Resverlogix Corp. ("Resverlogix") (TSX:RVX) and QIMR Berghofer
Medical Research Institute (“QIMR Berghofer”), one of Australia’s
most successful medical research institutes, announced today the
publishing of a new article providing evidence of apabetalone’s
potential benefit on SARS-CoV-2 (COVID-19). The article, titled:
“Bromodomain and Extraterminal Inhibition Blocks
Inflammation-Induced Cardiac Dysfunction and SARS-CoV-2 Infection
(Pre-Clinical)”, was published on the pre-print server, bioRxiv, at
the request of the reviewing scientific journal.
The publication can be viewed using the
following LINK.
“We are excited that we can finally share
publicly some of the incredible early results of our collaborative
COVID-19 research program,” said Donald McCaffrey, President and
CEO of Resverlogix. “Not only does apabetalone treatment reduce
SARS-CoV-2 infection in cardiomyocytes, but it also prevents
cardiac dysfunction induced by cytokine-storm. These findings
showcase the unique dual-mechanism of apabetalone as a potential
therapeutic for COVID-19 and provide strong support for human
trials.”
“I would like to commend our collaborators at
QIMR Berghofer whom it has been a pleasure to work with,” said Dr.
Ewelina Kulikowski, Senior Vice President, Research &
Development at Resverlogix and a co-author of the article.
“Collaborations such as this serve to quickly move our research
forward for the benefit of patients.”
Repurposing Drugs to Treat
COVID-19
“Many re-purposed drugs have failed in clinical
trials for COVID-19,” said Associate Professor James Hudson, head
of the Cardiac Bioengineering Research Group at QIMR Berghofer. “We
sought a different approach to firstly understand mechanistically
how COVID-19 could be driving cardiac dysfunction seen in many
patients. After detailed studies we identified
bromodomain-containing protein 4 as a key mediator of dysfunction
and BET inhibitors were very effective at blocking this response.
In the pursuit to translate these findings to the clinic, we formed
a very exciting collaboration with Resverlogix to test apabetalone,
which we also found was very effective in our models. It was a
pleasure to work with Resverlogix and truly share information both
ways, and contribute data for the basis of their clinical
trials.”
Collaborative Support From Alberta
Government
“This is another great example of an
Alberta-based biotech company taking the fight to COVID-19,” said
Doug Schweitzer, Minister of Jobs, Economy and Innovation for
Alberta. “We have world-class researchers in our province that are
creating internationally recognized products to save lives around
the world. It is exciting to see this growing industry create
solutions and jobs for Albertans.”
Publication Highlights
include:
-
Cardiac dysfunction is known to result from COVID-19 infection,
increasing risk of mortality and serious complications
-
BET inhibitors, including apabetalone, were evaluated for their
ability to protect cardiac tissue from damage induced by
COVID-19
-
State-of-the-art models were employed, including human cardiac
organoids and mouse models of cytokine-storm
-
Apabetalone treatment was found to prevent cardiac dysfunction
caused by inflammation
-
Apabetalone treated heart cells showed decreased SARS-CoV-2
infectivity, and reduced expression of ACE2 (a receptor linked to
the virus’ entry into human cells)
-
In mouse models, BET inhibitors reduced cardiac injury resulting
from cytokine-storm which translated to survival of all animals in
the treatment group, compared to 75% mortality among the control
group
Program Update:
Apabetalone, a FDA granted Breakthrough Therapy
Designation (BTD) drug is an investigational, phase 3 clinical
candidate with safety data in more than 4,000 subjects. Resverlogix
has announced plans for an open-label study to assess the safety
and efficacy of apabetalone in the treatment of COVID-19.
As previously announced, an article published on
March 23, 2020 revealed the interaction between SARS-CoV-2
(COVID-19) protein E with BET proteins. Following this finding,
Resverlogix put out a call for collaborations, resulting in
multiple partnerships, and in parallel initiated in-house
preclinical research to further characterize and investigate
apabetalone’s efficacy in treating COVID-19 infection.
In October and December of 2020, Resverlogix
announced additional publications that shortlisted apabetalone for
its potential COVID-19 effectiveness, including in reducing
cytokine-storms.
The work featured in this article is currently
undergoing peer-review and is expected to be published in a
scientific journal shortly. Additional publications are expected to
result from ongoing COVID-19 research in the months to come.
About QIMR Berghofer
QIMR Berghofer is a world-leading, translational
medical research institute based in Brisbane, Australia. Its
research focuses on cancer, infectious diseases, mental health and
a range of chronic disorders. Working in close collaboration with
clinicians, other research institutes and the biotech sector, QIMR
Berghofer’s aim is to improve human health by developing new and
better diagnostics, treatments and prevention strategies.
About Resverlogix
Resverlogix is developing apabetalone (RVX-208),
a first-in-class, small molecule that is a selective BET
(bromodomain and extra-terminal) inhibitor. Apabetalone is the
first therapy of its kind to have been granted US FDA Breakthrough
Therapy Designation – for a major cardiovascular indication – to
help facilitate a time-efficient drug development program including
planned clinical trials and plans for expediting the manufacturing
development strategy.
BET inhibition is an epigenetic mechanism that
can regulate disease-causing genes. Apabetalone is a BET inhibitor
selective for the second bromodomain (BD2) within the BET proteins.
This selective inhibition of apabetalone on BD2 produces a specific
set of biological effects with potentially important benefits for
patients with high-risk cardiovascular disease, diabetes mellitus,
chronic kidney disease, end-stage renal disease treated with
hemodialysis, neurodegenerative disease, Fabry disease, peripheral
artery disease and other orphan diseases, while maintaining a well
described safety profile.
Resverlogix common shares trade on the Toronto Stock Exchange
(TSX:RVX).
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For further information please contact:
Investor RelationsEmail: ir@resverlogix.comPhone: 403-254-9252Or
visit our website: www.resverlogix.com
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 apabetalone as a potential
therapeutic for COVID-19 and the potential role of apabetalone in
the treatment of patients with cognitive disorders, high-risk
cardiovascular disease, diabetes mellitus, chronic kidney disease,
end-stage renal disease treated with hemodialysis, Fabry disease,
peripheral artery disease and other orphan diseases. Our actual
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