Conatus Pharmaceuticals and BioReliance Present Key Emricasan Preclinical Safety Results at Society of Toxicology Annual Meet...
March 23 2015 - 4:01PM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) and its research
collaborator BioReliance, Sigma-Aldrich Corporation's (Nasdaq:SIAL)
biologics and early-development services business, are presenting a
poster today at the 54th Annual Meeting of the Society of
Toxicology (San Diego – March 22-26, 2015). The poster, entitled
"Carcinogenicity Assessment of the Pan-Caspase Inhibitor,
Emricasan, in Tg.rasH2 Mice," will be available for viewing in the
Exhibit Hall of the San Diego Convention Center today, Monday,
March 23, 2015, from 1:00 p.m. to 4:30 p.m. PT,and the authors will
be available for discussion at the poster from 1:00 p.m. to 2:45
p.m. PT. The poster is available on the Events & Presentations
page in the Investor Center of the Conatus website at
www.conatuspharma.com.
The poster describes previously announced results of a rigorous
six-month evaluation of emricasan, Conatus' orally active,
irreversible pan-caspase protease inhibitor, in the Tg.rasH2
humanized mouse model, which is highly prone to developing cancer.
Tg.rasH2 mice were fed 0, 10, 25, and 75 mg/kg/day of emricasan for
26 weeks. There were no treatment related deaths or overt signs of
toxicity for the duration of the study. There was no evidence of
emricasan-related tumor formation in any tissue. The primary
conclusion of the study, which was completed in 2012, was that
emricasan did not increase the incidence of neoplastic lesions in
Tg.rasH2 mice and is thus considered to have no carcinogenic
potential in human.
"Because of emricasan's potent ability to reduce excessive
apoptosis and inflammation, we wanted to address historical,
theoretical concerns about cancer with a conclusive carcinogenicity
study to supplement our extensive safety database in humans," said
Conatus co-founder, Executive Vice President of Research and Chief
Scientific Officer, Alfred P. Spada, Ph.D. "We are very pleased to
report results from this important study, which generated solidly
positive data that directly and successfully addressed the
theoretical concern regarding the carcinogenic potential of
emricasan."
About Emricasan Clinical Development
To date, emricasan has been studied in more than 550 subjects in
thirteen clinical trials. In a completed Phase 2b clinical trial,
emricasan consistently demonstrated statistically significant,
rapid and sustained reductions in elevated levels of key biomarkers
of inflammation and apoptosis that are implicated in the severity
and progression of liver disease. Importantly, these key biomarkers
are known to be elevated and to have prognostic value in multiple
hepatic indications that Conatus is currently pursuing. Conatus is
developing emricasan for the treatment of patients with chronic
liver disease, including four ongoing Phase 2 clinical trials in
these various liver disease patient populations:
- patients with nonalcoholic fatty liver disease (NAFLD),
including the subset of NAFLD patients with inflammatory and/or
fibrotic nonalcoholic steatohepatitis (NASH), for which top-line
results are expected in the first quarter of 2015;
- post-orthotopic liver transplant (POLT) recipients with liver
fibrosis post-transplant as a result of recurrent hepatitis C virus
(HCV) infection who have successfully achieved a sustained viral
response (SVR) following HCV antiviral therapy (POLT-HCV-SVR), for
which initial baseline data are expected in the second quarter of
2015;
- patients with liver cirrhosis (LC) and portal hypertension
(PH), for which top-line results are expected in the third quarter
of 2015; and
- patients with LC and Model for End-stage Liver Disease (MELD)
scores of 11 to 18, for which initial results are expected in the
fourth quarter of 2015.
These ongoing clinical trials are expected to confirm and refine
the most appropriate initial registration pathway, subject to
regulatory agency discussions.
About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development
and commercialization of novel medicines to treat liver disease.
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 protease inhibitor
designed to reduce the activity of enzymes that mediate
inflammation and apoptosis. Conatus believes that by reducing the
activity of these enzymes, emricasan has the potential to interrupt
the disease progression across the spectrum of 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 timeline to
announce top-line results from the Phase 2 NAFLD/NASH clinical
trial; the timeline to announce initial baseline data from the
POLT-HCV-SVR Phase 2b clinical trial; the timeline to announce
top-line results from the Phase 2 PH clinical trial; the timeline
to announce initial results from the Phase 2 LC clinical trial; the
ability to confirm and refine the most appropriate initial
registration pathway, subject to regulatory agency discussions,
based on the company's ongoing clinical trials; and emricasan's
therapeutic potential in patients with liver disease. 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: Conatus' ability to initiate and
successfully complete current and future clinical
trials; Conatus' dependence on its ability to obtain
regulatory approval for, and then successfully commercialize
emricasan, which is Conatus' only drug candidate; Conatus' reliance
on third parties to conduct its clinical trials, enroll subjects,
manufacture its preclinical and clinical drug supplies and
manufacture commercial supplies of emricasan, if approved; the
potential that earlier studies may not be predictive of future
results; potential adverse side effects or other safety risks
associated with emricasan that could delay or preclude its
approval; Conatus' ability to obtain orphan drug exclusivity for
emricasan for any indication; 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; Conatus' ability to fully comply
with numerous federal, state and local laws and regulatory
requirements applicable to it; Conatus' limited operating history
and its ability to operate successfully as a public company;
Conatus' ability to obtain additional financing in order to
complete the development and commercialization 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: MEDIA: David Schull
Russo Partners, LLC
(858) 717-2310
David.Schull@RussoPartnersLLC.com
INVESTORS: Alan Engbring
Conatus Pharmaceuticals Inc.
(858) 376-2637
aengbring@conatuspharma.com
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