ContraVir Pharmaceuticals Sets the Stage for CRV431 Development in NASH with Positive Results from Second Model of Liver Fibr...
06 Giugno 2019 - 2:00PM
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 findings from a preclinical study where CRV431, a novel
cyclophilin inhibitor, significantly decreased the extent of
fibrosis in a second animal model of liver fibrosis. Fibrosis, or
scarring, of the liver is a hallmark symptom of NASH that results
in impaired liver function. Obeticholic acid (“OCA”), a
semi-synthetic bile acid analogue drug approved for the treatment
primary biliary cholangitis (“PBC”) and being evaluated in Phase 3
trials by another company, was used as a comparator drug in the
study and did not decrease the extent of fibrosis in this study
conducted by ContraVir.
In this industry-standard model, liver fibrosis
is induced in mice by administering carbon tetrachloride (“CCl4”).
In the preclinical study, CCl4-treated mice received either 50
mg/kg of CRV431; 10 mg/kg of OCA; or a vehicle control. All were
administered orally, once daily for six weeks. Liver fibrosis was
then quantified using Sirius Red staining to measure the amount of
hepatic collagen, which accumulates in fibrosis. Compared to the
control group, CRV431 reduced fibrosis scores by approximately 43%
(p = 0.005), whereas OCA did not demonstrate a statistically
significant reduction in fibrosis.
“This is the second animal model, and the fifth
study overall, in which CRV431 consistently demonstrated a
statistically significant reduction in fibrosis,” said Dr. Robert
Foster, Chief Executive Officer of ContraVir. “In addition, this
study showed that CRV431 reduced fibrosis where OCA, a drug
approved for PBC with potential to treat additional liver diseases,
such as NASH, did not. Therefore, CRV431’s superior efficacy
profile in this model, is very promising and is especially exciting
given CRV431’s additional anti-viral and anti-cancer properties we
have demonstrated in other preclinical studies. We will continue to
study additional models of fibrosis in preparation for future NASH
clinical trials.”
This trial, conducted at the Scripps Research
Institute, is the fifth to demonstrate statistically significant
anti-fibrotic efficacy of CRV431, but the first to use the CCl4
animal model. Previously, four separate, independent preclinical
studies demonstrated similar effects of CRV431 in a STAM NASH
model. In the STAM NASH model, liver fibrosis is induced in mice by
administering streptozotocin, followed by a high fat diet beginning
at three weeks of age and continuing for the duration of the study.
All four studies showed statistically significant reductions in
fibrosis scores:
- In the first study, conducted at
the Stelic Institute in Japan, STAM NASH mice were administered
CRV431 orally, once daily for three weeks at a dose of 20 mg/kg,
which decreased the extent of fibrosis by 57% compared to vehicle
control (p < 0.01).
- In the second study, conducted at
the Scripps Research Institute, STAM NASH mice were administered
CRV431 orally, once daily for six weeks at a dose of 50 mg/kg,
which decreased the extent of fibrosis by 46% compared to vehicle
control (p = 0.03).
- In the third study, conducted at
the Scripps Research Institute, STAM NASH mice were administered
CRV431 orally, once daily for 11 weeks at a dose of 50 mg/kg, which
decreased the extent of fibrosis by 37% compared to vehicle control
(p = 0.01).
- In the fourth study, conducted at
the Scripps Research Institute, STAM NASH mice were administered
CRV431 orally, once daily for 10 weeks at a dose of 50 mg/kg but at
a much later stage of disease. In this study, fibrosis was reduced
by 44%, confirming CRV431 efficacy across a wide range of disease
time points (p=0.014).
ContraVir is developing CRV431 for NASH,
fibrosis and other liver diseases such as viral hepatitis and
hepatocellular carcinoma. A Phase 1, single ascending dose study of
CRV431 was safe and well tolerated in humans.
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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