ContraVir Pharmaceuticals Submits IND Application for CRV431 for NASH
27 Junho 2019 - 9:00AM
ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), 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 the filing of an Investigational New Drug (“IND”)
application with the U.S. Food and Drug Administration (“FDA”) for
CRV431 for the treatment of NASH.
ContraVir’s proposed IND opening study is
entitled, “An Open-Label Study to Investigate the Effect of Hepatic
Impairment on the Pharmacokinetics of CRV431.” The study will
enroll 24 patients, consisting of eight with mild, eight with
moderate, and eight with severe hepatic impairment, based on
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
role of CRV431 monotherapy as anti-fibrotic treatment in NASH
patients.
“Our team has worked diligently to assemble this
IND submission,” commented Dr. Robert Foster, ContraVir’s CEO. “We
hope to receive confirmation that our submission has been accepted
by the FDA, Center for Drug Evaluation and Research, in due course.
This submission follows our compelling and positive preclinical and
clinical work conducted to date, indicating that CRV431 offers a
novel approach to treating NASH, with broader applications in liver
disease.”
This application, number IND142904, follows an
earlier IND that was approved for the hepatitis B virus (“HBV”)
indication. Under the previous IND for HBV, ContraVir has completed
a phase 1 single ascending dose study in healthy human subjects,
demonstrating good safety and tolerability and defining the
pharmacokinetics of CRV431. A second clinical study of CRV431
examined the pharmacokinetics of CRV431 when co-administered with
tenofovir disoproxil fumarate (“TDF”). The Company expects to
initiate a third clinical study of CRV431, in the near future, to
determine safety, tolerability, and pharmacokinetics after
repeated, escalating oral dosing in HBV patients over a period of
28 days.
About ContraVir Pharmaceuticals
ContraVir 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. For more information, please
visit www.contravir.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 ContraVir’s 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. ContraVir does not undertake an obligation
to update or revise any forward-looking statement. Investors should
read the risk factors set forth in ContraVir’s 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 KilmerContraVir Investor Relations(646)
274-3580skilmer@contravir.com
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