Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a biopharmaceutical
company focused on the development of therapeutic drugs for the
treatment of liver disease arising from non-alcoholic
steatohepatitis (“NASH”) and chronic viral infection, today
announced it entered into a research partnership with Applied
Pharmaceutical Innovation (“API”), an independent institute that
launched out of the Faculty of Pharmacy and Pharmaceutical Sciences
at the University of Alberta (“FPPS”) in Edmonton, Canada that is
focused on empowering the growth and development of the Canadian
pharmaceutical industry in collaboration with post-secondary
centers of excellence.
The partnership with API and FPPS greatly
expands Hepion Pharmaceuticals’ research capabilities, enabling
access to cutting edge expertise and facilities in an
industry-leading commercialization framework. As part of this
research partnership, Hepion Pharmaceuticals will immediately begin
recruiting post-doctoral fellows (“PDF”) to conduct animal imaging
studies examining the time course of the development of NASH and
fibrosis in various models; the effects of CRV431, the Company’s
lead drug candidate, in animal models of NASH; and to further
examine CRV431 in cellular assay systems.
“We previously announced that CRV431 has shown
anti-fibrotic activity in two separate animal models of NASH and
fibrosis in five independent studies and have further characterized
the performance of our molecule in phase 1 results in human
subjects,” commented Dr. Robert Foster, Hepion Pharmaceuticals’
CEO. “Now we will begin examining exactly what CRV431 is doing in
organs of animals using state-of-the art imaging techniques. These
imaging studies will be enhanced by digging further into the mode
of action of CRV431 on a molecular biology level and will
complement our current activities conducted in our own research
laboratories and clinical studies.
“Hepion is thrilled with the enhanced research
capabilities this partnership provides, and I am personally looking
forward to working with the University of Alberta again,” Dr.
Foster continued. “The University was supportive of my earlier
research that led to the development of voclosporin, which is
nearing a readout of Phase 3 trial data, as well as research that
has supported our team’s development of CRV431.”
Partial funding for the PDF positions on the
Hepion Pharmaceutical research program will be provided through a
$6 million collaboration between API and Mitacs, a Canadian Federal
Government industry matching program, to support translational
research in FPPS.
API and FPPS see partnership with Hepion
Pharmaceuticals as a major component of a growing movement to
better support innovation in Edmonton.
“Many past Canadian success stories in drug
development came out of our Faculty,” said FPPS Dean, Dr. Neal
Davies. “We are the only academic institution in Canada with a
Health Canada site license for Natural Health Products (NHP) and
the ability to do drug development in everything from cannabinoids
to radiopharmaceuticals. Our cutting edge GMP clean rooms and
manufacturing capacity for clinical trials, as well as our
extensive analytical infrastructure and animal facilities, are all
world class assets.”
“API launched to support and empower exactly
these sorts of collaborations,” commented API CEO, Andrew MacIsaac.
“For decades the Faculty of Pharmacy and Pharmaceutical Sciences
has been an extremely strong pipeline of talent for the
pharmaceutical industry internationally. We’re thrilled to be able
to leverage our abilities to support innovation here in Edmonton
and we continue to establish Alberta and Canada as a top
destination for drug development.”
API has worked closely with regional partners
such as the Edmonton Health City Initiative towards this goal, and
has partnerships with other centers of expertise, such as the
world-renowned Alberta Machine Intelligence Institute, that enable
it to establish the health ecosystem in Edmonton as one that is at
the global cutting edge. A partnership with Hepion Pharmaceuticals
will provide the Company with world class research infrastructure
and talent.
About Hepion
Pharmaceuticals
Hepion Pharmaceuticals is a clinical stage
biopharmaceutical company focused on the development of targeted
therapies for liver disease arising from non-alcoholic
steatohepatitis (NASH) and chronic hepatitis virus infection (HBV,
HCV, HDV). The company’s lead drug candidate, CRV431, reduces liver
fibrosis and hepatocellular carcinoma tumor burden in experimental
models of NASH. Preclinical studies also have demonstrated
antiviral activities towards HBV, HCV, and HDV through several
mechanisms. These diverse therapeutic activities result from
CRV431’s potent inhibition of cyclophilin enzymes, which are
involved in many disease processes. Currently in clinical phase
development, CRV431 shows potential to play an important role in
the overall treatment of liver disease—from triggering events
through to end-stage disease. For more information, please
visit www.hepionpharma.com.
About Applied Pharmaceutical
Innovation
API is a not-for-profit that works in
collaboration with the University of Alberta’s Faculty of Pharmacy
and Pharmaceutical Sciences as well as research and post-secondary
institutions across Canada. API draws on an interdisciplinary
network of over 30 pharmaceutical scientists, clinicians,
regulatory, patent, and market experts in a variety of fields and
disease areas to bring life-saving research to the real world. API
provides a framework to support industry projects in a manner that
keeps IP with the company, is regulatory compliant, and moves at a
commercial pace. Learn more about API at www.appliedpharma.ca.
About Faculty of Pharmacy and
Pharmaceutical Sciences
Serving as Alberta's sole pharmacy school since
1914, FPPS holds consistent rankings among the top three
institutions in Canada, top 50 globally, and top 15 for global
research. FPPS has 50 faculty members, 17 support staff members,
523 preceptors, 2,665 preceptor sites and extensive research
infrastructure. Its Katz Group Centre for Pharmacy and Health
Research was constructed at a cost of approximately $165 million
CAD, covering about 350,000 square feet, as part of a health
complex covering almost 750,000 square feet.
The University of Alberta was founded in 1908
and has over 40,000 students, 14,438 employees, 41.3 million
National Teaching Fellows, 75 Rhodes Scholars, and an annual
economic impact of $12.3 billion CAD.
Forward-Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimated,” and “intend,” among others.
These forward-looking statements are based on Hepion
Pharmaceuticals’ current expectations and actual results could
differ materially. There are several factors that could cause
actual events to differ materially from those indicated by such
forward-looking statements. These factors include, but are not
limited to, the design, progress and timing of preclinical and
clinical studies; substantial competition; our ability to continue
as a going concern; our need for additional financing;
uncertainties of patent protection and litigation; uncertainties
with respect to lengthy and expensive clinical trials; that results
of earlier studies and trials may not be predictive of future trial
results; uncertainties of government or third party payer
reimbursement; limited sales and marketing efforts and dependence
upon third parties; and risks related to failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations. As
with any drug candidates under development, there are significant
risks in the development, regulatory approval, and
commercialization of new products. There are no guarantees
that future clinical trials discussed in this press release will be
completed or successful, or that any product will receive
regulatory approval for any indication or prove to be commercially
successful. Hepion Pharmaceuticals does not undertake an obligation
to update or revise any forward-looking statement. Investors should
read the risk factors set forth in Hepion Pharmaceuticals’ Form
10-K for the year ended December 31, 2018 and other periodic
reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen KilmerHepion Pharmaceuticals Investor Relations(646)
274-3580skilmer@hepionpharma.com
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