Conatus Pharmaceuticals Announces Publication Demonstrating that Emricasan Ameliorates Portal Hypertension, Improves Liver St...
30 Abril 2019 - 8:30AM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced a new
publication1 in Hepatology Communications detailing results
following seven-day treatment with emricasan, the company’s
first-in-class pan-caspase inhibitor, in rats with advanced
cirrhosis including increased portal pressure induced by chronic
carbon tetrachloride administration. Portal pressure was
significantly reduced in emricasan-treated rats relative to
vehicle-treated control animals. Reduced portal pressure was
associated with significantly better liver function, reduced liver
inflammation, and reduced fibrosis. Improvements in expression of
markers of liver function, including increased expression of
vasodilators and reduced expression of vasoconstrictors, were
observed in liver cells isolated from emricasan-treated cirrhotic
rats. In vitro experiments treating human cirrhotic liver cells
with emricasan improved the synthetic capacity of hepatocytes from
cirrhotic livers and increased expression of specific markers of
liver function.
The publication’s authors concluded that, “This study
demonstrates that emricasan improves liver sinusoidal microvascular
dysfunction in cirrhosis, which leads to marked amelioration in
fibrosis, portal hypertension and liver function, and therefore
encourages its clinical evaluation in the treatment of advanced
chronic liver disease.”
“The current study provides mechanistic support for the results
from clinical studies evaluating emricasan’s ability to reduce
portal hypertension in patients with advanced cirrhosis,” said Al
Spada, Ph.D., Executive Vice President of Research and Development,
Chief Scientific Officer and co-founder of Conatus, and an author
on the publication. “We believe the insights provided by the
cumulative body of preclinical data, coupled with the corresponding
results from human clinical testing, support continued evaluation
in NASH cirrhosis patients.”
Emricasan Clinical DevelopmentThe company is
currently conducting two double-blind, placebo-controlled Phase 2b
clinical trials in collaboration with Novartis – the EmricasaN, a
Caspase inhibitOR, for Evaluation (ENCORE) trials, designed to
evaluate emricasan in patients with liver cirrhosis caused by
nonalcoholic steatohepatitis (NASH).
- The ENCORE-LF (for Liver Function) clinical trial, initiated in
the second quarter of 2017, has enrolled approximately 210 patients
with stable decompensated NASH cirrhosis. The primary endpoint is
event-free survival, which is a composite of all-cause mortality,
new decompensation events, or ≥4 points progression in Model for
End-stage Liver Disease (MELD) score. Enrollment was completed in
the first quarter of 2019. Top-line results triggered by reaching a
prespecified number of events are expected in mid-2019.
- The ENCORE-PH (for Portal Hypertension) clinical trial,
initiated in the fourth quarter of 2016, enrolled 263 patients with
compensated or early decompensated NASH cirrhosis and severe portal
hypertension. The trial’s primary endpoint was change in mean
hepatic venous pressure gradient (HVPG) from baseline to Week 24 in
any of three emricasan dosing groups compared with placebo.
Top-line results were reported in December 2018 showing HVPG trends
consistently favoring emricasan compared with placebo in the
overall population but not meeting the primary endpoint. The
greatest improvement was observed in patients with a baseline HVPG
of 16 mmHg or higher. Patients had the option to continue on their
assigned doses of treatment or placebo in a double-blind 24-week
extension period. Results following the extension period are
expected in mid-2019 and will include longer term safety, liver
function and clinical outcomes, but there will be no additional
HVPG measurements.
About Conatus PharmaceuticalsConatus is a
biotechnology company focused on the development and
commercialization of novel medicines to treat chronic diseases with
significant unmet need. In collaboration with Novartis, Conatus is
developing its lead in-licensed compound, emricasan, for the
treatment of patients with NASH-driven chronic liver diseases.
Conatus is independently developing its lead internally developed
compound, CTS-2090, for the treatment of patients with chronic
diseases involving inflammasome pathways. For additional
information, please visit www.conatuspharma.com.
Forward-Looking Statements This press release
contains forward-looking statements within the meaning of Section
21E of the Securities Exchange Act of 1934, as amended. All
statements other than statements of historical facts contained in
this press release are forward-looking statements, including
statements regarding the timeline for results from the ENCORE
trials. In some cases, you can identify forward-looking statements
by terms such as “may,” “will,” “should,” “expect,” “plan,”
“anticipate,” “could,” “intend,” “target,” “project,”
“contemplates,” “believes,” “estimates,” “predicts,” “potential” or
“continue” or the negative of these terms or other similar
expressions. These forward-looking statements speak only as of the
date of this press release and are subject to a number of risks,
uncertainties and assumptions, including: results of future
clinical trials of emricasan; the uncertainty of the U.S. Food and
Drug Administration’s and other regulatory agencies’ approval
processes and other regulatory requirements; and those risks
described in the company’s prior press releases and in the periodic
reports it files with the Securities and Exchange Commission. The
events and circumstances reflected in the company’s forward-looking
statements may not be achieved or occur and actual results could
differ materially from those projected in the forward-looking
statements. Except as required by applicable law, the company does
not plan to publicly update or revise any forward-looking
statements contained herein, whether as a result of any new
information, future events, changed circumstances or otherwise.
CONTACT: Alan EngbringConatus
Pharmaceuticals Inc.(858) 376-2637aengbring@conatuspharma.com
______________________________
1 Gracia-Sancho J et al. Emricasan Ameliorates
Portal Hypertension and Liver Fibrosis in Cirrhotic Rats Through a
Hepatocyte-Mediated Paracrine Mechanism. Hepatol Comm. 2019. DOI
10.1002/hep4.1360.
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