Enanta Pharmaceuticals Completes Enrollment in Two Ongoing Phase 2 Studies
March 18 2019 - 6:30AM
Business Wire
- Respiratory Syncytial Virus (RSV)
Human Challenge Study with EDP-938
- ARGON-1 Study in Non-alcoholic
Steatohepatitis (NASH) with EDP-305
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 it has completed enrollment in two Phase 2 studies.
The Phase 2 study of EDP-938 in RSV is a randomized,
double-blind, placebo-controlled, human challenge study in healthy
adult subjects randomized into 1 of 2 dosing arms or a placebo arm.
Subjects are dosed for 5 days and receive a once-daily 600 mg dose,
a single 500 mg loading dose followed by 300 mg twice daily, or
placebo. Primary and secondary outcome measures include changes in
viral load measurements and changes in baseline symptoms. Topline
data is expected mid-calendar 2019.
The ARGON-1 study in NASH is a 12-week, randomized,
double-blind, placebo-controlled Phase 2 study evaluating the
safety, tolerability, pharmacokinetics and efficacy of EDP-305 in
subjects with NASH. The primary endpoint in the study is ALT
reduction and safety. Subjects receive placebo or a 1 mg or 2.5 mg
dose once daily for 12-weeks. Topline data is expected by the end
of the third quarter of calendar 2019.
More information on the designs of these studies can be found at
www.clinicaltrials.gov.
About EDP-938EDP-938, Enanta’s lead N-protein inhibitor,
is being developed for the treatment of RSV infection. Enanta
believes EDP-938 is differentiated from fusion inhibitors currently
in development by others for RSV because this N-protein inhibitor
targets the virus’ replication machinery and has demonstrated high
barriers to resistance against the virus in vitro. EDP-938 has also
been shown to reduce viral load below the level of detection in
vivo. Additionally, it is possible that N-protein inhibitors may be
effective treatments at later stages of infection.
About RSVRespiratory syncytial virus (RSV) is a virus
that infects the lungs and represents a serious unmet medical need
in infants and children, as well as immune-compromised individuals
and the elderly. RSV is the most common cause of bronchiolitis
(inflammation of the small airways in the lung) and pneumonia in
children under 1 year of age in the United States. Each year,
57,000 to 125,000 children in this group are hospitalized due to
RSV infection. Also, at increased risk of a severe RSV infection,
are children with compromised (weakened) immune systems due to a
medical condition or medical treatment, adults with compromised
immune systems and those 65 and older. There is currently no safe
and effective therapy for already established RSV infection.
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
associated with alcohol abuse. 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
(steatohepatitis) in addition to excessive fat. 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. 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.
About EnantaEnanta Pharmaceuticals 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 are currently focused on the
following disease targets: respiratory syncytial virus (RSV),
non-alcoholic steatohepatitis (NASH)/ primary biliary cholangitis
(PBC), and hepatitis B virus (HBV).
Enanta’s research and development activities are funded by
royalties from HCV products developed under its collaboration with
AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is
now sold by AbbVie in numerous countries as part of its newest
treatment for chronic hepatitis C virus (HCV) infection. This
leading HCV regimen is sold under the tradenames MAVYRET™ (U.S.)
and MAVIRET™ (ex-U.S.) (glecaprevir/pibrentasvir). Please visit
www.enanta.com for more information.
Forward Looking Statements DisclaimerThis press release
contains forward-looking statements, including statements with
respect to the prospects for further developments with respect to
EDP-938 for RSV and EDP-305 for NASH/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
development risks of early stage discovery efforts in the disease
areas in Enanta’s research and development pipeline, such as RSV,
NASH and PBC; the impact of development, regulatory and marketing
efforts of others with respect to competitive treatments for RSV,
NASH and PBC; 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-K for the fiscal year ended September
30, 2018 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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Investor ContactCarol
Miceli617-607-0710cmiceli@enanta.comMedia Contact:Kari
WatsonMacDougall Biomedical
Communications781-235-3060kwatson@macbiocom.com
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