Conatus Announces Completion of Enrollment in ENCORE-NF Phase 2b Clinical Trial of Emricasan in Patients with NASH Fibrosis
August 14 2017 - 4:05PM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced the
completion of enrollment in ENCORE-NF, a randomized, double-blind,
placebo-controlled, Phase 2b clinical trial evaluating emricasan,
the company’s first-in-class, orally-active pan-caspase inhibitor,
in approximately 330 patients with biopsy-confirmed nonalcoholic
steatohepatitis (NASH) and stage 1 to 3 fibrosis using the NASH
Clinical Research Network (CRN) Histologic Scoring System. This
trial is designed to evaluate the long-term safety and efficacy of
emricasan in patients with NASH fibrosis as well as support the
initial registration focus in liver cirrhosis.
“We are pleased to have completed enrollment in the ENCORE-NF
clinical trial in this highly competitive NASH fibrosis field,”
said David T. Hagerty, M.D., Executive Vice President of Clinical
Development at Conatus. “We would like to thank the patients and
the investigators who are participating in the trial, and all the
study teams who helped us reach this important milestone.
Emricasan’s ability to improve both liver fibrosis and liver
inflammation has been demonstrated in preclinical models of NASH,
and we look forward to helping advance this novel product candidate
to address the substantial unmet medical needs of NASH fibrosis
patients.”
The ENCORE-NF clinical trial is being conducted at approximately
100 U.S. and EU clinical sites. Patients were randomized 1:1:1 to
receive 5 mg of emricasan, 50 mg of emricasan, or placebo twice
daily for 72 weeks. The primary endpoint is a biopsy-based
improvement in fibrosis by at least one stage vs. placebo using
NASH CRN without worsening of steatohepatitis. Secondary endpoints
include resolution of steatohepatitis without worsening of
fibrosis, nonalcoholic fatty liver disease (NAFLD) activity score
(NAS) and its components (steatosis, lobular inflammation, and
ballooning), collagen and fat content by biopsy, key serum
biomarkers, and health-related quality of life, as well as safety
and tolerability.
Emricasan Clinical Development
In collaboration with Novartis, Conatus is conducting four
randomized, double-blind, placebo-controlled Phase 2b clinical
trials designed to evaluate emricasan treatment in various patient
populations, including three in the EmricasaN, a Caspase inhibitOR,
for Evaluation (ENCORE) series in patients with fibrosis or
cirrhosis caused by NASH, and a fourth in POLT-HCV-SVR
patients:
- 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;
- ENCORE-PH (for Portal Hypertension), initiated in the fourth
quarter of 2016, in approximately 240 patients with compensated or
early decompensated NASH cirrhosis and severe portal hypertension,
with top-line results expected in 2018 followed by an integrated
6-month treatment extension period for clinical
outcomes;
- 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 2019; and
- POLT-HCV-SVR, initiated in the second quarter of 2014, in
approximately 60 post-orthotopic liver transplant (POLT) recipients
with liver fibrosis or cirrhosis post-transplant as a result of
recurrent HCV infection who have successfully achieved a sustained
viral response (SVR) following HCV antiviral therapy, with top-line
results expected in the first half of 2018.
Results from the four ongoing emricasan clinical trials are
expected to support the design of Phase 3 clinical efficacy and
safety trials.
About Conatus PharmaceuticalsConatus is a
biotechnology company focused on the development and
commercialization 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 details of and the timelines to
announce results from the ENCORE-LF, ENCORE-NF, ENCORE-PH and
POLT-HCV-SVR clinical trials; the ability of results from ongoing
trials to support the design of Phase 3 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 Engbring
Conatus Pharmaceuticals Inc.
(858) 376-2637
aengbring@conatuspharma.com
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