CALGARY – Resverlogix Corp. (TSX: RVX) reported 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.
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.
The results of the 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 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.
BET inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well-described safety profile.
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
We seek Safe Harbor.