Resverlogix Confirms Focus on Treatment of Post COVID-19 Conditions
28 September 2022 - 1:12PM
Resverlogix Corp. ("Resverlogix" or the “Company”) (TSX:RVX) today
announced that apabetalone’s future clinical development related to
COVID-19 will focus on the prevention and treatment of Post
COVID-19 Conditions (PCC), colloquially known as long-COVID, as
opposed to hospitalized COVID-19 patients, reflecting the
compelling opportunity for apabetalone to benefit PCC patients and
guidance from the US Food and Drug Administration (FDA).
A recent estimate from the US Centers for Disease
Control and Prevention (CDC) suggests that as many as one-in-three
US adults may experience long-COVID after contracting COVID-19.
Vaccination against COVID-19 helps reduce the risk of PCC, but only
by as little as 15%, according to a recent study of more than 13
million people.
“Patients around the world are dealing with
persistent COVID-19 symptoms, often lasting weeks and months after
their initial infections,” said Dr. Michael Sweeney, Senior Vice
President, Clinical Development at Resverlogix. “There are
currently few available treatment options for this group of people,
and we feel that apabetalone has great potential to help them. We
know that individuals who contract COVID-19 are at greater risk of
negative cardiovascular outcomes, and we have seen the
cardioprotective benefit of apabetalone in other high-risk
populations.”
Regarding the recent FDA meeting, Dr. Sweeney
added: “We are grateful to the FDA for the feedback and suggestions
provided in our recent Type C meeting, and we look forward to
continuing to work with regulators in our evaluation of
apabetalone’s safety and efficacy in treating Post COVID-19
Conditions.”
The Company is finalizing the Phase 3 study
protocol of apabetalone in PCC and plans to launch the trial in the
first half of 2023, subject to all necessary regulatory and other
applicable approvals and securing the necessary resources.
About Apabetalone
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 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 of safety data
across 10 clinical trials.
COVID-19:
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. The
investigational treatment could potentially reduce the severity and
duration of post COVID-19 conditions. 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 global commercialization of
apabetalone for COVID-19. EVERSANA™ is currently leading clinical
outreach and advocacy for apabetalone.
Cardiology:
Apabetalone is 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.
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 developing 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.
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 Company’s planned COVID-19 trial
and the potential role of apabetalone in the treatment of patients
with COVID-19, 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
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