- Health Canada has approved Resverlogix’s COVID-19 Clinical Trial Application for apabetalone
- A total of 100 patients are expected to be enrolled in the clinical study, both in Canada and abroad
- Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor
- Resverlogix Corp clinical-stage biotechnology company
- Resverlogix Corp. (RVX) opened trading at C$0.86 per share
Resverlogix Corp. (RVX) is pleased to announce that Health Canada 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 Health 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 standard of care without apabetalone. The primary outcome of the study will be measured by the WHO Ordinal Scale for Clinical Improvement.
A total of 100 patients are expected to be enrolled, both in Canada and abroad. The enrollment is expected to begin immediately.
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.
An article published in March 2020 revealed the interaction between SARS-CoV-2 (COVID-19) protein E and BET proteins. Following this finding, Resverlogix put out a call for collaborations, resulting in multiple partnerships, and initiated in-house preclinical research to further characterize and investigate apabetalone’s efficacy in treating COVID-19 infection.
The results of the collaborative research efforts have uncovered that apabetalone has the potential to combat COVID-19.
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor.
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.
Resverlogix Corp clinical-stage biotechnology company.
Resverlogix Corp. (RVX) opened trading at C$0.86 per share.