Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage
biopharmaceutical company focused on Artificial Intelligence
(“AI”)-driven therapeutic drug development for the treatment of
non-alcoholic steatohepatitis (“NASH”), Hepatocellular Carcinoma
(“HCC”), and other chronic liver diseases, today announced that it
has entered into a clinical collaboration with HepQuant, a
Denver-based, privately held company with novel, proprietary
investigational technology for evaluating liver function and health
in patients with chronic liver diseases. Hepion will incorporate
the HepQuant ‘SHUNT’ test into a dedicated Phase 2b clinical trial
in presumed NASH F3 subjects, initiating in Q3 of this year.
Hepion will evaluate three doses of rencofilstat
(CRV431) in 60 presumed NASH F3 subjects using the HepQuant SHUNT
test along with numerous NASH biomarkers collected over four months
of once daily oral dosing. HepQuant’s SHUNT test may provide a
sensitive measurement of hepatic function and is designed to
provide detailed information on the role rencofilstat plays in
improving the liver health in NASH subjects with advanced
fibrosis.
This trial will supplement the Company’s larger
12-month Phase 2b NASH clinical trial in biopsy-proven F2/F3 NASH
subjects (‘ASCEND-NASH’), which will begin in Q3 of this year; and
will run concurrently with Hepion’s ongoing Phase 2a clinical trial
for hepatocellular carcinoma (“HCC”).
“Challenges in conducting liver biopsies in NASH
clinical programs are well recognized, so we are impressed with the
SHUNT test’s potential to indicate changes in liver health over
short periods of time, and even potentially replace the need for
biopsy in NASH trials,” commented Todd Hobbs, MD, Hepion’s Chief
Medical Officer. “The HepQuant SHUNT test will allow us to collect
significant data on rencofilstat’s impact on hepatic function after
a four-month dosing period, much longer than that of our Phase 2a
AMBITION trial that was completed last year. We are looking forward
to gaining added confidence in rencofilstat’s ability to improve
fibrosis in NASH patients as we begin our larger Phase 2b biopsy
trial in parallel.”
HepQuant’s CEO and Chief Medical Officer, Greg
Everson, MD commented, “The noninvasive, blood-based HepQuant SHUNT
test of liver function and physiology addresses the unmet need for
an endpoint that directly quantifies liver health in liver
therapeutic trials. In many ways, HepQuant SHUNT is to the liver as
creatinine clearance is to the kidney – as HepQuant SHUNT worsens,
the likelihood of clinical complications or clinical outcomes of
liver disease increases. We have used the test in studies of HCV,
HCC, NASH, PSC, cirrhosis; and in interventional trials in HCV,
NASH, and HCC. Our research suggests that HepQuant SHUNT could be a
useful tool for detecting early treatment effects, dose response,
target engagement, and time of onset of action of drugs or
treatments.”
Robert Foster, PharmD, PhD, Hepion’s CEO,
commented, “Our mandate at Hepion is to provide answers to
transformative questions as quickly as possible. We recognize that
our Phase 2b ASCEND-NASH trial will take time to generate results,
as we need to account for subject recruitment and subsequent dosing
of rencofilstat for 12 months before the final study read-out. In
the meantime, however, we believe HepQuant’s technology will enable
us to determine the impact of rencofilstat on liver function in an
expeditious manner, with accelerated clinical read-outs compared
with the Phase 2b ASCEND-NASH study. As biopsy studies are a
requirement of regulators, Hepion will conduct both the paired
biopsy ASCEND-NASH trial and the HepQuant trial simultaneously; the
latter providing important answers in a shorter timeframe.
About Hepion
Pharmaceuticals
The Company's lead drug candidate, rencofilstat,
is a potent inhibitor of cyclophilins, which are involved in many
disease processes. Rencofilstat is currently in clinical-phase
development for the treatment of NASH, with the potential to play
an important role in the overall treatment of liver disease - from
triggering events through to end-stage disease. Rencofilstat has
been shown to reduce liver fibrosis and hepatocellular carcinoma
tumor burden in experimental models of NASH, and has demonstrated
antiviral activities towards HBV, HCV, and HDV through several
mechanisms, in nonclinical studies. In November 2021, the U.S. Food
and Drug Administration (“FDA”) granted Fast Track designation for
rencofilstat for the treatment of NASH. That was soon followed in
December 2021 by the FDA’s acceptance of Hepion’s investigational
new drug (IND) application for rencofilstat for the treatment of
hepatocellular carcinoma (HCC).
Hepion has created a proprietary AI platform,
called AI-POWR™, which stands for Artificial
Intelligence - Precision Medicine;
Omics (including genomics, proteomics,
metabolomics, transcriptomics, and lipidomics);
World database access; and
Response and clinical outcomes. Hepion intends to
use AI-POWR™ to help identify which NASH patients will best respond
to rencofilstat, potentially shortening development timelines and
increasing the delta between placebo and treatment groups. In
addition to using AI-POWR™ to drive its ongoing NASH clinical
development program, Hepion intends to use the platform to identify
additional potential indications for rencofilstat to expand the
company's footprint in the cyclophilin inhibition therapeutic
space.
About HepQuant
Headquartered in Denver, Colorado, HepQuant,
LLC, is a privately-held diagnostics company. HepQuant’s products
are investigational combination drug and in-vitro diagnostic
devices and have not yet been evaluated or reviewed by the US Food
and Drug Administration (FDA) for commercial sale. They are
currently available for investigational use via the FDA guidelines
for investigational device exemptions (IDEs). For additional
information, visit www.hepquant.com
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 a number of 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, substantial competition; our ability to continue as a
going concern; our need for additional financing; uncertainties of
patent protection and litigation; risks associated with delays,
increased costs and funding shortages caused by the COVID-19
pandemic; 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, 2021,
and other periodic reports filed with the Securities and Exchange
Commission.
For further information, please contact:
Stephen KilmerHepion Pharmaceuticals Investor
RelationsDirect: (646)
274-3580skilmer@hepionpharma.com
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