Resverlogix has obtained approval from the Health Research Ethics Board (HREB) – Biomedical Panel at the University of Alberta in Canada to commence a clinical trial of its new therapy, apabetalone (RVX-208), for Covid-19 in the country.
With the approval, the company can now start enrolling subjects in the trial.
An epigenetic small molecule, or gene-regulating therapeutic candidate, apabetalone can selectively inhibit bromodomain and extra-terminal (BET).
It aids in disease prevention by regulating gene expression by turning on and/or off genes.
The open-label, exploratory trial will analyse the safety and effect on the clinical course of oral apabetalone in Covid-19 patients in the hospital.
It plans to enrol a total of 100 adult subjects aged 18 years and above at several trial centres in Canada and Brazil.
Subjects will be given either twice-daily doses of apabetalone for up to four weeks plus standard of care or standard of care alone.
The change in the World Health Organization Ordinal Scale for Clinical Improvement will be the trial’s primary goal.
Resverlogix president and CEO Donald McCaffrey said: “The ethics board approval is an important step towards bringing apabetalone to market to help fight the ongoing Covid-19 pandemic.
“The approved trial design closely follows the World Health Organization’s blueprint for best practices in Covid-19 clinical trials and meets all requirements to safely and ethically evaluate apabetalone as a potential new therapy.”
The company noted that apabetalone is the only therapy of its class to possess a well-established safety record in human trials, with more than 4,200 patient-years on drugs across ten trials.
According to the studies, apabetalone can potentially target SARS-CoV-2 with a peculiar dual-mechanism of preventing viral entry to cells and its replication, and by stopping runaway inflammatory reactions.