leadf
logo-loader
viewCardiol Therapeutics

Cardiol Therapeutics completes Phase I trial of lead drug CardiolRx

Cardiol said that the treatment was “generally well tolerated” with no serious adverse events reported in the 51 subjects that completed all requirements of the study protocol

Cardiol Therapeutics -
Full results from Phase I are expected in early 2021

Cardiol Therapeutics Inc (TSE:CRDL) (OTCQX:CRTPF) has completed its Phase I clinical study of its lead drug CardiolRx, it announced Tuesday.

CardiolRx is an ultra-pure, extra strength cannabidiol oral formulation that is pharmaceutically produced, manufactured under cGMP, and THC-free (less than 10 ppm).

During Phase I – a double-blind, placebo-controlled randomized study – participants received single, then multiple day ascending doses of CardiolRx administered orally, both in the fasting and fed states.

READ: Cardiol Therapeutics selects Worldwide Clinical Trials as its CRO for Phase II/III study of CardiolRx

In a statement, Cardiol said that the treatment was “generally well tolerated” with no serious adverse events reported in the 51 subjects that completed all requirements of the study protocol.

Phase I will help determine optimal dosing levels through measuring standard safety parameters and the pharmacokinetics of the treatment, including the degree of drug absorption and resulting blood levels at higher doses, the Oakville-based firm told shareholders.

Full results from Phase I are expected in early 2021.

The data will form a key part of Cardiol’s planned investigational new drug (IND) application with the US Food and Drug Administration for an international Phase II trial in acute myocarditis, an inflammatory heart condition that can lead to sudden death in otherwise healthy children and adults.

“Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, the company believes there is an opportunity to develop a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an orphan drug,” Cardiol said in a statement.

In the US, orphan drug designations are given to pharmaceuticals being developed to treat conditions that affect less than 200,000 people. The status means CardiolRx would be eligible for accelerated marketing approvals and other incentives such as longer market exclusivity in the US and the European Union.

Cardiol is a clinical-stage biotechnology company that is developing anti-inflammatory therapies to treat cardiovascular disease.

Contact Angela at angela@proactiveinvestors.com

Follow her on Twitter @AHarmantas

Quick facts: Cardiol Therapeutics

Price: 4.19 CAD

TSX:CRDL
Market: TSX
Market Cap: $137.81 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of Cardiol Therapeutics named herein, including the promotion by the Company of Cardiol Therapeutics in any Content on the Site, the Company...

FOR OUR FULL DISCLAIMER CLICK HERE

Cardiol Therapeutics sees positives for company after GW Pharma and Jazz...

Cardiol Therapeutics (TSE: CRDL- OTCQX: CRTPF) CEO David Elsley joined Steve Darling to offer his perspective on Jazz Pharmaceuticals acquiring GW Pharma for 7.2 billion dollars. Elsley talks about what that means for the CBD Pharma industry and what it could potentially mean for Cardiol...

3 weeks, 6 days ago

2 min read