Commencement of Patient Enrollment/Dosing in Phase 2b trial CALGARY, Alberta, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix") (TSX:RVX) is pleased to announce today that enrollment and dosing of patients has commenced in a Phase 2b study at a site at the University of Alberta Hospital in Edmonton. The trial will evaluate the safety and efficacy of apabetalone as a potential oral treatment for COVID-19.
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.
“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.”
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.
“In addition to reducing the duration of the disease, the hope is that apabetalone will also potentially be able to protect those infected from the effects of chronic COVID-19 – often referred to as long-COVID – experienced months after the initial illness,” said Dr. Michael Sweeney, Senior Vice President, Clinical Development at Resverlogix.
https://www.globenewswire.com/news-release/2022/01/18/2368307/0/en/Resverlogix-Announces-Commencement-of-Patient-Enrollment-and-Dosing-in-a-Phase-2b-Trial-for-a-Promising-Canadian-Developed-COVID-19-Treatment.html