Enanta Pharmaceuticals Announces Update to its Hepatitis B Virus (HBV) Program
November 18 2021 - 4:01PM
Business Wire
Discontinuing Clinical Development of EDP-721,
an Oral HBV RNA Destabilizer
Continuing to Focus on Development of EDP-514
in Combination Regimens as a Functional Cure for HBV
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage
biotechnology company dedicated to creating small molecule drugs
for viral infections and liver diseases, today announced it is
discontinuing development of EDP-721, an oral HBV RNA destabilizer,
based on emerging safety observations in the single ascending dose
part of a Phase 1 study in healthy volunteers.
“Despite the clean preclinical safety profile demonstrated in
comprehensive toxicology studies, safety signals were seen in
healthy subjects after administration of EDP-721. Patient safety is
our top priority, and we have therefore decided to discontinue
further development of this compound,” said Jay R. Luly Ph.D.,
President and Chief Executive Officer of Enanta Pharmaceuticals.
“We are committed to developing a functional cure for chronic
hepatitis B patients, and remain confident in EDP-514, our HBV core
inhibitor, which has demonstrated safe and robust antiviral
activity in Phase 1b studies of viremic and NUC-suppressed patients
with chronic HBV infection. We believe core inhibitors will be an
important component of a successful combination regimen, and we
will look to advance our HBV program with additional mechanisms
from internal discovery efforts, external opportunities, or both.
Importantly, we are grateful to our Principal Investigator and his
study team, and the participants in the Phase 1 study for their
commitment to HBV research, and to our team for all their efforts
in supporting the development and clinical evaluation of
EDP-721."
About Hepatitis B Virus
Hepatitis B is a viral infection that attacks the liver and can
cause both acute and chronic disease. The virus is most commonly
transmitted from mother to child during birth and delivery, as well
as through contact with blood or other body fluids.1 It is
estimated that over 290 million people worldwide have chronic HBV
infection.2 Current approaches to treatment include interferon
therapy and/or nucleos(t)ide reverse transcriptase inhibitors.
Treatment with interferon offers poor cure rates and is accompanied
by serious side effects.3 Nucleos(t)ide reverse transcriptase
inhibitors can be very effective at suppressing the virus but
rarely result in full eradication of the virus from the liver.4
About Enanta
Enanta is using its robust, chemistry-driven approach and drug
discovery capabilities to become a leader in the discovery and
development of small molecule drugs for the treatment of viral
infections and liver diseases. Enanta’s research and development
efforts have produced clinical candidates currently in development
for the following disease targets: respiratory syncytial virus
(RSV), hepatitis B virus (HBV) and SARS-CoV-2 (COVID-19). Enanta is
also conducting research in human metapneumovirus (hMPV).
Enanta’s research and development activities are funded by
royalties from hepatitis C virus (HCV) products developed under its
collaboration with AbbVie. Glecaprevir, a protease inhibitor
discovered by Enanta, is part of AbbVie’s leading treatment for
chronic HCV infection that it sells in numerous countries under the
tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.)
(glecaprevir/pibrentasvir). 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 further
development of EDP-514 for HBV. 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
early stage discovery efforts in the disease areas in Enanta’s
research and development pipeline, such as HBV; the impact of
development, regulatory and marketing efforts of others with
respect to competitive treatments for HBV; Enanta’s limited
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-Q for
the quarter ended June 30, 2021 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.
https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
2.
https://pubmed.ncbi.nlm.nih.gov/29599078/
3.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5401664/
4.
https://pubmed.ncbi.nlm.nih.gov/30342034/
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211118006197/en/
Media and Investor Contact Jennifer Viera 617-744-3848
jviera@enanta.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Jul 2023 to Jul 2024