Resverlogix has initiated subject enrolment and dosing in a Phase IIb clinical trial of its small molecule therapeutic candidate, apabetalone (RVX-208), as a possible oral therapy to treat Covid-19.
The open-label, randomised trial will analyse apabetalone’s efficacy and safety to treat Covid-19 enrolling 100 subjects at various centres in Canada and Brazil.
According to its ClinicalTrials.gov listing, the trial is enrolling patients who have been admitted to hospital with symptoms suggestive of Covid-19 and 10 days or less since the onset of symptoms.
Trial subjects will be given either twice a day oral doses of apabetalone or standard of care alone.
Variation in the WHO Ordinal Scale for Clinical Improvement, a standardised approach to evaluate the severity of Covid-19 on an eight-point scale, will be the primary outcome measure of the trial.
Analysing apabetalone’s effect on inflammation biomarkers will be included as secondary endpoints. The trial was commenced at a centre at the University of Alberta Hospital in Canada.
An inhibitor of bromodomain (BD2) selective bromodomain and extra-terminal (BET), apabetalone has a dual epigenetic mechanism. It could aid in preventing the progression of the disease by modifying its expression and inflammation triggering genes, without any alteration to the DNA.
With this mechanism, the therapeutic candidate could address viral as well as deadly inflammatory features of Covid-19.
Resverlogix president and CEO Donald McCaffrey said: “Additional Canadian sites in Calgary and Toronto will soon be coming online, as well as four new sites in Brazil, that will receive apabetalone supply this week.
“Due to the emergence of the Omicron variant, and the speed with which it has spread, adaptations to the trial have been made to greatly expedite full enrolment.
“A positive outcome in this trial will enable us to move quickly to deliver apabetalone to patients in need globally, thus providing critical and affordable help in the fight against the ongoing pandemic.”
In October last year, the company received approval from the Health Research Ethics Board (HREB) – Biomedical Panel at the University of Alberta to start a trial of apabetalone for Covid-19 in the country.