Resverlogix has expanded the Phase IIb clinical trial for analysing apabetalone (RVX-208) as a potential oral Covid-19 therapy to Brazil.
Apart from the first site launched in Brazil, the company initiated a second trial centre in Calgary city in the Canadian province of Alberta.
Five more study centres in Brazil as well as a third Canadian site in Toronto, Ontario will become operational soon.
A small-molecule treatment candidate, apabetalone has an epigenetic mechanism of action.
This bromodomain (BD2) selective bromodomain and extra-terminal (BET) inhibitor acts by modulating disease-causing gene expression to prevent and treat disease progression.
The open-label, randomised Phase IIb trial will analyse the safety and efficacy of apabetalone to potentially treat Covid-19.
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In the trial, subjects will be given either oral, twice-daily doses of apabetalone or standard of care alone.
The company expects to enrol 100 patients in the coming weeks at various study centres in Brazil and Canada.
A variation in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement will be the primary outcome measure of trial.
The WHO Ordinal Scale for Clinical Improvement is a standardised approach of evaluating the severity of Covid-19 on an eight-point scale.
Assessing the impact of apabetalone on biomarkers of inflammation will be included as the trial’s secondary endpoints.
Resverlogix president and CEO Donald McCaffrey said: “We are excited to be collaborating with Brazil on our Phase IIb clinical study, as part of our active and ongoing work with hospitals and ministries globally, to enrol and dose patients in our Covid-19 clinical trials.
“In consultation with Health Canada, we’ve updated our study protocol to account for the new variants, which could positively enhance the swiftness of patient enrolment.”
In January this year, the company commenced participant enrolment and dosing in the Phase IIb trial of apabetalone for Covid-19 in Canada.