Enanta Announces New Data on ABT-450 Regimens to be Presented at The Liver Meeting (AASLD)
October 01 2013 - 10:15AM
Business Wire
Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA) a
research and development-focused biotechnology company dedicated to
creating small molecule drugs in the infectious disease field,
today announced that six abstracts reporting results of regimens
containing ABT-450, Enanta’s lead protease inhibitor for hepatitis
C virus (HCV), have been accepted for presentation at The Liver
Meeting, the 64th Annual Meeting of the American Association for
the Study of Liver Diseases (AASLD) taking place November 1-5, 2013
in Washington, D.C. Abstracts can now be viewed at the AASLD
website at www.aasld.org.
There will be an oral presentation at AASLD
highlighting data from study M13-393 (PEARL-I). PEARL-I is an
interferon-free and ribavirin-free 320-patient study being
conducted by Abbvie to evaluate the once-daily, two-DAA regimen
consisting of ABT-450/r + ABT-267 in GT-1b and GT-4 HCV patients.
SVR4 rates were 100% (39/39) in GT-1b treatment-naïve patients and
87.9% (29/33) among prior null responders (observed data). SVR12
rates will be presented during an oral presentation of this data on
November 3.
Abstracts reporting regimens containing ABT-450
are listed below:
Oral Presentation:
- #75 - Interferon and Ribavirin-Free
Regimen of ABT-450/r + ABT-267 in HCV Genotype 1b-infected
Treatment-naïve Patients and Prior Null RespondersLawitz, et
al., November 3, 2013, 5:15 PM ET
Poster Presentations:
- #1089 - Low Relapse Rate Leads to
High Concordance of SVR4 and SVR12 with SVR24 After Treatment with
ABT-450/r, ABT-267, ABT-333 + Ribavirin in Patients with Chronic
HCV Genotype 1 Infection in the AVIATOR StudyPoordad, et al.,
November 3, 2013, 8:00 AM – 5:30 PM ET
- #1096 - High Medication Adherence in
HCV-Infected Patients taking a Triple-DAA Regimen for 12
WeeksBourliere, et al., November 3, 2013, 8:00 AM – 5:30 PM
ET
- #1125 - HCV RNA “Target Detected”
after “Target Not Detected” During IFN-Free Treatment: Time to
Worry or Not?M King, et al., November 3, 2013, 8:00 AM – 5:30
PM ET
- #1118 - Safety of
Ribavirin-containing Regimens of ABT-450/r, ABT-333, and ABT-267
for the Treatment of HCV Genotype 1 Infection and Efficacy in
Subjects with Ribavirin Dose ReductionsCohen, et al., November
3, 2013, 8:00 AM – 5:30 PM ET
- #1113 - Health-Related Quality of
Life (HRQoL), Health State, Function and Wellbeing of Chronic HCV
Patients Treated with Interferon-Free, Oral DAA Regimens: Patient
Reported Outcome (PRO) Results from the AVIATOR StudyBaran, et
al., November 3, 2013, 8:00 AM – 5:30 PM ET
Protease Inhibitor Collaboration with AbbVie
(formerly the research-based pharmaceutical business of Abbott
Laboratories)
In December 2006, Enanta and Abbott announced a
worldwide agreement to collaborate on the discovery, development
and commercialization of HCV NS3 and NS3/4A protease inhibitors and
HCV protease inhibitor-containing drug combinations. ABT-450 is a
protease inhibitor identified as a lead compound through the
collaboration. Under the agreement, AbbVie (as the successor to
Abbott) is responsible for all development and commercialization
activities for ABT-450. Enanta received $57 million in connection
with signing the collaboration agreement, has received $55 million
in subsequent clinical milestone payments, and is eligible to
receive an additional $195 million in payments for regulatory
milestones, as well as double-digit royalties worldwide on any
revenue allocable to the collaboration’s protease inhibitors. Also,
for any additional collaborative HCV protease inhibitor product
candidate developed under the agreement, Enanta holds an option to
modify the U.S. portion of it rights to receive milestone payments
and worldwide royalties. With this option, Enanta can fund 40
percent of U.S. development costs and U.S. commercialization
efforts (sales and promotion costs) for the additional
protease inhibitor in exchange for 40 percent of any U.S.
profits ultimately achieved after regulatory approval instead
of receiving payments for U.S. commercial regulatory
approval milestones and royalties on U.S. sales of that protease
inhibitor.
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 in the infectious disease field. Enanta is
discovering and developing novel inhibitors designed for use
against the hepatitis C virus (HCV). These inhibitors include
members of the direct acting antiviral (DAA) inhibitor classes –
protease (partnered with AbbVie), NS5A (partnered with Novartis)
and nucleotide polymerase – as well as a host-targeted antiviral
(HTA) inhibitor class targeted against cyclophilin. Additionally,
Enanta has created a new class of antibiotics, called Bicyclolides,
for the treatment of multi-drug resistant bacteria, with a focus on
developing an intravenous and oral treatment for hospital and
community MRSA (methicillin-resistant Staphylococcus aureus)
infections.
Forward Looking Statements
Disclaimer
This press release contains forward-looking
statements, including with respect to clinical data, plans for
announcing additional data, and the planned clinical development of
ABT-450. Statements that are not historical facts are based on our
management’s current expectations, estimates, forecasts and
projections about our business and the industry in which we operate
and our 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 that may affect actual results
include final results of ongoing clinical trials, the development
and marketing efforts of AbbVie (our collaborator on ABT-450),
regulatory actions affecting clinical development of ABT-450 and
clinical development of competitive product candidates. 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.
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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