Compelling Positive Results Reported from Human Liver Experiments with ContraVir Pharmaceuticals’ NASH Drug Candidate
17 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 its first study with human precision cut
liver slice cultures. Liver disease was simulated in this unique
experimental model by application of the potent, profibrotic
molecules, TGFβ and PDGF. Co-administration of ContraVir’s clinical
phase drug candidate, CRV431, was found to be 100% effective at
preventing fibrosis induction beyond baseline levels. CRV431 at
clinically relevant concentrations also partially or completely
blocked several genetic and protein biomarkers of inflammation
(e.g. IL-6, MCP-1) and fibrosis (e.g. collagen, fibronectin,
hyaluronic acid, TIMP-1).
In this experiment, CRV431 was more effective at
preventing fibrosis than elafibranor, a dual PPAR α/δ agonist, and
obeticholic acid (OCA), an FXR agonist, both Phase 3 NASH drug
candidates which were tested simultaneously with CRV431.
Elafibranor was 62% effective and OCA was 9% effective at
preventing fibrosis, which was measured by Picrosirius Red
staining. The beneficial effects of CRV431 on biomarkers of
inflammation and fibrosis were similar to those of elafibranor and
greater than those of OCA. CRV431 exerted its therapeutic
activities at lower concentrations than the other two late-stage
drugs, suggesting that CRV431 is a highly potent pharmaceutical
agent. At the same time, CRV431 did not demonstrate any negative
effects on liver biomarkers, further supporting the safety profile
of CRV431.
The study was conducted by FibroFind, a spin-out
contract research company from the Fibrosis Research Group at
Newcastle University, Newcastle Upon Tyne UK, that spent two years
optimizing this experimental model, called precision cut liver
slices (“PCLS”). Dr. Jelena Mann, CEO of FibroFind commented,
“Initial findings from this study are extremely encouraging and
demonstrate exciting potential for CRV431 as a treatment for
fibrotic diseases. We anticipate conducting further studies with
CRV431 in this, and other models, to further investigate the
beneficial effects of this molecule in greater detail.”
Dr. Robert Foster, CEO of ContraVir, commented,
“The results from this study are highly meaningful because they
come from fully intact samples of human livers. The closer that
experimental models are to replicating what happens in the human
body, the greater the likelihood that the therapeutic effects
observed in the models will translate to human diseases.” Dr.
Foster further added, “Precision cut liver slices adds to the
growing list of experiments where CRV431 has demonstrated
effectiveness and gives us great confidence in developing CRV431
for NASH and other liver diseases. These recent findings from
FibroFind, taken together with our recent animal models
demonstrating efficacy in NASH and fibrosis bode well for further
advancement in the clinic.”
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
previously showed CRV431 to be safe and well tolerated in humans.
Currently, CRV431 is being administered in a 28-day multiple
ascending dose study.
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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