Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH
November 30 2021 - 8:00AM
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 granted Fast Track designation for the Company’s lead drug
candidate, CRV431, for the treatment of NASH.
The FDA Fast Track designation allows sponsors
to gain access to expedited drug approval reviews for medical
conditions that are serious and potentially life-threatening, and
where there is an unmet medical need. The program is also designed
to facilitate drug development by making provisions for more
frequent meetings with the FDA to discuss drug development plans,
and Fast Track designation can lead to Accelerated Approval and/or
Priority Review eligibility if certain criteria are met.
“CRV431 has been investigated in healthy
subjects during our Phase 1 program, and more recently in subjects
with presumed F2 and F3 NASH in our Phase 2a AMBITION study,”
commented Todd Hobbs, MD, Hepion’s Chief Medical Officer.
“Administered once daily as an oral soft gel capsule, CRV431 has
been well-tolerated and has shown signals of efficacy in NASH in
this early Phase 2 study. We are now looking forward to initiating
our larger Phase 2b NASH study, called ‘ASCEND-NASH’, in biopsy
confirmed F2 and F3 NASH subjects in the coming months.”
Dr. Hobbs continued, “We are keenly aware that
there remains an urgent global need to develop NASH-specific
therapeutic drugs for this potentially life-threatening condition,
for which there are currently no FDA approved drugs. Furthermore,
the American Liver Foundation estimates that at least 5% of the
U.S. adult population has NASH. As such, we are very pleased to
receive the FDA’s Fast Track designation and are looking forward to
working closely with the Agency as we advance development of
CRV431.”
Robert Foster, PharmD, PhD, Hepion’s CEO, added,
“This Fast Track designation provides for early and frequent
communication with the FDA that will continue throughout the drug
development and review process, which may lead to a more expedited
drug approval and patient access to CRV431. Additionally, as part
of the FDA Fast Track designation for CRV431 in NASH, Hepion will
make its expanded access policy publicly available in the coming
weeks.”
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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