- New pre-clinical data to be presented
on Enanta’s FXR agonist EDP-305 for non-alcoholic steatohepatitis
(NASH)
- Preliminary Phase 1 data to be
presented on Enanta’s novel host-targeted cyclophilin inhibitor
EDP-494 for hepatitis C virus (HCV) patients.
- New Phase 3 data to be presented on
AbbVie’s investigational, pan-genotypic regimen for HCV consisting
of glecaprevir (ABT-493), Enanta’s second protease inhibitor, in
combination with pibrentasvir (ABT-530), AbbVie’s NS5A
Inhibitor
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 Presentations Regarding 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 EnantaEnanta 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 DisclaimerThis 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161003005798/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Apr 2023 to Apr 2024