Resverlogix Receives Ethics Approval for Canadian Sites in Apabetalone COVID-19 Clinical Trial
12 Octubre 2021 - 3:35PM
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX), today
announces the approval of its COVID-19 clinical trial of
apabetalone by the Health Research Ethics Board (HREB) – Biomedical
Panel at the University of Alberta. This approval allows for
recruitment in the trial to commence.
“The ethics board approval is an important step towards bringing
apabetalone to market to help fight the ongoing COVID-19 pandemic,”
said Donald McCaffrey, Resverlogix’s President & CEO. “The
approved trial design closely follows the World Health
Organization’s blueprint for best practices in COVID-19 clinical
trials, and meets all requirements to safely and ethically evaluate
apabetalone as a potential new therapy.”
The Health Research Ethics Board assesses all matters required
by section 50(1)(a) of the Health Information Act. Subject consent
for access to identifiable health information is required for the
research described in the ethics application, and appropriate
procedures for such consent have been approved by the HREB -
Biomedical Panel.The final authorization from the HREB – Biomedical
Panel consisted of the evaluation of 12 complex required documents,
including: approved protocol, patient consent forms, investigator
brochures/product monographs, and the Health Canada no objection
letter, to name a few.
Trial Overview
Study participants will be made up of patients hospitalized with
confirmed COVID-19 cases. Participants will either receive twice
daily doses of apabetalone for up to 4 weeks alongside standard of
care, compared to standard of care alone. The primary outcome
measure of the study will be change in the World Health
Organization (WHO) Ordinal Scale for Clinical Improvement. A total
of 100 patients are expected to be enrolled at multiple sites in
Canada and Brazil. The full study protocol can be found on
clinicaltrials.gov.
About Apabetalone
Apabetalone (RVX-208), is a first-in-class, epigenetic small
molecule, or gene regulating, therapeutic candidate. It is a
selective BET (bromodomain and
extra-terminal) inhibitor, which
works in preventing disease by turning genes on and/or off through
regulation of gene expression. The prevalence of BET proteins
in the human body allows apabetalone, through its unique
mechanism of action, to simultaneously target multiple
disease-causing biological processes while maintaining a well
described safety profile – leading to a new way to treat chronic
disease.
Cardiology:
In February 2020, apabetalone became the first therapy of its
kind to receive Breakthrough Therapy Designation by the US Food and
Drug Administration (FDA) – for a major cardiovascular indication –
following the groundbreaking findings from the BETonMACE Phase
Three 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.
Covid-19:
On March 23, 2020, Resverlogix launched its
COVID-19 program, enlisting world-renowned collaborators. Studies
demonstrate that apabetalone has the potential to act against
COVID-19 with a unique dual-mechanism: the first pillar of
apabetalone’s dual-mechanism is preventing viruses from entering
the cells and replicating; the second pillar is averting runaway
inflammatory reactions that can cause severe and lasting organ
damage. A Phase Two clinical trial is evaluating apabetalone in
combination with standard of care for patients hospitalized with
COVID-19. Apabetalone treatment could potentially reduce the
severity and duration of COVID-19. Apabetalone’s unique
dual-mechanism also means that it is likely to show efficacy
against COVID-19 variants and may even help fight other related
viruses.
Apabetalone is the only drug of its class with a
well-established safety record in human clinical trials, with well
over 4200 patient-years on drug across 10 clinical trials.
About Resverlogix
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 gene expression, turning
disease-associated genes “on” or “off”. 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.
Resverlogix common shares trade on the Toronto Stock Exchange
(TSX:RVX).
Follow us: Twitter: @Resverlogix_RVX. LinkedIn:
https://www.linkedin.com/company/resverlogix-corp-/
Forward Looking Statements:
This news release may contain certain
forward-looking information as defined under applicable Canadian
securities legislation, that are not based on historical fact,
including without limitation statements containing the words
"believes", "anticipates", "plans", "intends", "will", "should",
"expects", "continue", "estimate", "forecasts" and other similar
expressions. In particular, this news release includes forward
looking information related to the potential role of Apabetalone in
the treatment of patients with COVID-19 (and potentially other
viruses), cardiovascular disease and associated comorbidities and
other chronic diseases. Our actual results, events or developments
could be materially different from those expressed or implied by
these forward-looking statements. We can give no assurance that any
of the events or expectations will occur or be realized. By their
nature, forward-looking statements are subject to numerous
assumptions and risk factors including those discussed in our
Annual Information Form and most recent MD&A which are
incorporated herein by reference and are available through SEDAR at
www.sedar.com. The forward-looking statements contained in this
news release are expressly qualified by this cautionary statement
and are made as of the date hereof. The Company disclaims any
intention and has no obligation or responsibility, except as
required by law, to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
For further information please contact:
Investor RelationsEmail:
ir@resverlogix.comPhone:
403-254-9252www.resverlogix.com
Resverlogix (TSX:RVX)
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