Enanta Pharmaceuticals Announces New Data Presentations at the AASLD Liver Meeting

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 six poster presentations from Enanta’s wholly-owned development programs in non-alcoholic steatohepatitis (NASH) and hepatitis C virus (HCV) have been accepted for presentation at the Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place November 11-15, 2016 in Boston.
New data investigating Enanta’s Farnesoid X Receptor (FXR) EDP-305,
currently in Phase 1 development, will be presented demonstrating its
potency, selectivity and effects on fibrosis progression and lipid
metabolism in pre-clinical models. A new FXR preclinical lead compound
with enhanced potency, EP-024297, will also be characterized. Also being
presented will be single- and multiple-ascending dose data in healthy
volunteers, as well as preliminary viral kinetic data in genotype 1 and
genotype 3 HCV patients treated with EDP-494, Enanta’s novel
host-targeted cyclophilin inhibitor.
In addition, several presentations will report late-stage clinical data
in genotypes 1-6 from AbbVie’s chronic HCV clinical development program
of regimens containing glecaprevir, (ABT-493), Enanta’s second HCV
protease inhibitor, in combination with pibrentasvir, (ABT-530),
AbbVie’s NS5A inhibitor. There will also be several presentations
reporting data from AbbVie’s ongoing clinical development program for
its marketed HCV treatment regimens containing Enanta’s first protease
inhibitor, paritaprevir. Enanta’s protease inhibitors were identified
through its collaboration with AbbVie.
Enanta and AbbVie abstracts can now be viewed at the AASLD website at www.aasld.org.
Enanta Poster Presentations:
EDP-305 and EP-024297 FXR Agonists for Non-Alcoholic Steatohepatitis
(NASH)
#650 – The Novel Farnesoid X Receptor (FXR) agonist,
EDP-305, Reduces Fibrosis Progression in Bile Duct Ligated Rats

• November 11, 8:00 am to 5:30 pm ET
• Session: Imaging and Non-invasive Markers of Liver Disease
• Author: C. Farrar, et al.

#1540 – EDP-305, A Novel and Selective Farnesoid X Receptor Agonist,
Exhibits High Potency and Efficacy In Vitro and In Vivo

• November 13, 8:00 am to 5:30 pm ET
• Session: Steatohepatitis: Experimental I
• Author: Y. Li, et al.

#1568 – EDP-305, A Novel and Highly Potent Farnesoid X Receptor Agonist,
Exerts Favorable Effects on Lipid Metabolism In Vitro

• November 13, 8:00 am to 5:30 pm ET
• Session: Steatohepatitis: Experimental II
• Author: Y. Li, et al.

#1569 – EP-024297, A Novel and Selective Farnesoid X Receptor Agonist,
Exhibits High Potency and Efficacy In Vitro and In Vivo

• November 13, 8:00 am to 5:30 pm ET
• Session: Steatohepatitis: Experimental II
• Author: M. Chau, et al.

#1596 – EDP-305, A Novel and Potent Farnesoid X Receptor Agonist,
Exhibits Favorable Anti-inflammatory and Anti-fibrotic Activity In
Vitro

• November 13, 8:00 am to 5:30 pm ET
• Session: Steatohepatitis: Experimental II
• Author: Y. Li, et al.

EDP-494, Cyclophilin Inhibitor for HCV
#1453 – Safety,
Tolerability, Pharmacokinetics (PK) and Antiviral Activity of EDP-494, a
Potent Pan-Genotypic Cyclophilin (Cyp) Inhibitor for Chronic Hepatitis C
Infection (CHC), in Healthy Subjects (HS) and in CHC Genotype 1 and 3
Patients: Preliminary Results
• November 13, 8:00 am to 5:30 pm ET

• Session: HCV Therapeutics: Preclinical and Early Development
• Author: E. Gane, et al.

AbbVie Presentations Regarding glecaprevir (ABT-493) for HCV:
Oral
Presentations:
#73 – ENDURANCE 2: Safety and Efficacy of
ABT-493/ABT-530 in Hepatitis C Virus Genotype 2-infected Patients
without Cirrhosis, a Randomized, Double-Blind, Placebo-Controlled Study

• November 13, Parallel E (Session 6-13); Parallel 11: Hepatitis C: New
  and Existing Agents
• Time: 3:00 to 4:30 pm ET
• Author: K. Kowdley, et al.

#113 – SURVEYOR II, Part 3: Efficacy and Safety of ABT-493/ABT-530 in
Patients with Hepatitis C Virus Genotype 3 Infection with Prior
Treatment Experience and/or Cirrhosis

• November 13, Parallel F, (Sessions 14-20); Parallel 17: Hepatitis C:
  Phase 2/3 Trials
• Time: 4:45 to 6:15 pm ET
• Author: D. Wyles, et al.

#114 – ENDURANCE 4: Efficacy and Safety of ABT-493/ ABT-530 Treatment in
Patients with Chronic HCV Genotype 4, 5, or 6 Infection

• November 13, Parallel F (Sessions 14 – 20); Parallel 17: Hepatitis C:
  Phase 2/3 Trials
• Time: 4:45 to 6:15 pm ET
• Author: T. Asselah, et al.

#253 – ENDURANCE 1: Efficacy and Safety of 8- versus 12-week Treatment
with ABT-493/ABT-530 in patients with Chronic HCV Genotype 1 Infection

• November 15, Viral Hepatitis Plenary Session
• Time: 9:30 to 11:00 am ET
• Author: S. Zeuzem, et al.

Poster PresentationsRegarding glecaprevir (ABT-493):
#849
– Analysis of HCV Variants in the MAGELLAN-1 Part 1 Study: ABT-493 and
ABT-530 Combination Therapy of Genotype 1-Infected Patients Who Had
Failed Prior Direct Acting Antiviral-Containing Regimens

• November 12, Poster Session II
• Time: 5:30 to 7:30 pm ET
• Author: T. Ng, et al.

#854 – Drug-drug Interactions between Direct Acting Antivirals ABT-493
and ABT-530 with Angiotensin II Receptor Blockers (losartan or valsartan)

• November 12, Poster Session II
• Time: 5:30 to 7:30 pm ET
• Author: M Kosloski, et al.

#855 – Hemodialysis Does Not Affect the Pharmacokinetics of ABT‐493 or
ABT‐530

• November 12, Poster Session II
• Time: 5:30 to 7:30 pm ET
• Author: M Kosloski, et al.

About Enanta
Enanta 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 glecaprevir (ABT-493), Enanta’s second protease inhibitor,
which AbbVie is developing in Phase 3 studies in combination with
pibrentasvir (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, an FXR agonist product candidate for NASH,
currently in Phase 1 clinical development. Please visit www.enanta.com
for more information on our programs and pipeline.
Forward Looking Statements Disclaimer
This press release
contains forward-looking statements, including statements with respect
to the prospects for AbbVie’s investigational HCV treatment regimen
containing glecaprevir (ABT-493) and the prospects for Enanta’s further
development of EDP-494, EDP-305 other FXR agonists. 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 efforts of AbbVie (our collaborator developing glecaprevir)
to develop and obtain regulatory approval of its regimen containing
glecaprevir and successfully commercialize it; the development risks of
early stage discovery efforts in HCV and in new disease areas such as
NASH; the development, regulatory and marketing efforts of others with
respect to competitive treatment regimens for HCV or for NASH;
regulatory and reimbursement actions affecting any
glecaprevir-containing HCV regimen, any competitive regimen, or both;
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.