Conatus Pharmaceuticals Announces Publications Expanding on Previously Reported Results from Completed Phase 2 NAFLD-NASH, Po...
January 28 2019 - 7:30AM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced
publications expanding on previously reported results from three of
the company’s completed Phase 2 clinical trials.
- Mitchell Schiffman, M.D., is the lead author on a new
publication1 in Alimentary Pharmacology and Therapeutics detailing
results from the double-blind, placebo-controlled Phase 2
NAFLD/NASH clinical trial. This trial enrolled 38 patients with
nonalcoholic fatty liver disease (NAFLD), including the subset of
NAFLD patients with nonalcoholic steatohepatitis (NASH). Patients
were randomized 1:1 to receive either 25 mg of emricasan or placebo
orally twice daily for 28 days. Top-line results from the
NAFLD/NASH clinical trial were released in March 2015 and presented
at The International Liver Congress™, the annual meeting of the
European Association for the Study of the Liver (EASL), in April
20152.
- Guadalupe Garcia-Tsao, M.D., is the lead author on a new
publication3 in Hepatology detailing results from the exploratory,
open-label Phase 2 Portal Hypertension clinical trial. This trial
enrolled 23 patients with portal hypertension and compensated liver
cirrhosis that was predominantly due to NASH or hepatitis C virus
(HCV), including patients with active HCV infection and patients
who had a sustained viral response to antiviral therapy. Patients
received 25 mg of emricasan orally twice daily for 28 days.
Top-line results from the Portal Hypertension clinical trial were
released in September 2015 and presented at The Liver Meeting®, the
annual meeting of the American Association for the Study of Liver
Diseases (AASLD) in November 20154.
- Catherine Frenette, M.D., is the lead author on a new
publication5 in Clinical Gastroenterology and Hepatology detailing
results from the Phase 2 Liver Cirrhosis trial. This trial enrolled
86 patients with liver cirrhosis, mild to moderate liver impairment
and a Model for End-stage Liver Disease (MELD) score of 11 to 18
during the screening period. In the first phase of the trial,
patients were randomized 1:1 to receive 25 mg of emricasan or
placebo orally twice daily for 28 days. Top-line results from the
first stage were released in January 2016 and presented at the EASL
annual meeting in April 2016. In the open-label second stage,
patients who completed the first stage of the trial, either on
treatment or placebo, received emricasan for up to an additional
three months. Top-line results from the second stage were released
in May 2016 and presented at the AASLD annual meeting in November
20166.
“The results from this series of Phase 2 clinical trials led to
the design of the three Phase 2b ENCORE clinical trials for NASH
patients with liver fibrosis or cirrhosis,” said David T. Hagerty,
M.D., Executive Vice President of Clinical Development at Conatus.
“We believe the aggregate data from the ENCORE trials will support
discussions regarding the further development of emricasan.”
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-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), for which top-line results
were announced in December 2018, has an ongoing six-month extension
with 48-week liver function and clinical outcome results expected
in mid-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 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. 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: the potential for the aggregate data
from the ENCORE trials to support discussions regarding the further
development of emricasan; the timeline for results from the ENCORE
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: the potential that further analysis of the data
described herein or additional data may yield different results;
results of future clinical trials of emricasan; the potential for
competing products to limit the clinical trial enrollment
opportunities for emricasan in certain indications; the uncertainty
of the U.S. Food and Drug Administration’s and other regulatory
agencies’ approval processes and other regulatory requirements; and
those risks described in the company’s prior press releases and in
the periodic reports it files with the Securities and Exchange
Commission. The events and circumstances reflected in the company’s
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,
the company 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.
1 Schiffman M et al. Randomised clinical trial:
emricasan versus placebo significantly decreases ALT and caspase
activation in subjects with non-alcoholic fatty liver disease.
Aliment Pharmacol Ther. 2019;49:64-73. DOI: 10.1111/apt.15030.
2 Shiffman M et al. A placebo-controlled,
multicenter, double-blind, randomised trial of emricasan (IDN-6556)
in subjects with non-alcoholic fatty liver disease (NAFLD) and
raised transaminases. Poster presented at EASL April 2015. Poster
#LP37.
3 Garcia-Tsao G et al. Emricasan (IDN-6556) Lowers
Portal Pressure in Patients with Compensated Cirrhosis and Severe
Portal Hypertension. Hepatol. 2018. DOI: 10.1002/hep.30199.
4 Garcia-Tsao G et al. Emricasan (IDN-6556)
administered orally for 28 days lowers portal pressure in patients
with compensated cirrhosis and severe portal hypertension.
Late-breaking oral presentation at AASLD November 2015.
Presentation #LB6.
5 Frenette, CT et al. Emricasan Improves Liver
Function in Patients With Cirrhosis and High Model for End-stage
Liver Disease Scores Compared With Placebo. Clin Gastroenterol
Hepatol. 2018. DOI: 10.1016/j.cgh.2018.06.012.
6 Frenette C et al. Emricasan (IDN-6556) orally for
three months in patients with cirrhosis and MELD scores 11-18
improves clinical parameters of cirrhosis in patients with baseline
MELD score ≥15. Late breaker oral presentation at EASL April 2016.
Presentation #LBO5.
CONTACT: Alan EngbringConatus Pharmaceuticals
Inc.(858) 376-2637aengbring@conatuspharma.com
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