Enanta Pharmaceuticals Doses First Subject in a Phase 1 Clinical Study of EDP-721, Its Oral Hepatitis B Virus RNA Destabilizer
August 16 2021 - 6:00AM
Business Wire
- Initial Data Expected in the First Half of
2022 -
Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a clinical stage
biotechnology company dedicated to creating small molecule drugs
for viral infections and liver diseases, today announced that it
has dosed the first subject in its Phase 1 clinical trial of
EDP-721, a novel, oral hepatitis B virus (HBV) RNA destabilizer
being developed for use in an all-oral combination regimen for
chronic HBV patients.
“We are pleased to advance our HBV program by dosing the first
subject in our Phase 1 clinical study of EDP-721, an orally
administered HBV RNA destabilizer that has the potential to reduce
S antigen. As we believe that achieving a functional cure for HBV
will involve a combination approach, this milestone brings us
closer to our vision of developing an all-oral regimen for HBV,”
said Jay R. Luly, Ph.D., President and Chief Executive Officer of
Enanta Pharmaceuticals. “The current standard of care for chronic
HBV involves nucleoside reverse transcriptase inhibitors, or NUCs,
which can suppress HBV replication. In addition, EDP-514, our
potent core inhibitor inhibits several stages of HBV replication,
from uncoating and nuclear import of the virus, to capsid assembly
and recycling. Now, with EDP-721, we have an oral compound that has
demonstrated preclinically the ability to destabilize HBV RNAs,
leading to a reduction in viral proteins, including S antigen,
which we believe is essential for the treatment of HBV. With this
triple combination of a NUC, EDP-514, and EDP-721, we see the
potential for an all-oral functional cure and look forward to
progressing this study.”
This two-part Phase 1a/b study will initially evaluate the
safety, tolerability, and pharmacokinetics of EDP-721 in single and
multiple ascending oral doses in healthy volunteers. The second
part, in chronic HBV patients, will evaluate the safety,
tolerability, pharmacokinetics, and antiviral activity of multiple
ascending oral doses of EDP-721 with or without a NUC, and then in
combination with EDP-514. Data from the first part of the study are
expected in the first half of 2022.
In a recent poster presentation at the European Association for
the Study of the Liver (EASL) Digital International Liver Congress™
2021, EDP-721 was shown to be a selective inhibitor of the
non-canonical poly(A) polymerases, PAPD5 and PAPD7, which are host
factors critical to the post-transcriptional stabilization of HBV
RNA. Inhibition of PAPD5/7 results in potent and pangenotypic
reduction in HBsAg production with minimal effects on the host
transcriptome in uninfected primary human hepatocytes. Oral
administration of EDP-721 demonstrated HBsAg reductions of up to 3
log10 IU/mL following 14 days of once-daily dosing in the AAV-HBV
mouse model. EDP-721 was also shown to exhibit synergistic
antiviral activity in vitro when combined with nucleos(t)ide
reverse transcriptase inhibitors or the HBV core inhibitor
EDP-514.
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 for the following disease
targets: respiratory syncytial virus (RSV), hepatitis B virus
(HBV), non-alcoholic steatohepatitis (NASH), 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 sold by AbbVie in numerous countries as
part of its leading treatment for chronic HCV infection 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-721 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/
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version on businesswire.com: https://www.businesswire.com/news/home/20210816005078/en/
Media and Investor Contact Jennifer Viera 617-744-3848
jviera@enanta.com
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