Health Canada Issues Resverlogix Authorization to Begin Immediate Clinical Studies of Apabetalone for COVID-19

Resverlogix Plans to Emulate the Pfizer and Moderna Models of Rapid Parallel Development use

CALGARY, Alberta, April 12, 2021 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix") (TSX:RVX) is pleased to announce that it has successfully received its desired “No Objection Letter” from Health Canada. It has approved the COVID-19 Clinical Trial Application for apabetalone. The planned Phase 2 trial will be an open-label study evaluating the safety and efficacy of oral apabetalone, in combination with standard of care for patients hospitalized with COVID-19. “Today’s exciting announcement is an important step in advancing apabetalone’s clinical development as a potentially highly effective therapeutic for COVID-19,” said Donald McCaffrey, President & CEO of Resverlogix. “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 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 twice daily doses of apabetalone for up to 4 weeks alongside standard of care or, alternatively, standard of care without apabetalone. The primary outcome measure of the study will be change in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. 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. A full study protocol will be posted to clinicaltrials.gov prior to initiation of the study.

Program Update

Apabetalone is an investigational, phase 3 clinical candidate with safety data in more than 4,000 subjects. Resverlogix has announced plans for an open-label study to assess the safety and efficacy of apabetalone in the treatment of COVID-19.

As previously announced, an article published on March 23, 2020 revealed the interaction between SARS-CoV-2 (COVID-19) protein E with BET proteins. Following this finding, Resverlogix put out a call for collaborations, resulting in multiple partnerships, and in parallel initiated in-house preclinical research to further characterize and investigate apabetalone’s efficacy in treating COVID-19 infection.