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”) and other liver diseases,
today announced that the U.S. Food and Drug Administration (“FDA”)
has accepted its investigational new drug (“IND”) application for
CRV431, a liver-targeting, novel cyclophilin inhibitor, for the
treatment of hepatocellular carcinoma (“HCC”).
On July 29, 2019, Hepion received FDA
authorization of an IND to initiate the study of CRV431 for the
treatment of NASH. To date, Hepion has completed Phase 1 studies in
healthy volunteers and, more recently, announced positive data from
its Phase 2a ‘AMBITION’ trial in subjects with presumed F2 and F3,
where CRV431 was well tolerated, and all primary endpoints were
met. A larger Phase 2b NASH study of over 300 subjects with paired
liver biopsies, called ‘ASCEND-NASH’, is expected to be initiated
in 2022. ASCEND-NASH will evaluate CRV431’s effects on the
histologic endpoints of liver steatosis and fibrosis over 12 months
dosing.
“Liver cancer is the sixth most prevalent cancer
worldwide and is the second most common cause of cancer death,”1
commented Todd Hobbs, MD, Hepion’s Chief Medical Officer. “The most
common form of liver cancer is HCC, which comprises about 90% of
all liver cancers. Major risk factors associated with development
of HCC include NASH, liver fibrosis and cirrhosis, viral hepatitis,
chronic alcohol consumption, and metabolic syndrome. As the global
prevalence of NASH is increasing, the incidence of HCC arising from
NASH is also increasing. Approximately 25% to 30% of NASH-related
HCC develops in the absence of cirrhosis and, therefore, occurs
without many of the symptomatic warning signs of this aggressive
form of cancer. An orally administered drug that simultaneously
targets NASH and HCC would offer an advantageous therapeutic
strategy to patients suffering these potentially life-threatening
conditions. CRV431’s novel potential stems from its pleiotropic
pharmacologic activities and from its ability to target the liver,
allowing for a drug candidate ideally suited for the treatment of
liver disease.”
Dr. Hobbs continued, “Another potentially
important benefit is the patient experience while taking CRV431.
Most cancer drugs are delivered by injection and are associated
with significant side effects. In contrast, CRV431 is orally
administered and has been shown to be well tolerated in clinical
trials to date. We are optimistic that CRV431 may provide
significant anti-cancer effects without imposing additional
challenges and distress often associated with cancer drugs.”
Robert Foster, PharmD, PhD, Hepion’s CEO, said,
“Increased cyclophilin isoform expression has been associated with
negative outcomes in HCC. Importantly, CRV431 potently inhibits
many of these isoforms in humans. Cyclophilins are enzymes that
regulate many molecular and cellular activities that become
dysregulated both in NASH and HCC. These dysregulated activities
can lead to aberrations in signal transduction pathways, cell
proliferation, cell death, extracellular environment including
increased fibrosis, energy metabolism, inflammation, and immunity.
Therapeutic intervention with CRV431 administration may reduce the
pathologic potential associated with heightened cyclophilin
activities in NASH and HCC, potentially allowing for a return to a
healthier state.”
Dr. Foster continued, “CRV431 has shown
anti-tumor activity in multiple animal studies, and our research
team has been intensively investigating the specific mechanisms
that have produced these outcomes. Our investigations have revealed
interesting direct and indirect effects of CRV431 on cancer cells
and tumors. For example, gene expression analyses have demonstrated
CRV431’s ability to attenuate drug-resistance pathways and
Wnt-β-catenin-Myc signaling, the latter being mutationally
over-activated in 30% to 50% of human HCC tumors. We recently
also found that CRV431 increased lymphocyte infiltration into liver
tumors in a manner similar to an immune checkpoint inhibitor, also
known as an anti-PD-1 antibody, which is considered to be an
important anti-tumor approach. We believe that the wide array of
pharmacologic activities offered by CRV431 in the treatment of NASH
and HCC should bode well for the further clinical development in
both important indications.”
Reference
1Hepatocellular Carcinoma. Nature Reviews Disease
Primers 7, 7 (2021).
About Hepion
Pharmaceuticals
The Company's lead drug candidate, CRV431, is a
potent inhibitor of cyclophilins, which are involved in many
disease processes. CRV431 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. CRV431 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.
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 CRV431, 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 CRV431 to expand the company's
footprint in the cyclophilin inhibition therapeutic space.
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, 2020,
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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