I’m Ebony North for Investmentpitch Media
Resverlogix Corp., a world leader in epigenetics, or gene regulation,
has begun enrollment and dosing of patients in a Phase 2b clinical trial
at a site at the University of Alberta Hospital in Edmonton,
to evaluate the safety and efficacy of apabetalone as a potential oral treatment for COVID-19.
Donald McCaffrey, President & CEO, stated: “Today is a landmark moment, as patients
suffering from COVID-19 are now receiving apabetalone treatment for the first time.
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."
Dr. Michael Sweeney, Senior VP, Clinical Development, added:
"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."
On March 23, 2020, following a publication in Nature, authored by a consortium of top
Universities and Research Institutions, Resverlogix launched a COVID-19 program,
conducting research internally and enlisting world-renowned collaborators.
Studies published in prestigious scientific journals demonstrated
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.
In this randomized, open-label trial, Phase 2b 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.
Resverlogix has partnered with EVERSANA ™, a 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 United States.
EVERSANA ™ is currently the leading clinical outreach and
advocacy for apabetalone in the Canadian market.
Founded in 2001, Resverlogix is a Calgary based late-stage biotechnology company
developing first-in-class therapies for the benefit of patients with chronic disease.
The company aims to improve patients’ lives by restoring biological functions – altered
by serious illnesses such as cardiovascular disease – back to a healthier state.
Resverlogix is commercializing a new class of epigenetic therapies designed to regulate gene
expression, turning disease-associated genes “on” or “off”, without changing the human DNA.
Apabetalone (RVX-208), is a first-in-class, small molecule that is a selective bromodomain
and extra-terminal, or BET, inhibitor, an epigenetic mechanism that can regulate
disease-causing genes therapeutic candidate with an epigenetic mechanism of action.
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 Food and Drug
Administration 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.
The shares are trading at $0.54.
For a more in depth explanation of this technology and this study,
please refer to the company’s news release, its website,
www.resverlogix.com, or contact the company at 403-254-9252 or by email at ir@resverlogix.com.