Hepion Pharmaceuticals Announces USAN Selection of “Rencofilstat” as Nonproprietary Name for CRV431
07 January 2022 - 8:15AM
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 the United States Adopted Names (“USAN”) Council
has adopted the nonproprietary name “rencofilstat” for the
Company’s lead drug candidate, CRV431.
The USAN Council (tri-sponsored by the American
Medical Association, the United States Pharmacopeia, and the
American Pharmacists Association) works closely with the
International Nonproprietary Name Programme of the World Health
Organization and various national nomenclature groups to achieve
global standardization and unification of drug nomenclature and
related rules with the goal of ensuring that drug information is
communicated accurately and unambiguously.
Going forward, Hepion will use the name
“rencofilstat” in upcoming publications and public statements, at
conferences and other forums, as the Company continues to advance
the drug’s clinical development.
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 encoflistat, 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 encoflistat 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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