Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-235, its Oral 3CL Protease Inhibitor Specifically Designed for the Treatment and Prevention of COVID-19
March 29 2022 - 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 that the
U.S. Food and Drug Administration (FDA) has granted Fast Track
designation for EDP-235, its coronavirus 3CL protease inhibitor
(also known as the main coronavirus protease, or Mpro) specifically
designed as a once-daily, oral treatment for COVID-19.
"Despite the broad availability of vaccines, there remains a
need for highly potent, oral treatments specifically designed to
target SARS-CoV-2, a virus that continues to persist and mutate
globally. Receiving Fast Track designation from the FDA underscores
EDP-235’s potential as a once-daily, oral therapeutic for the
treatment and prevention of SARS-CoV-2 infection and as another
option in the global fight against the ongoing pandemic,” said Jay
R. Luly, Ph.D., President and Chief Executive Officer of Enanta
Pharmaceuticals. “We believe that the profile of EDP-235 positions
it as a potential best-in-class antiviral therapeutic and we remain
on track to report data from our ongoing Phase 1 study of EDP-235
next quarter. We look forward to working with the FDA to continue
to advance EDP-235 as expeditiously as possible."
The Fast Track program is designed to accelerate the development
and review of products such as EDP-235, which are intended to treat
serious diseases and for which there is an unmet medical need. Fast
Track designation enables more frequent communication with the FDA
and eligibility for FDA programs such as priority review and
rolling review, if relevant criteria are met.
Currently, EDP-235 is in a first-in-human Phase 1 study to
evaluate the safety, tolerability, and pharmacokinetics of oral
EDP-235 in single ascending doses (SAD), including a two-part food
effect cohort, and multiple ascending doses (MAD), compared to
placebo in healthy volunteers.
Preclinical data show that EDP-235 potently blocks the
replication of SARS-CoV-2 in multiple cellular models, including
primary human airway epithelial cells where an EC90 of 33 nanomolar
was observed, positioning EDP-235 among the most potent
direct-acting antivirals currently in development for SARS-CoV-2
infection. Preclinical studies demonstrate that EDP-235 has good
oral bioavailability without ritonavir boosting and favorable
distribution into lung cells as well as other key target tissues,
with expected once-daily human dosing. Importantly, in addition to
SARS-CoV-2, EDP-235 has potent antiviral activity against other
human coronaviruses, enabling the potential for a pan-coronavirus
treatment, including possibly coronaviruses that may infect human
populations in the future.
About Enanta Pharmaceuticals, Inc.
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
programs include clinical candidates currently in development for
the following disease targets: respiratory syncytial virus (RSV),
SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). 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
This press release contains forward-looking statements,
including statements with respect to the prospects for advancement
of EDP-235 for 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 impact of development,
regulatory and marketing efforts of others with respect to
competitive treatments for COVID-19; the discovery and development
risks of Enanta’s program for COVID-19; the competitive impact of
development, regulatory and marketing efforts of others in this
disease; any continuing impact of the COVID-19 pandemic on business
operations and clinical trials; Enanta’s lack of clinical
development experience; Enanta’s need to attract and retain senior
management and key research and development 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 Form 10-Q for the fiscal
quarter ended December 31, 2021, and any 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/20220329005158/en/
Media and Investor Contact: Jennifer Viera 617-744-3848
jviera@enanta.com
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