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Resverlogix receives approval from Health Canada for its COVID-19 Clinical Trial Application for apabetalone

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With receipt of this “No Objection Letter” from Health Canada, the company can begin its planned Phase 2 trial, an open-label study evaluating the safety and efficacy of oral apabetalone, in combination with standard of care for patients hospitalized with COVID-19.

Additional Information:

Company: Resverlogix Corp.
Website: http://www.resverlogix.com
Stock Symbol: TSX: RVX
Date Published: Apr 12, 2021
Transcript: Available

Video Transcript:

I’m Megan Edwards for Investmentpitch Media

Resverlogix Corp., a pioneer in the landscape of epigenetics, has received approval from Health Canada for its COVID-19 Clinical Trial Application for apabetalone.

With receipt of this “No Objection Letter” from Health Canada, the company can begin its planned Phase 2 trial, an open-label study evaluating the safety and efficacy of oral apabetalone, in combination with standard of care for patients hospitalized with COVID-19.

Donald McCaffrey, President & CEO, stated: “Today’s exciting announcement is an important step in advancing apabetalone’s clinical development as a potentially highly effective therapeutic for COVID-19. We are grateful to Heath Canada for their expeditious review and approval of our application. We will continue working closely with regulators to bring apabetalone to market for the benefit of patients worldwide.”

Resverlogix is developing apabetalone, a first-in-class, small molecule that is a selective bromodomain and extra-terminal, or BET, inhibitor.

Apabetalone is an investigational, phase 3 clinical candidate with safety data in more than 4,000 subjects.

The results of collaborative research efforts have uncovered that apabetalone has the potential to combat COVID-19 through a unique dual mechanism.

First, apabetalone treatment prevents SARS-CoV-2 from infecting human cells, and second it reduces the inflammation and cytokine storm response which can result in organ damage and long-term negative impacts.

As a result of its dual mechanism and clinical safety record, several peer-reviewed publications have shortlisted apabetalone as a clinical candidate for COVID-19.

Resverlogix plans to advance the clinical and manufacturing programs in parallel as was successfully achieved with both the Pfizer and Moderna vaccine programs.

Study participants will either receive regular standard of care or regular standard of care along with doses of apabetalone twice a day for up to 4 weeks.

A total of 100 patients are expected to be enrolled at multiple sites, both in Canada and abroad and enrollment is expected to begin immediately.

The primary outcome measure of the study will be change in the World Health Organization Ordinal Scale for Clinical Improvement.

A full study protocol will be posted to www.clinicaltrials.gov prior to initiation of the study.

Apabetalone is the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation – for a major cardiovascular indication – to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy.

The prevalence of BET proteins in the human body allows apabetalone to simultaneously target multiple disease-causing biological processes, leading a new paradigm shift in the treatment of chronic disease.

This treatment offers potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease and others.

The shares are trading at $0.93.

For more information, please visit the company’s website, www.resverlogix.com contact Paul Moon, Investor Relations at 403-254-9252 or by email at ir@resverlogix.com

I’m Megan Edwards for Investmentpitch Media