Conatus Announces Results from ENCORE-LF and ENCORE-PH Phase 2b Clinical Trials in NASH Cirrhosis
June 24 2019 - 4:05PM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced that
top-line results from the company’s ENCORE-LF clinical trial of
emricasan did not meet its primary endpoint and the company is
discontinuing further treatment of patients enrolled in the
ENCORE-LF clinical trial. Also, results from the 24-week
extension in the company’s ENCORE-PH clinical trial of emricasan
were consistent with results from the initial 24-week treatment
period and did not meet predefined objectives. Conatus will
continue to work with its partner Novartis on ensuring that all
remaining obligations related to the emricasan program are
fulfilled.
The randomized, double-blind ENCORE-LF Phase 2b clinical trial,
initiated in the second quarter of 2017, enrolled 217 patients with
decompensated NASH 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 trial was conducted at 73 U.S.
sites. The trial’s primary endpoint was event-free survival, which
was defined as a composite of all-cause mortality, new
decompensation events, or ≥4 points progression in Model for
End-stage Liver Disease (MELD) score. The primary analysis was
conducted after reaching an overall target number of events and
showed no statistically significant differences in event rates
between the treatment and placebo arms and no clear trends
indicating a potential treatment effect.
The randomized, double-blind ENCORE-PH Phase 2b clinical trial,
initiated in the fourth quarter of 2016, enrolled 263 NASH patients
with 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 trial was conducted at 75
U.S. and EU sites. As announced in December 2018, the trial failed
to meet its primary endpoint – change in mean hepatic venous
pressure gradient (HVPG) from baseline to Week 24 in any of three
emricasan dosing groups compared with placebo. Patients enrolled in
the ENCORE-PH clinical trial were allowed to continue treatment or
placebo in a 24-week extension period to evaluate longer term
safety, liver function and clinical outcomes. Results following the
extension period were consistent with Week 24 results, showing no
statistically significant differences between treatment and placebo
arms and no clear trends indicating a potential treatment
effect.
Consistent with safety results from 19 previously completed
clinical trials, emricasan was generally well-tolerated in both the
ENCORE-LF and ENCORE-PH clinical trials.
“We designed the ENCORE program to give emricasan an opportunity
to achieve its potential through a series of clinical trials
tailored to specific patient populations encompassing a broad range
of chronic liver disease,” said Steven J. Mento, Ph.D., President,
Chief Executive Officer and co-founder of Conatus. “We are
disappointed that emricasan failed to meet the expectations
established in prior preclinical and clinical studies, but
confident that the ENCORE trials provided a fair evaluation of
emricasan’s lack of efficacy in these patient populations.”
David T. Hagerty, M.D., Executive Vice President of Clinical
Development at Conatus, said, “We offer sincere thanks to the
patients, principal investigators, collaborators, service providers
and investors who enabled the development of emricasan. We offer
hope that the scientific and clinical communities will build on the
knowledge gained from these efforts in their continued pursuit of
new treatment alternatives for chronic liver disease.”
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 remaining obligations related to the
emricasan program. 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; 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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