Enanta Pharmaceuticals Announces Data Presentations at the 2018 NASH-TAG Conference
December 21 2017 - 6:30AM
Business Wire
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a chemistry-driven
biotechnology company dedicated to creating and developing small
molecule drugs for viral infections and liver diseases, today
announced that two presentations on EDP-305, Enanta’s FXR agonist
for non-alcoholic steatohepatitis (NASH) and primary biliary
cholangitis (PBC), will be presented at the NASH-TAG conference
January 4-6, 2018 in Park City, Utah.
Data will be presented from Enanta’s Phase 1 study of EDP-305 in
healthy subjects and in subjects with presumptive non-alcoholic
fatty liver disease (NAFLD). Top line results were first announced
on October 23, 2017, and data from this trial studying the safety,
pharmacokinetic, and pharmacodynamic properties of EDP-305 support
further clinical evaluation of EDP-305 in NASH and PBC
patients.
Also, new preclinical data to be presented will demonstrate that
treatment with EDP-305 had a significant therapeutic effect on NASH
progression in NASH mouse models, and resulted in decreased liver
steatosis, hepatocyte ballooning, and total non-alcoholic fatty
liver disease score (NAS).
The following data will be presented during the conference:
Poster Presentation:
- Pharmacokinetics (PK),
pharmacodynamics (PD), and safety/tolerability effects of EDP-305,
a novel, once-daily, oral farnesoid X receptor (FXR) agonist in
healthy subjects and in subjects with presumptive nonalcoholic
fatty liver disease (NAFLD) Alaa Ahmad, Kristen Sanderson,
Daniel Dickerson, Nathalie Adda, Enanta Pharmaceuticals, Inc.,
Watertown, MA USA
Oral Presentation:
- EDP-305, a highly selective and
potent farnesoid X receptor (FXR) agonist, reduces liver steatosis,
ballooning, and non-alcoholic fatty liver disease activity score
(NAS) in two murine models of non-alcoholic steatohepatitis
(NASH) Li-Juan Jiang, Mary Chau, Yang Li and Yat Sun Or, Enanta
Pharmaceuticals, Inc., Watertown, MA, USA
For more information, visit https://www.nash-tag.org/.
About Enanta’s EDP-305 Development ProgramEnanta is
developing EDP-305, its lead farnesoid X receptor agonist, for the
treatment of patients with non-alcoholic steatohepatitis (NASH) and
for patients with primary biliary cholangitis (PBC). Data from a
Phase 1 clinical study demonstrated that EDP-305 was generally safe
and well tolerated over a broad range of single and multiple doses,
with pharmacokinetic (PK) data supporting once daily oral dosing.
Results also support the ability to administer EDP-305 in future
trials at doses that neither elicit clinically significant changes
in lipids nor result in pruritus. EDP-305 has been granted Fast
Track Designation by U.S. Food and Drug Administration for the
treatment of patients with PBC and for NASH patients with liver
fibrosis. Enanta plans to initiate a Phase 2 dose-ranging study in
PBC patients by the end of 2017 and a Phase 2 dose-ranging study in
NASH patients in early 2018.
About EDP-305, a Farnesoid X Receptor (FXR)
AgonistEDP-305 is a potent FXR agonist and Enanta’s lead
product candidate being developed for the treatment of NASH and
PBC. EDP-305 represents a new class of FXR agonists that has been
designed to take advantage of increased binding interactions with
the receptor. Further, this non-bile acid class contains steroidal
and non-steroidal components, and does not contain the carboxylic
acid group that can lead to the formation of taurine and glycine
conjugates normally associated with bile acids, which may also be
present in other classes of FXR agonists.
About NAFLD, NASH, and FXRNon-alcoholic fatty liver
disease (NAFLD) is the accumulation of excessive fat in the form of
triglycerides in patients’ liver cells (steatosis) that is not
caused by alcohol. NAFLD is widely considered to be the liver
expression of metabolic disease associated with type 2 diabetes,
insulin resistance, obesity, and hyperlipidemia. A subgroup of
NAFLD patients has liver cell injury and inflammation in addition
to excessive fat (steatohepatitis). Progression of this condition
leads to non-alcoholic steatohepatitis (NASH). Patients with NASH
can develop fibrosis and ultimately cirrhosis of the liver,
potentially leading to hepatocellular carcinoma (HCC) or requiring
a liver transplant. Farnesoid X receptor (FXR) is a nuclear
receptor and a main regulator of bile acid levels in the liver and
small intestine. It responds to bile acids by regulating gene
transcription of key enzymes and transporters, many of which play
important roles in lipid metabolism, insulin resistance,
inflammation, and fibrosis.
About EnantaEnanta Pharmaceuticals has used its robust,
chemistry-driven approach and drug discovery capabilities to become
a leader in the discovery of small molecule drugs for the treatment
of viral infections and liver diseases. Two protease inhibitors,
paritaprevir and glecaprevir, discovered and developed through
Enanta’s collaboration with AbbVie, have now been approved in
jurisdictions around the world as part of AbbVie’s direct-acting
antiviral (DAA) regimens for the treatment of hepatitis C virus
(HCV) infection, including the marketed regimens MAVYRET™(U.S.)
/MAVIRET™ (ex-U.S.) (glecaprevir/pibrentasvir) and VIEKIRA PAK®
(U.S.) (paritaprevir/ritonavir/ombitasvir/dasabuvir). Royalties and
milestone payments from the AbbVie collaboration are helping to
fund Enanta’s research and development efforts, which are currently
focused on the following disease targets: non-alcoholic
steatohepatitis (NASH)/ primary biliary cholangitis (PBC),
respiratory syncytial virus (RSV) and hepatitis B virus (HBV).
Please visit www.enanta.com for more information.
FORWARD LOOKING STATEMENTSThis press release contains
forward-looking statements, including statements with respect to
the prospects for the development of EDP-305 for the treatment of
NASH and/or PBC. Statements that are not historical facts are based
on management’s current expectations, estimates, forecasts and
projections about Enanta’s business and the industry in which it
operates and management’s beliefs and assumptions. The statements
contained in this release are not guarantees of future performance
and involve certain risks, uncertainties and assumptions, which are
difficult to predict. Therefore, actual outcomes and results may
differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual
results include: the discovery and development risks of early stage
development efforts in disease areas such as NASH that currently
have no therapeutic treatment; potential competition from the
development efforts of others in NASH and PBC; Enanta’s level of
clinical development experience; Enanta’s need to attract and
retain senior management and key scientific personnel; Enanta’s
need to obtain and maintain patent protection for its product
candidates and avoid potential infringement of the intellectual
property rights of others; and other risk factors described or
referred to in “Risk Factors” in Enanta’s most recent Form 10-K for
the fiscal year ended September 30, 2017 and any other periodic
reports filed more recently with the Securities and Exchange
Commission. Enanta cautions investors not to place undue reliance
on the forward-looking statements contained in this release. These
statements speak only as of the date of this release, and Enanta
undertakes no obligation to update or revise these statements,
except as may be required by law.
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version on businesswire.com: http://www.businesswire.com/news/home/20171221005060/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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