Enanta Pharmaceuticals Initiates Phase 1 Clinical Study of EDP-297, its Highly Potent & Targeted Follow-On Farnesoid X Recept...
14 September 2020 - 9:00PM
Business Wire
-- Initial clinical data including safety,
tolerability and pharmacokinetics expected in 2Q 2021 –
Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a clinical stage
biotechnology company dedicated to creating small molecule drugs
for viral infections and liver diseases, today announced that it
has dosed the first subjects in its Phase 1 clinical trial of
EDP-297, a highly potent and targeted follow-on farnesoid X
receptor (FXR) agonist, being developed for the treatment of
non-alcoholic steatohepatitis (NASH).
“We are excited to advance our efforts in NASH and progress
EDP-297, our follow-on FXR agonist, into clinical development,”
commented Jay R. Luly, Ph.D., President and Chief Executive Officer
of Enanta Pharmaceuticals. “In preclinical studies, EDP-297
demonstrated a compelling product profile, with a potency greater
than that published on any FXR agonist in clinical development and
high target-tissue distribution in the liver and intestine. Based
on these data, we believe we may be able to effectively dose
EDP-297 at lower doses and with reduced drug levels in non-targeted
tissues, potentially improving tolerability by reducing pruritis.
We look forward to reporting clinical data in the second quarter of
2021.”
The Phase 1, randomized, double-blind, placebo-controlled,
first-in-human study is designed to assess the safety,
tolerability, and pharmacokinetics, including the effect of food
intake, of orally administered EDP-297 in approximately 74 healthy
adult subjects. Two phases are planned: a single ascending dose
phase enrolling six cohorts, including a two-part food effect
cohort, and a multiple ascending dose phase enrolling three
cohorts.
In two recent poster presentations at the European Association
for the Study of the Liver (EASL) Digital International Liver
Congress™ 2020, treatment with EDP-297 demonstrated significantly
reduced fibrosis progression and improved liver function in a rat
model of NASH. Additionally, in 3D NASH microtissues, EDP-297
modulated multiple pathways associated with the pathogenesis of
NASH, including decreased expression of genes encoding multiple
lipogenic and inflammatory proteins, and significantly reduced
expression of inflammatory and fibrotic genes and normalized
circulating markers of liver injury.
About NASH and FXR
NASH is a serious form of non-alcoholic fatty liver disease
(NAFLD) which is common in the United States and around the world
and is closely associated with diabetes and obesity. Characterized
by an excessive build-up of fat in the liver causing stress and
damage to liver cells, NASH can lead to inflammation and fibrosis,
causing permanent damage, including cirrhosis and impaired liver
function, as well as cancer and eventually death. NASH is the
leading cause of liver transplants in the United States and Europe
and currently has no FDA-approved treatment.1 A farnesoid X
receptor is 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-297, a FXR Agonist
EDP-297 is a potent FXR agonist and Enanta’s follow-on FXR
agonist candidate being developed for the treatment of NASH.
EDP-297 represents a class of FXR agonists that has been designed
to take advantage of increased binding interactions with the
receptor. Preclinical findings of EDP-297 demonstrate potent
anti-fibrotic, anti-inflammatory and hepatoprotective effects.
EDP-297 has demonstrated preclinical potency greater than that
published on any FXR agonist in clinical development today.
Further, in preclinical models EDP-297 has been shown to be
targeted to tissues important for efficacy, namely liver and
intestine, versus plasma and skin.
About Enanta
Enanta is using 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. Enanta’s research and development
efforts have produced clinical candidates for the following disease
targets: respiratory syncytial virus (RSV), non-alcoholic
steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also
conducting research in human metapneumovirus (hMPV) and SARS-CoV-2
(COVID-19).
Enanta’s research and development activities are funded by
royalties from hepatitis C virus (HCV) products developed under its
collaboration with AbbVie. Glecaprevir, a protease inhibitor
discovered by Enanta, is sold by AbbVie in numerous countries as
part of its leading treatment for chronic HCV infection under the
tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.)
(glecaprevir/pibrentasvir). Please visit www.enanta.com for more
information.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for further
development of EDP-297 for 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 the disease areas in Enanta’s
research and development pipeline, such as NASH; the impact of
development, regulatory and marketing efforts of others with
respect to competitive treatments for NASH; Enanta’s limited
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-Q for
the quarter ended June 30, 2020 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.
1
https://www.worldhepatitisalliance.org/latest-news/infohep/3548835/nash-fastest-growing-reason-liver-transplant-united-states
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200914005201/en/
Investor Contact Jennifer Viera 617-744-3848
jviera@enanta.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Apr 2024 to May 2024
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From May 2023 to May 2024