[October 20, 2017] |
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Enanta Pharmaceuticals to Present New Preclinical Data on EDP-305, an FXR Agonist for NASH and PBC, at The Liver Meeting® 2017
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
new data presentations on EDP-305, Enanta's lead Farnesoid X receptor
(FXR) agonist being developed for non-alcoholic steatohepatitis (NASH)
and primary biliary cholangitis (PBC), will be presented at The Liver
Meeting® 2017, the Annual Meeting of the American Association for the
Study of Liver Diseases (AASLD), taking place October 20-24, 2017 in
Washington, D.C.
EDP-305 has demonstrated potency and efficacy in a variety of NASH,
fibrosis and cirrhosis animal models. EDP-305 has completed a Phase 1
clinical study in healthy subjects and in subjects with presumed
non-alcoholic fatty liver disease (obese, with or without pre-diabetes
or type 2 diabetes mellitus). Further studies are planned in NASH and
PBC patients.
EDP-305 is a potent agonist of FXR, a nuclear receptor that is the main
regulator of bile acid levels in the liver and small intestine. FXR
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.
The following will be presented during The Liver Meeting® 2017:
Friday, October 20 Presidential Poster of Distinction, 8:00
am - 5:30 pm ET Session: Basic Fibrosis Research and Stellate Cell
Biology #367 - "A novel FXR agonist EDP-305 potently suppresses
hepatic stellate cell activation and hepatic fibrosis in chronic mouse
models of biliary and metabolic liver disease"
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Data demonstrates that EDP-305 directly inhibits hepatic stellate cell
proliferation in vitro and improved pre-established liver
injury and hepatic fibrosis in biliary and metabolic models of liver
disease in mice.
Monday, October 23 Oral Presentation, 8:00 - 9:30 am ET Parallel
Session 23: Steatosis and Steatohepatitis: Experimental I #162-
"Significant anti-fibrotic efficacy of EDP-305, a highly potent and
selective farnesoid X receptor (FXR) agonist, in a rat model of
thioacetamide-induced liver fibrosis and cirrhosis"
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EDP-305 exhibits excellent anti-fibrotic efficacy in rats with ongoing
TAA-induced fibrosis.
Monday, October 23 Presidential Poster of Distinction, 8:00
am - 5:30 pm ET Session: Steatohepatitis: Experimental #1988
- "EDP-305 favorably regulates lipoprotein mechanism in vitro"
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In vitro data demonstrates that EDP-305 maintains a positive
effect on lipoprotein metabolism under steatotic conditions by not
altering LDLR or SRB1 expression, without increasing ApoB secretion.
About EDP-305, a Farnesoid X Receptor (FXR) Agonist EDP-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, and
that may also be present in other classes of FXR agonists.
About NAFLD, NASH, and FXR Non-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 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 Enanta Enanta Pharmaceuticals has used its robust,
chemistry-driven approach and drug discovery capabilities to become a
leader in the discovery and development 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 U.S. marketed regimens MAVYRET™
(glecaprevir/pibrentasvir) and VIEKIRA PAK®
(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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171020005172/en/
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