EMA Grants Conatus Orphan Drug Designation for IDN-7314 for the Treatment of PSC
October 18 2017 - 4:05PM
Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) today announced that the
European Medicines Agency (EMA) has granted orphan designation to
Conatus’ drug candidate IDN-7314 for the treatment of primary
sclerosing cholangitis (PSC), a disease affecting bile ducts in the
liver which can lead to cirrhosis and liver failure. The EMA's
orphan designation program is intended to encourage the development
of medicines that may provide benefit to patients suffering from
rare life-threatening or chronically debilitating conditions.
IDN-7314 was granted Orphan Drug Designation for the treatment of
PSC by the U.S. Food and Drug Administration in June 2017.
IDN-7314 is an orally active pan-caspase protease inhibitor
designed to reduce the activity of enzymes that mediate
inflammation and cell death (or apoptosis), which has demonstrated
reduction of relevant biomarkers in two preclinical models of PSC.
One nonclinical model, the Mdr2-/- (knockout) mouse model is
considered the current benchmark nonclinical model of PSC. A new
preclinical model, second mitochondria-derived activator of
caspases (SMAC)-mimetic induced PSC in mice, has recently been
reported that reproduces much of the phenotype of human PSC.
IDN-7314 significantly improved biochemical indices of hepatic and
biliary damage in these murine models of PSC, and these results
suggest the involvement of caspases in the progression of PSC.
“As we advance in the evaluation of opportunities to expand our
pipeline beyond emricasan, adding orphan designation in Europe to
the recent orphan drug designation in the United States enhances
the potential attractiveness of developing IDN-7314 for the
treatment of PSC,” said Conatus Co-Founder, President and Chief
Executive Officer, Steven J. Mento, Ph.D. “We continue to evaluate
a number of potential internal and external opportunities with a
goal of announcing our initial pipeline expansion plans later in
2017.”
About EMA Orphan Drug DesignationThe EMA orphan
drug designation is granted only to medicines being developed for
the diagnosis, prevention or treatment of a life-threatening or
chronically debilitating condition with a prevalence in the
European Union (EU) not more than five in 10,000. EMA orphan drug
designation benefits include protocol assistance, access to the EU
centralized authorization procedure, reduced EU regulatory filing
fees and ten years of market exclusivity. Conatus would be eligible
for additional incentives available to small and medium-sized
enterprises (SMEs), including administrative and procedural
assistance with the European regulatory process.
About Conatus PharmaceuticalsConatus is a
biotechnology company focused on the development and
commercialization 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: IDN-7314 as a potential treatment for
PSC; plans to announce pipeline development opportunities in 2017;
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 risk that the preclinical results may not be
predictive of future clinical results; Conatus’ ability to utilize
the EMA orphan designation; 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
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