Enanta Provides Update on Clinical Development Activities During COVID-19 Pandemic
March 26 2020 - 4:05PM
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 an update
on its clinical trial activities in response to the COVID-19
pandemic. In order to ensure the safety of clinical trial
participants, and also in accordance with the recently issued
guidance documents of the U.S. Food and Drug Administration,
European Medicines Agency and Medicines and Healthcare products
Regulatory Agency, Enanta is making adjustments to some of its
ongoing clinical studies.
“The COVID-19 pandemic represents a significant, ongoing public
health threat and has created an unprecedented burden on healthcare
systems across the globe. With the safety of our clinical trial
participants in mind, coupled with a desire to alleviate many of
the resource constraints at clinical trial sites, Enanta has
proactively decided to make adjustments to some of our clinical
programs,” said Jay R. Luly, President and Chief Executive Officer
of Enanta. “While we were poised to begin dosing the ARGON-2 Phase
2b NASH study this week, we have paused recruitment and dosing in
this study, and we are pausing further recruitment in Part 2 of our
Phase 1a/1b study of EDP-514 in nuc-suppressed hepatitis B (HBV)
patients, which initiated earlier this quarter.”
Dr. Luly added, “As planned, we are continuing to prepare to
initiate our two Phase 2 respiratory syncytial virus (RSV) studies
of EDP-938 in pediatric and transplant patients later this year. We
also are hopeful we will be able to conduct our Phase 1b study of
EDP-514 in viremic HBV patients, as well as our first-in-human
study of EDP-297 for NASH, substantially on schedule. Further, we
have already completed the RSV season in the U.S. and are
continuing with plans to shift our RSVP study to the Southern
Hemisphere. We do not anticipate any supply disruption for any of
these trials. All of our plans are subject to change, though, as
the COVID-19 pandemic rapidly evolves, but fortunately we have
sufficient cash resources to bridge us across the current COVID-19
disruption. Meanwhile, in the coming weeks we plan to announce data
from our INTREPID study of EDP-305 in patients with primary biliary
cholangitis.”
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), non-alcoholic
steatohepatitis (NASH)/ primary biliary cholangitis (PBC),
hepatitis B virus (HBV), human metapneumovirus (hMPV) and emerging
coronaviruses.
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 and now marketed by AbbVie as part of its
leading treatment for chronic HCV infection, is sold under the
brand names 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 impact of COVID-19 on
Enanta’s clinical development programs. 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 the rapidly evolving COVID-19 pandemic on clinical study
participants and clinical trial sites and their healthcare
personnel involved in Enanta’s ongoing clinical trials and those
that would be expected to become involved in its planned clinical
trials; the uncertain extent of government actions taken to date
and any additional actions that may be taken in the future and
their impact on Enanta’s clinical trial activities; competition for
scarce healthcare resources that may need to be dedicated to the
COVID-19 pandemic rather than clinical trials; and other risk
factors described or referred to in “Risk Factors” in Enanta’s most
recent Form 10-Q for the fiscal quarter ended December 31, 2019 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/20200326005670/en/
Jennifer Viera 617-744-3848 jviera@enanta.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
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