Enanta to Present New Data for Core Inhibitor for Hepatitis B Virus & FXR Agonist EDP-305 for NASH at The International Liver...
April 12 2018 - 2:00AM
Business Wire
- Oral presentation will demonstrate
novel core inhibitor EP-027367 reduces hepatitis B virus DNA levels
up to 3.0 logs from baseline in HBV viral titers with 4 weeks of
treatment in a humanized mouse model
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 data from Enanta’s wholly-owned development
programs, including EP-027367, one of Enanta’s novel core
inhibitors in preclinical testing targeting hepatitis B virus
(HBV), and EDP-305, an FXR agonist in development for non-alcoholic
steatohepatitis (NASH) and primary biliary cholangitis (PBC), will
be presented at The International Liver Congress™ (ILC) 2018 taking
place this week in Paris, France.
The abstract titled, “Discovery of a novel HBV core inhibitor
EP-027367 with potent antiviral activity both in vitro and in a
humanized mouse model” will be presented today at 17:45 CET in an
oral presentation. EP-027367 is one of several core inhibitors
Enanta is evaluating for hepatitis B virus. Core inhibitors,
sometimes referred to as capsid assembly modulators, are a new
class of HBV inhibitors that can disrupt the assembly and
replication of the virus at multiple steps in the virus lifecycle.
Data being presented today will demonstrate that in a chimeric
mouse model with human liver cells, EP-027367 reduced hepatitis B
virus DNA levels by up to 3.0 logs from baseline in HBV viral
titers with 4 weeks of treatment and demonstrated a favorable
tolerability and pharmacokinetic profile. EP-027367 has also
demonstrated potent, pan-genotypic, anti-HBV activity capable of
preventing the establishment of cccDNA in vitro.
There will also be three posters on EDP-305, Enanta’s FXR
agonist currently in a Phase 2 study for NASH and a Phase 2 study
for PBC. One poster will highlight new preclinical data
demonstrating EDP-305 favorably regulates the expression of key
fibrogenic genes in vitro and in vivo and a second will show
EDP-305 has distinct transcriptional and post-transcriptional
regulatory mechanisms for LDLR and SRB1 expression. A third poster
will present data from our previously released phase 1 study
highlighting the pharmacokinetics, pharmacodynamics and safety of
EDP-305 in healthy and presumptive NAFLD subjects. The U.S. Food
and Drug Administration has granted EDP-305 Fast Track designation
for the treatment of NASH patients with liver fibrosis and Fast
Track designation for the treatment of patients with PBC.
The full ILC 2018 scientific program as well as the abstracts
can be found at http://ilc-congress.eu/. Further details will be
available at the time of these presentations.
Oral Presentation:
- Thursday, April 12, 17:45 - 18:00
CETPS-032 - “Discovery of a novel HBV core inhibitor EP-027367
with potent antiviral activity both in vitro and in a humanized
mouse model” (M. Vaine, S. Clugston, J. Kass, X. Gao, H. Cao, W.
Li, X. Peng, L.J. Jiang, K. Daniels, Y. Qiu, Y.S. Or, K. Lin)
Poster PresentationsThursday, April 12, 09:00 - 17:00
CET
- THU-469 - “EDP-305 modulates
lipoprotein metabolism via distinct chromatin and microRNA
regulatory mechanisms” (M. Roqueta-Rivera, M.D. Chau, K. Garlick,
Y. Li, G. Wang, Y.S. Or, and L.J. Jiang)
Friday, April 13, 09:00 - 17:00 CET
- FRI-084 - “EDP-305, a highly selective
and potent farnesoid X receptor agonist, favorably regulates the
expression of key fibrogenic genes in vitro and in vivo” (Y. Li,
J.Y. Shang, M.D. Chau, M. Roqueta-Rivera, K. Garlick, P. An, K.
Vaid, G. Wang, Y. Popov, Y.S. Or, and L.J. Jiang)
- FRI-489 - “Pharmacokinetics,
pharmacodynamics, and safety of EDP-305, in healthy and presumptive
NAFLD subjects” (A. Ahmad, K. Sanderson, D. Dickerson, N.
Adda)
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,
glecaprevir and paritaprevir, 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 regimens marketed as MAVYRET™ (U.S.)
and MAVIRET™ (ex-U.S.) (glecaprevir/pibrentasvir) and VIEKIRA PAK®
(paritaprevir/ritonavir/ombitasvir/dasabuvir) (U.S.) and VIEKIRAX®
(paritaprevir/ritonavir/ombitasvir) (ex-U.S.).
Royalties 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 Statements DisclaimerThis press release
contains forward-looking statements, including statements with
respect to the prospects for Enanta’s further development of
EDP-305 and EP-027367. 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
Enanta’s early stage discovery efforts in NASH, PBC and HBV;
potential competition from the development efforts of others in
these disease areas; Enanta’s lack of clinical development
experience; Enanta’s need to attract and retain senior management
and key scientific personnel; the need to obtain and maintain
patent protection for Enanta’s 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 fiscal quarter
ended December 31, 2017 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: https://www.businesswire.com/news/home/20180411006271/en/
Investor ContactEnanta PharmaceuticalsCarol Miceli,
617-607-0710cmiceli@enanta.comorMedia
ContactMacDougall Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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