Enanta Pharmaceuticals Initiates Phase 1 Clinical Study of EDP-305, its Lead FXR Agonist for the Treatment of Non-alcoholic S...
September 28 2016 - 4:12PM
Business Wire
- First subjects dosed in study that will
evaluate EDP-305 in healthy subjects and subjects with presumptive
non-alcoholic fatty liver disease (NAFLD)
Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases, today
announced that it has initiated a Phase 1 clinical study and has
begun dosing healthy adults with EDP-305, Enanta’s lead farnesoid X
receptor (FXR) agonist under development to treat patients with
NASH.
The double-blind, placebo-controlled Phase 1a/b study is
designed to evaluate the safety, tolerability and pharmacokinetics
of single ascending doses (SAD) and multiple ascending doses (MAD)
of EDP-305 in healthy adults, and in adults with presumptive NAFLD
(obese, with or without pre-diabetes or type 2 diabetes mellitus).
The study will enroll approximately 90 subjects and is designed to
evaluate up to 5 dose cohorts, with EDP-305 administered orally,
once daily.
The current study will include subjects with presumptive NAFLD
in order to obtain initial safety data and additional data
regarding the relationship between EDP-305 plasma concentration
levels and certain pharmacological effects in the context of fatty
liver disease. This relationship will be explored by using
bio-markers that are relevant to the disease and to the activity of
EDP-305, such as evaluation of lipids, glucose, insulin resistance
and specific markers of FXR activity.
“This expanded Phase 1 study design was driven by extensive
preclinical data that demonstrate that EDP-305 is a highly
selective FXR agonist that shows potent activity in a variety of in
vitro assays and in vivo NASH and fibrosis models,” commented Jay
R. Luly, Ph.D. “As part of a more complete characterization of
EDP-305, we expect to share data regarding fibrosis and other
preclinical data in November at The Liver Meeting® in Boston.”
About NAFLD, NASH, and FXRNon-alcoholic fatty liver
disease (NAFLD) is the accumulation in patients of excessive fat in
the form of triglycerides in 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 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.
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 steroid
and non-steroid components, and does not contain the carboxylic
acid group normally present in other classes of FXR agonists and
natural bile acids that can lead to the formation of taurine and
glycine conjugates. EDP-305 is currently in Phase 1 clinical
development.
About EnantaEnanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases.
Enanta’s research and development efforts are currently focused on
four disease targets: Hepatitis C Virus (HCV), Hepatitis B Virus
(HBV), Non-alcoholic Steatohepatitis (NASH) and Respiratory
Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors and NS5A
inhibitors that are members of the direct-acting-antiviral (DAA)
inhibitor classes designed for use against the hepatitis C virus
(HCV). Enanta’s protease inhibitors, developed through its
collaboration with AbbVie, include paritaprevir, which is contained
in AbbVie’s marketed DAA regimens for HCV, and ABT-493, Enanta’s
second protease inhibitor, which AbbVie is developing in Phase 3
studies in combination with ABT-530, AbbVie’s NS5A inhibitor.
Enanta has also discovered a cyclophilin inhibitor, EDP-494, a
novel host-targeting mechanism for HCV, which is now in a clinical
proof of concept study in HCV patients, and EDP-305, a non-bile
acid FXR agonist for NASH, currently in Phase 1 clinical
development. Please visit www.enanta.com for more information on
our programs and pipeline.
Forward Looking Statements DisclaimerThis press release
contains forward-looking statements, including statements with
respect to the prospects for clinical development of one of
Enanta’s early lead compounds for the treatment of NASH. 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
development risks of early stage discovery efforts in disease areas
such as NASH that have no current therapeutic treatment; potential
competition from the development efforts of others in this disease
area; Enanta’s lack 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, 2015 and 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/20160928006459/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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