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Enanta to Present New Data for Core Inhibitor for Hepatitis B Virus and FXR Agonist EDP-305 for NASH at The International Liver Congress™ 2018

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  • 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 CET
    PS-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 Presentations
Thursday, 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 Enanta
Enanta 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 Disclaimer
This 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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