Resverlogix Announces Commencement of Patient Enrollment & Dosing in a Phase 2b Trial for a Promising Canadian-Developed COVID-19 Treatment

Resverlogix Corp. recently announced 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.

Apabetalone (RVX-208), is a first-in-class, small molecule, therapeutic candidate with an epigenetic mechanism of action. It is a BD2 (bromodomain) selective BET (bromodomain and extra-terminal) inhibitor that works in preventing and treating disease progression by regulating the expression of disease-causing genes.

Due to the extensive role for BET proteins in the human body, apabetalone, can simultaneously target multiple disease-related biological processes while maintaining a well-described safety profile – leading to a new way to treat chronic disease. Apabetalone received Breakthrough Therapy Designation from the US FDA, and is the only drug of its class with an established safety record in human clinical trials, with well over 4200 patient-years on drug across 10 clinical trials.

Following a publication in Nature, authored by a consortium of top Universities and Research Institutions, on March 23, 2020, Resverlogix launched a COVID-19 program, conducting research internally and enlisting world-renowned collaborators. Studies – published in prestigious scientific journals (including Cell) – demonstrate that apabetalone has the potential to act against COVID-19 with a unique dual-mechanism: first by preventing viruses from entering the cells and replicating; and second by averting excessive inflammatory reactions that can cause severe and lasting organ damage.

A Phase 2b clinical trial is evaluating apabetalone in combination with standard of care for patients hospitalized with COVID-19. The investigational treatment could potentially reduce the severity and duration of COVID-19. Apabetalone’s unique dual-mechanism also means that it has the potential to show efficacy against new COVID-19 variants and may even help fight other viruses.

Resverlogix has partnered with EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, to support the rapid commercialization of apabetalone for COVID-19 in Canada and the US. EVERSANA is currently leading clinical outreach and advocacy for apabetalone in the Canadian market.

In February 2020, apabetalone became the first therapy of its kind to receive Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) – for a major cardiovascular indication – following the ground-breaking findings from the BETonMACE Phase 3 study. Data from BETonMACE showed apabetalone can potentially prevent major adverse cardiac events among high-risk cardiovascular disease patients who also have type 2 diabetes mellitus.

Founded in 2001, Resverlogix is a Calgary based late-stage biotechnology company and the world leader in epigenetics, or gene regulation, with the goal of developing first-in-class therapies for the benefit of patients with chronic disease. Resverlogix is commercializing a new class of epigenetic therapies designed to regulate the expression of disease-causing genes. We aim to improve patients’ lives by restoring biological functions – altered by serious illnesses such as cardiovascular disease – back to a healthier state. The company’s clinical program is focused on evaluating the lead epigenetic candidate apabetalone for the treatment of cardiovascular disease and associated comorbidities, and COVID-19.