ContraVir Pharmaceuticals Receives Positive FDA Response to CRV431 Pre-IND Package for NASH
June 20 2019 - 3:30PM
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 positive feedback from the U.S. Food and Drug
Administration (“FDA”) in response to ContraVir’s
pre-Investigational New Drug (“pre-IND”) meeting with respect to
the development of CRV431 in NASH.
The FDA provided positive feedback on
ContraVir’s existing preclinical data of CRV431 and supports the
study design for the NASH IND opening study. The FDA also concurred
with the company’s proposed plan for further preclinical studies to
support the development of CRV431. Overall, the FDA supported
ContraVir’s clinical development plans for CRV431 in the NASH
indication.
“We are pleased with the FDA’s positive feedback
on the preclinical work we’ve completed to-date, as well their
feedback on additional planned studies that will support an IND
submission for CRV431 in NASH. This IND submission for NASH will be
in addition to our current existing IND for hepatitis B virus
treatment,” said Dr. Robert Foster, Chief Executive Officer of
ContraVir. “We have generated compelling and consistent
anti-fibrotic data from five separate studies in two different
animal models and believe CRV431 holds great promise for this
indication. More recently, we also demonstrated positive activity
in precision cut human liver slices. Liver fibrosis is a very
harmful feature of NASH, and the anti-fibrotic mechanism of CRV431
differentiates it from most drugs in development for NASH. We
intend to continue our thorough examination of additional models,
both in vitro and in vivo, to support our push to phase 2 clinical
trials.”
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, the design, progress and timing of preclinical and
clinical studies, 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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