Enanta Pharmaceuticals Presents New Data for EDP-235, its Lead Oral Protease Inhibitor Designed for the Treatment of COVID-19, at the ISIRV–WHO Virtual Conference 2021
October 19 2021 - 7:00AM
Business Wire
- Demonstrated Highly Potent Antiviral Activity
Against SARS-CoV-2 in Cellular Models -
- Once-Daily, Oral Dosing Supported by
Optimized Pharmacokinetic Properties -
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-235, its recently announced lead oral
protease inhibitor specifically designed for the treatment of
COVID-19. These data were presented in a poster titled “EDP-235, A
Potential Oral, Once-Daily Antiviral Treatment and Preventative for
COVID-19,” during the International Society for Influenza and Other
Respiratory Virus Diseases (ISIRV)–World Health Organization (WHO)
Virtual Conference 2021.
“We are excited to present preclinical data for the first time
on EDP-235, demonstrating potent inhibition of SARS-CoV-2
replication,” said Jay R. Luly, Ph.D., President and Chief
Executive Officer of Enanta Pharmaceuticals. “As the respiratory
tract is the initial site of SARS-CoV-2 infection, we are
particularly pleased to see good distribution of EDP-235 into lung
cells as well as other key target tissues. This combination of
potent antiviral activity and a favorable pharmacokinetic profile
positions EDP-235 to potentially be a best-in-class, once-daily
oral therapy for the treatment and prevention of COVID-19.”
Dr. Luly added, “Despite the availability of effective vaccines
against the virus, SARS-CoV-2 continues to persist worldwide,
demonstrating a critical need for a conveniently dosed, oral
antiviral therapy for COVID-19 that inhibits viral replication and
reduces disease progression. We have designed EDP-235 to meet this
need and look forward to advancing it into the clinic in early
2022.”
In a biochemical assay, EDP-235 inhibited the SARS-CoV-2 3CLpro
protease with an IC50 of 5.8 nM. Importantly, this activity was
retained against proteases from SARS-CoV-2 variants. EDP-235
potently blocked the replication of SARS-CoV-2 in multiple cellular
models, including primary human airway epithelial cells, where an
EC90 of 33 nM was observed. Additionally, EDP-235 was shown to have
potent antiviral activity across other human coronaviruses. In
comparison to preclinical data from other direct acting antivirals
in development for COVID-19 today, EDP-235 appears to be among the
most potent against SARS-CoV-2 in cellular assays.
EDP-235 showed good human Caco-2 cell permeability and a low
plasma clearance in human liver microsomes. Consistent with this in
vitro data, EDP-235 had robust plasma exposure with an oral
bioavailability of 95% in rats. Moreover, EDP-235 had favorable in
vivo penetration into multiple target tissues, including lung,
kidney, liver, and heart. These results indicate that EDP-235 has
good oral bioavailability and target tissue distribution compared
to other antivirals in development for SARS-CoV-2 today. Based on
allometric scaling, EDP-235 is projected to have a long half-life
of 16 hours with an efficacious dose of 100 to 500 mg once-daily in
humans. Taken together, these data indicate that EDP-235 has the
potential for once-daily oral dosing with a low pill burden.
Enanta has completed IND-enabling preclinical studies of EDP-235
and plans to advance the candidate into the clinic in early
2022.
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 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 EDP-235 for
the treatment of COVID-19. 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 disease areas such COVID-19; the
impact of development, regulatory and marketing efforts of others
with respect to competitive treatments for COVID-19; Enanta’s
limited clinical development experience; 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211019005265/en/
Media and Investor Contact Jennifer Viera 617-744-3848
jviera@enanta.com
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