Enanta Pharmaceuticals Presents New Data for EDP-721, an Oral Hepatitis B Virus RNA Destabilizer, at the European Association...
June 23 2021 - 2:01AM
Business Wire
Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage
biotechnology company dedicated to creating small molecule drugs
for viral infections and liver diseases, today reported new
preclinical data for EDP-721, a novel, oral hepatitis B virus (HBV)
RNA destabilizer being developed for use in an all-oral combination
regimen for HBV. The data demonstrate potent, selective and
pangenotypic inhibition of HBV surface antigen (HBsAg), with up to
a 3-log drop in the AAV-HBV mouse model. The research on EDP-721
was presented in a poster titled Discovery and Characterization of
EDP-721, a Novel Hepatitis B Virus RNA Destabilizer, during the
EASL International Liver Congress™ 2021.
“The data presented today strongly support the continued
development of EDP-721 for use in an all-oral regimen to provide a
functional cure for HBV,” said Jay R. Luly, Ph.D., President and
Chief Executive Officer of Enanta Pharmaceuticals. “While existing
therapies for chronic HBV are moderately effective at suppressing
HBV DNA, high levels of HBsAg present a key barrier to enduring
viral clearance. These new preclinical data demonstrate that
EDP-721 significantly reduced HBsAg production up to 3 logs and
exhibited additive to synergistic activity with antivirals that
target different mechanisms. We look forward to initiating a Phase
1 trial evaluating EDP-721 in mid-2021 and subsequently studying
the compound in combination with other mechanisms, including our
core inhibitor, EDP-514, and nucleoside reverse transcriptase
inhibitors.”
EDP-721 was shown to be a selective inhibitor of the
non-canonical poly(A) polymerases, PAPD5 and PAPD7, 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 logs 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.
Enanta expects to initiate a Phase 1 single ascending dose (SAD)
and multiple ascending dose (MAD) study to evaluate the safety and
tolerability of EDP-721 in healthy volunteers in mid-2021.
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. It is estimated
that over 290 million people worldwide have chronic HBV infection.1
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.2 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.3
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)
and non-alcoholic steatohepatitis (NASH). Enanta is also conducting
research in SARS-CoV-2 (COVID-19) and 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 March 31, 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.
_____________________________
1https://pubmed.ncbi.nlm.nih.gov/29599078/
2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5401664/
3https://pubmed.ncbi.nlm.nih.gov/30342034/
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version on businesswire.com: https://www.businesswire.com/news/home/20210622006097/en/
Media and Investor Contact Jennifer Viera 617-744-3848
jviera@enanta.com
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