represents a life-threatening disease that affects less than

200,000 people in the United States. Importantly, GW Pharmaceuticals

utilized the U.S. orphan drug program to fast track the development of

cannabidiol for rare forms of pediatric epilepsy, and in 3.5 years

increased shareholder value by over US $6 billion.

GBC AG: When GW Pharmaceuticals, developer of the leading cannabidiol

epilepsies treatment Epidiolex, got acquired by Jazz Pharmaceutical for

over 7.2B USD, it served as a stamp of approval for new treatments based on

high dosages of cannabidiol. Do you believe that if CardiolRx got approval

for commercial production by the FDA to treat acute myocarditis, the

company could expect the same range of valuation or even higher?

David Elsley: The acute myocarditis market opportunity is essentially twice

the size of the market for rare epilepsies. The prevalence of the rare

pediatric epilepsies is about 37,000 each year, whereas the prevalence of

acute myocarditis is over 70,000 people. It is also important to note that

other treatments being investigated for acute myocarditis are extremely

expensive, with potential treatment costs in the range of USD $60,000. In

this context, the potential value of CardiolRx as a new drug for the

treatment of acute myocarditis is incredibly significant, as not only would

we have the opportunity to improve outcomes and quality of life for these

young patients, but we would also have an opportunity to save the

healthcare system the enormous expenses of treating patients in the

hospital.

GBC AG: When GW Pharmaceuticals conducted their Phase III trial for

Epidiolex, they had a total of 224 patients. Once again, your CardiolRx

Phase II/III Trial for patients with COVID-19 who have a prior history of,

or risk factors for cardiovascular disease will count twice as many

patients. Can you explain why you are embarking on such an important

clinical program?

David Elsley: Our Phase II/III trial has been designed to investigate the

impact of CardiolRx on the risk of mortality, major cardiovascular

complications, such as heart attack or stroke, and risk of progression to

intensive care or requirement for ventilatory support. In this context, we

have a unique opportunity to study a large patient population to determine

the ability of CardiolRx to affect the end result of disease, in addition

to studying the impact of our drug on a patient's symptoms, quality of

life, and other markers of disease progression. To demonstrate the impact

of a new medicine on significant clinical endpoints such as mortality or

morbidity, typically larger patient numbers are required and that is why

our U.S. study design includes more patients than the previous studies in

epilepsy you are referring to. The other benefit of using a larger number

of patients in our study is the potential for the trial results to support

both an emergency use authorization and an application for marketing

authorization for the treatment of high-risk COVID-19 patients.

GBC AG: How fast after the approval from the FDA could you commercialise

CardiolRx regarding COVID-19?

David Elsley: The FDA has provided emergency use authorization in a matter

of weeks after positive data for other treatments. To the extent that we

continue to see outbreaks around the world of COVID-19, we believe that

positive results form our Phase II/III program would also support an

emergency use authorization by the FDA and possibly other jurisdictions

around the world. Positive results from this study may also support a new

drug application for the treatment of patients with a prior history of

cardiovascular diseases who become COVID-19 positive as notwithstanding the

roll out of vaccines, we believe there will be a need for effective

therapies for high-risk COVID-19 patients well into the future.

GBC AG: Lastly, you surround yourself with a team of leading practicians in

the cardiovascular field. More specifically, one fact caught our attention:

Dr. Matthias Friedrich and Dr. Carsten Tschöpe both have strong links to

Germany and more precisely Berlin. Dr. Tschöpe is the Vice Director of the

Department of Internal Medicine and Cardiology at the University Medicine

Berlin and was awarded the prestigious Arthur Weber Prize by the German

Cardiac Society for his cardiovascular research. Dr. Friedrich founded one

of the first large Cardiovascular Magnetic Resonance centres in Germany at

the Charité University Hospital in Berlin. Can you explain us how Cardiol

Therapeutics and you personally came to have such strong ties with Germany?

David Elsley: Dr. Tschöpe is world renowned for his work in acute

myocarditis. At the Charité hospital in Berlin, he oversees one of the

largest myocarditis practices in all of Europe. Patients with acute

myocarditis are referred from all over Germany and Europe to the Charité.

Dr. Friedrich, who is now at McGill University Hospital in Montreal, also

spent many years in heart failure medicine at the Charité and he is also

internationally recognized for his work in electrophysiology in heart

disease. Inflammation increases your risk for abnormal heart rhythms which

can lead to ventricular tachycardia which can in turn result in sudden

cardiac death. Dr. Friedrich is an expert in looking at this aspect of

cardiac disease. In this regard, as heart disease does not respect borders

and affects people all around the world, we are extremely pleased that our

Steering Committee, which oversees the design of our clinical trial

programs, is made up of international specialists from Europe, the United

States, Canada, and Latin America.

GBC AG: CardiolRx's treatment of acute myocarditis would not fight the

cause, usually a virus infection, but would limit the direct damages

inflicted to the patient heart tissue. It could therefore limit the

possible cardiac failure and irreversible damage to the ventricular

function due to the myocardial tissue inflammation caused by the infection.

What is your treatment trying to achieve?

David Elsley: We developed CardiolRx for patients that need cardio

protection during the acute phase of disease. We envisage providing

patients with high doses of cannabidiol over a relatively short period of

time (30-60 days) to provide rapid onset cardio protection during the acute

or dangerous phase of the disease. In short, we believe this therapeutic

strategy can help protect heart tissue from the damage caused by

inflammation and therefore reduce the consequences of this disease and

significantly improve patients' quality of life.

GBC AG: Mr. Elsley, thank you very much for the interview.

Die vollständige Analyse können Sie hier downloaden:

http://www.more-ir.de/d/22347.pdf

Kontakt für Rückfragen

Jörg Grunwald

Vorstand

GBC AG

Halderstraße 27

86150 Augsburg

0821 / 241133 0

research@gbc-ag.de

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Date (time) of completion of English version: 22/04/2021 (12:33 pm)

Date (time) of first distribution of English version: 22/04/2021 (02:00 pm)

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