COVID-19 affects not only lung and respiratory tissue but can injure your heart as well. One study, published in the Journal of the American Medical Association, found that 78% of recently recovered COVID-19 patients had evidence of cardiac inflammation. A Calgary based therapeutics company was given FDA approval last year to fast track, granting the drug as “breakthrough technology” and will now enter the next patient trial phase.
Resverlogix is a Canadian pioneer in the landscape of epigenetics. The discovered, apabetalone in 2006 which is a new class of drugs designed to regulate gene expression through the inhibition of bromodomain and extraterminal domain (BET) proteins. The company believes it can improve the lives of patients by restoring biological functions that are altered by serious illnesses, such as cardiovascular disease, to a healthy state.
The company announced that enrollment and dosing of patients has commenced in a Phase 2b study at a site at the University of Alberta Hospital in Edmonton for its COVID-19 trials. The trial will evaluate the safety and efficacy of apabetalone as a potential oral treatment for the disease.
Apabetalone’s unique dual epigenetic mechanism may help stop disease progression by regulating the expression of disease and inflammation causing genes, without altering DNA. Through this mechanism, apabetalone has the potential to address both the viral and the more deadly inflammatory aspects of COVID-19.
Resverlogix Announces Commencement of Patient Enrollment and Dosing in a Phase 2b Trial
“Today is a landmark moment, as patients suffering from COVID-19 are now receiving apabetalone treatment for the first time,” said Donald McCaffrey, President & CEO of Resverlogix.
“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 enrollment. 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.”, said McCafferey.
In the randomized, open-label trial, study participants will either receive twice daily oral doses of apabetalone or, alternatively, standard of care alone. A total of 100 patients are expected to be enrolled over the coming weeks, at multiple sites in Brazil and Canada. The primary outcome measure of the study will be a change in the WHO Ordinal Scale for Clinical Improvement – a standardized method of assessing COVID-19 disease severity on an 8-point scale. Secondary endpoints will include evaluating the effect of apabetalone on biomarkers of inflammation.
A summary of the study protocol can be viewed HERE.