Enanta Pharmaceuticals Announces AbbVie’s Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation
September 30 2016 - 8:08AM
Business Wire
- Investigational regimen includes
Enanta’s protease inhibitor glecaprevir (ABT-493)
- Breakthrough Therapy Designation
granted based on Phase 2 clinical data for genotype 1 (GT1)
patients who failed previous therapy with direct-acting antivirals
(DAAs)
- Currently in Phase 3 clinical trials,
glecaprevir/pibrentasvir (G/P) is an investigational, pan-genotypic
regimen being evaluated for the treatment of chronic hepatitis C
virus (HCV) genotypes 1-6
- Breakthrough Therapy Designation is
granted to investigational treatments for serious or
life-threatening conditions with preliminary clinical evidence that
may demonstrate substantial improvement over existing
therapies
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 the U.S. Food and Drug Administration (FDA) has
granted Breakthrough Therapy Designation (BTD) for AbbVie’s
investigational, pan-genotypic regimen of glecaprevir
(ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of
patients with chronic hepatitis C virus (HCV) who failed previous
therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1),
including previous therapy with an NS5A inhibitor and/or protease
inhibitor.
The BTD is supported by positive results seen in AbbVie’s Phase
2 MAGELLAN-1 clinical study. According to the FDA, BTD is intended
to expedite the development and review of an investigational
therapy for a serious or life threatening condition when there is
preliminary clinical evidence that the therapy may demonstrate
substantial improvement over any existing therapy.1
“The FDA’s Breakthrough Therapy Designation is an important step
for AbbVie’s efforts to bring to market its pan-genotypic HCV
medicine containing our second-generation protease inhibitor,”
stated Jay R. Luly, Ph.D., CEO of Enanta. “AbbVie is also
investigating an eight-week regimen of G/P for the majority of
patients. We look forward to release of additional clinical data on
G/P in the coming months.”
Glecaprevir (GLE) is Enanta’s second protease inhibitor being
developed through its collaboration with AbbVie. AbbVie’s
investigational regimen includes GLE, an NS3/4A protease inhibitor,
and pibrentasvir (PIB), an NS5A inhibitor, which are co-formulated
and dosed once daily as three oral tablets.
AbbVie will present new Phase 3 data evaluating the safety and
efficacy of G/P across all major HCV genotypes (genotypes 1-6) at
an upcoming scientific congress. There is additional information on
the clinical trials for G/P conducted by AbbVie available at
www.clinicaltrials.gov.
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 ABT-493, Enanta’s
second protease inhibitor, which AbbVie is developing in Phase 3
studies in combination with 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, a non-bile
acid FXR agonist 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.
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 any
regimens containing glecaprevir and successfully commercialize
them; the development, regulatory and marketing efforts of others
with respect to competitive HCV treatment regimens; regulatory and
reimbursement actions affecting any glecaprevir-containing HCV
regimen, any competitive regimen, or both; 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.
1 U.S. Food
and Drug Administration. Fact Sheet: Breakthrough Therapies.
http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm.
Accessed September 1, 2016.
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version on businesswire.com: http://www.businesswire.com/news/home/20160930005336/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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