Conatus Announces Top-line Results from ENCORE-NF Phase 2b Clinical Trial in NASH Fibrosis
March 21 2019 - 3:05PM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced top-line
results from the company’s Phase 2b ENCORE-NF clinical trial in
patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH)
and liver fibrosis. The trial’s primary endpoint was a ≥1 CRN
fibrosis stage improvement with no worsening of steatohepatitis
compared with placebo at week 72.
“Although emricasan did not have the desired effect in these
earlier-stage NASH fibrosis patients, we believe its demonstrated
biomarker activity across a broad spectrum of liver disease
warrants continued evaluation in more advanced-stage NASH cirrhosis
patients,” said Steven J. Mento, Ph.D., President, Chief Executive
Officer and co-founder of Conatus. “We look forward to seeing the
additional data readouts expected over the coming months and
reviewing the totality of these results with our collaborators at
Novartis to determine the most appropriate path forward.”
Consistent with safety results from 18 previously completed
clinical trials, emricasan was generally well-tolerated in the
ENCORE-NF clinical trial.
David T. Hagerty, M.D., Executive Vice President of Clinical
Development at Conatus, said, “We are most grateful to the NASH
fibrosis patients, principal investigators, clinical site staffs
and the support teams who participated in the ENCORE-NF clinical
trial.”
About EmricasanEmricasan 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. To date, emricasan has been studied in more
than 950 patients in 19 completed clinical trials across a broad
range of liver diseases. In NASH cirrhosis patients in multiple
Phase 2 clinical trials, emricasan has demonstrated clinically
meaningful reductions in severe portal hypertension, improvements
in measures of liver function, and evidence of an anti-fibrotic
treatment effect, as well as rapid and sustained reductions in
elevated levels of key biomarkers of inflammation and cell death,
which play a role in the severity and progression of liver
disease.
About ENCORE-NFThe randomized, double-blind
ENCORE-NF Phase 2b clinical trial, initiated in the first quarter
of 2016, enrolled and treated 318 patients with biopsy-confirmed
NASH CRN fibrosis stages F1-F3 at baseline. Patients were
randomized 1:1:1 to receive 5 mg of emricasan, 50 mg of emricasan,
or placebo twice daily for 72 weeks. The trial was conducted at 87
U.S. and EU sites.
About Emricasan Clinical DevelopmentENCORE-NF
is one of three randomized, double-blind, placebo-controlled Phase
2b clinical trials conducted by Conatus in collaboration with
Novartis, 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) in approximately 210 patients
with decompensated NASH cirrhosis, initiated in the second quarter
of 2017, is advancing toward an event-driven analysis of clinical
outcome results expected in mid-2019.
- ENCORE-PH (for Portal Hypertension) in 263 patients with NASH
cirrhosis and severe portal hypertension, initiated in the fourth
quarter of 2016, with top-line results after 24 weeks of treatment
announced in the fourth quarter of 2018, is completing a six-month
extension with liver function and clinical outcome results after 48
weeks of treatment expected in mid-2019.
Conatus and Novartis expect to evaluate the totality of data
available from the ENCORE trials to determine the potential for
further development of emricasan. 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: a path forward for emricasan; and the
timelines to announce results from the ENCORE clinical
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: reported
top-line results are based on preliminary analysis of key data and
as a result, such top-line results may change following a more
comprehensive review and may not accurately reflect the complete
results of the clinical trial; Conatus’ ability to successfully
enroll patients in and complete its ongoing clinical trials;
Novartis continuing development and commercialization of emricasan;
the uncertainties inherent in the clinical drug development
process, including, the potential for additional negative or
confounding results for emricasan; Conatus’ reliance on third
parties to conduct its clinical trials, including the enrollment of
patients, and manufacture its clinical drug supplies of emricasan;
potential adverse side effects or other safety risks associated
with emricasan that could delay or preclude its approval; results
of future clinical trials of emricasan; and 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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