Hepion Pharmaceuticals Receives FDA Authorization to Proceed with IND Opening Study of CRV431 for NASH
July 29 2019 - 4:15PM
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 that the U.S. Food and Drug Administration (“FDA”) has
reviewed its Investigational New Drug (“IND”) application for
CRV431 for the treatment of NASH and has authorized that the
Company proceed with its planned IND opening study. This IND for
NASH is in addition to the Company’s current open IND for hepatitis
B virus (“HBV”).
“We are delighted that the FDA has cleared our
IND and we are excited to commence clinical trials of CRV431 for
NASH, an increasingly prevalent disease for which there are
currently no approved therapies,” commented Dr. Robert Foster, the
Company’s CEO. “Based on the preclinical and clinical studies we’ve
conducted, CRV431’s anti-fibrotic and anti-inflammatory properties
demonstrate its significant potential as a novel therapy for NASH,
and more broadly, for liver disease.”
“This is an important milestone that allows us
to continue with CRV431’s clinical development for NASH in addition
to HBV. We look forward to commencing our IND opening study this
year, which will assess CRV431 in patients with varying degrees of
hepatic impairment.”
Hepion’s planned IND opening study, entitled “An
Open-Label Single-Dose Study to Investigate the Effect of Hepatic
Impairment on the Pharmacokinetics of CRV431,” will enroll 24
patients consisting of eight with mild, eight with moderate, and
eight with severe hepatic impairment, based on established
Child-Pugh scores. Up to an additional 24 healthy subjects will
serve as the control group. The objective of the IND opening study
and proposed clinical development program is to characterize the
safety, tolerability and pharmacokinetics of CRV431 monotherapy in
patients with liver disease to establish dose ranges for patients
with differing degrees of NASH.
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.
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; 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 RelationsDirect:
(646) 274-3580skilmer@hepionpharma.com
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