Conatus Announces Completion of Enrollment in ENCORE-LF Phase 2b Clinical Trial of Emricasan in Patients with Decompensated N...
February 12 2019 - 7:30AM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced the
completion of enrollment in ENCORE-LF, a Phase 2b clinical trial
evaluating emricasan, the company’s first-in-class, orally-active
pan-caspase inhibitor.
“With screening in the ENCORE-LF clinical trial complete, we
remain on track for clinical events as announced last quarter, with
top-line results expected in mid-2019,” said David T. Hagerty,
M.D., Executive Vice President of Clinical Development at Conatus.
“We sincerely appreciate the participation of these advanced liver
disease patients and their contributions to the development of
emricasan to address a serious and largely unmet medical need.”
The ENCORE-LF clinical trial is designed to evaluate safety,
dosing and efficacy of emricasan in patients with decompensated
NASH cirrhosis as an integral part of the company’s initial
registration strategy. The double-blind, placebo-controlled, trial
is being conducted at approximately 90 U.S. clinical sites in
approximately 210 patients with nonalcoholic steatohepatitis (NASH)
who have stable decompensated liver cirrhosis. Patients were
randomized 1:1:1 to receive 5 mg of emricasan, 25 mg of emricasan,
or placebo twice daily for at least 48 weeks. The primary endpoint
is event-free survival, which is a composite of all-cause
mortality, new decompensation events, or Model for End-stage Liver
Disease (MELD) score progression ≥4 points. Analysis of the primary
endpoint will be triggered upon reaching a prespecified target
number of events. An additional analysis is planned after all
patients have completed at least 48 weeks of dosing.
Emricasan Clinical Development
In 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-LF (for Liver Function) with top-line results expected
in mid-2019 as described above;
- ENCORE-NF (for NASH Fibrosis) with top-line results after 72
weeks of treatment for approximately 330 patients with NASH
fibrosis expected in the first half of 2019; and
- ENCORE-PH (for Portal Hypertension) with top-line results after
24 weeks of treatment for 263 patients with NASH cirrhosis and
severe portal hypertension announced in the fourth quarter of 2018,
and results after 48 weeks of treatment for patients opting to
continue expected in mid-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 details of and the timelines to
announce results from the ENCORE-LF, ENCORE-NF and ENCORE-PH
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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