Enanta Pharmaceuticals Announces Nomination of Clinical Candidate EDP-235, its Lead Oral Protease Inhibitor Specifically Designed for the Treatment of COVID-19
August 05 2021 - 7:00AM
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 announced the
nomination of EDP-235, its lead oral protease inhibitor
specifically designed for the treatment of COVID-19. Enanta plans
to advance EDP-235 into the clinic early next year.
“The nomination of EDP-235 represents an important milestone for
Enanta and highlights the strength of our experience in developing
small molecule drugs for the treatment of viral infections at this
critical time in the global fight against COVID-19,” said Jay R.
Luly, Ph.D., President and Chief Executive Officer of Enanta
Pharmaceuticals. “As the virus continues to rapidly mutate, there
remains a need for an oral, direct-acting antiviral that potently
inhibits viral replication. While vaccines and antibody
therapeutics in development today target the viral spike protein,
EDP-235 has been specifically designed to target conserved regions
in the active site of a viral enzyme essential for SARS-CoV-2
replication, so we do not expect mutations in the spike protein to
affect the activity of our candidate. We are encouraged by the
promising preclinical data generated to date, which has
demonstrated potent and selective inhibition of SARS-CoV-2, and we
look forward to progressing EDP-235 into the clinic.”
EDP-235 potently and selectively inhibits SARS-CoV-2 replication
in multiple cellular models, including primary human airway
epithelial cells, with an EC90 of 33nM. EDP-235 retained activity
against protease enzymes from currently circulating SARS-CoV-2
variants. Additionally, EDP-235 has a clean preclinical safety
profile and has demonstrated a high barrier to resistance.
Importantly, EDP-235 has excellent lung distribution in rats and
demonstrates properties supportive of once daily oral dosing, in
contrast to other protease inhibitors currently in development.
Furthermore, EDP-235 has shown activity against other
coronaviruses, providing the opportunity to potentially treat other
infections that may emerge in the future.
Enanta will apply for Fast Track designation and expects to
initiate a Phase 1 single and multiple ascending dose study to
evaluate the safety, tolerability, and pharmacokinetics of EDP-235
in approximately 75 healthy volunteers 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 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-235 for SARS-CoV-2. 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 risks
of early stage development efforts in the disease areas in Enanta’s
research and development pipeline, such as 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210805005138/en/
Media and Investor Contact Jennifer Viera 617-744-3848
jviera@enanta.com
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