Conatus Announces Completion of Enrollment in ENCORE-PH Phase 2b Clinical Trial of Emricasan in Patients with NASH Cirrhosis ...
May 02 2018 - 9:36AM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced the
completion of enrollment in ENCORE-PH, a Phase 2b clinical trial
evaluating emricasan, the company’s first-in-class, orally-active
pan-caspase inhibitor. Top-line results from the ENCORE-PH clinical
trial are expected in the fourth quarter of 2018.
“We were pleased to complete enrollment in the ENCORE-PH
clinical trial on schedule,” said David T. Hagerty, M.D., Executive
Vice President of Clinical Development at Conatus. “We thank the
patients for participating in the trial, the clinical investigators
and sites that met our stringent HVPG qualification criteria for
conducting the trial, and the site monitoring teams for
facilitating this timely achievement. We look forward to the
upcoming series of emricasan clinical trial readouts and the
potential opportunity to advance this novel product candidate
toward addressing the unmet medical needs of NASH fibrosis and
cirrhosis patients.”
The ENCORE-PH clinical trial is designed to evaluate safety,
dosing and efficacy of emricasan in NASH cirrhosis as an integral
part of the company’s initial registration strategy. The
double-blind, placebo-controlled trial is being conducted at
approximately 70 U.S. and EU clinical sites in approximately 240
patients with nonalcoholic steatohepatitis (NASH) who have
compensated or early decompensated liver cirrhosis and severe
portal hypertension confirmed by hepatic venous pressure gradient
(HVPG) of ≥12 mmHg at baseline. Patients were randomized 1:1:1:1 to
receive 5 mg of emricasan, 25 mg of emricasan, 50 mg of emricasan,
or placebo twice daily for 24 weeks. The primary endpoint is the
mean change in HVPG from baseline to Week 24. Patients will
continue to be followed for clinical outcomes in a six-month
treatment extension period.
Emricasan Clinical DevelopmentIn collaboration
with Novartis, Conatus is conducting three randomized,
double-blind, placebo-controlled Phase 2b clinical trials, the
EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) trials,
designed to evaluate emricasan in patients with fibrosis or
cirrhosis caused by NASH:
- ENCORE-PH (for Portal Hypertension), initiated in the fourth
quarter of 2016, with top-line results expected in the fourth
quarter of 2018, as described above;
- ENCORE-NF (for NASH Fibrosis), initiated in the first quarter
of 2016, in approximately 330 patients with NASH fibrosis, with
top-line results expected in the first half of 2019; and
- ENCORE-LF (for Liver Function), initiated in the second quarter
of 2017, in approximately 210 patients with decompensated NASH
cirrhosis, with top-line results expected in the second half of
2019.
About Conatus PharmaceuticalsConatus is a
biotechnology company focused on the development of novel medicines
to treat liver disease. In collaboration with Novartis, Conatus is
developing its lead compound, emricasan, for the treatment of
patients with chronic liver disease. Emricasan is a first-in-class,
orally active pan-caspase inhibitor designed to reduce the activity
of enzymes that mediate inflammation and apoptosis. Conatus
believes that by reducing the activity of these enzymes, caspase
inhibitors have the potential to interrupt the progression of a
variety of diseases. For additional information, please visit
www.conatuspharma.com.
Forward-Looking StatementsThis 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 advancement of emricasan to address
unmet medical needs of NASH fibrosis and cirrhosis patients; the
details of and the timelines to announce results from the
ENCORE-PH, ENCORE-NF and ENCORE-LF clinical trials; and caspase
inhibitors' potential to interrupt the progression of a variety of
diseases. 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 those risks
described in Conatus’ prior press releases and in the periodic
reports it files with the Securities and Exchange
Commission. The events and circumstances reflected in Conatus’
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,
Conatus 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
Conatus Pharmaceuticals (NASDAQ:CNAT)
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