Enanta Pharmaceuticals Presents New Preclinical Data for EDP-235, its Oral, Direct-Acting Antiviral Protease Inhibitor Specifically Designed for the Treatment of COVID-19 at IDWeek™ 2022
October 19 2022 - 8:00AM
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 new
preclinical data supporting the potential of EDP-235 for the
treatment of COVID-19, which are being presented at IDWeek 2022 in
Washington, DC.
New data presented continue to highlight EDP-235’s excellent
penetration into SARS-CoV-2 target tissues and cells including
macrophages and monocytes, suggesting it can possibly mitigate the
macrophage-mediated cytokine storm that can occur in high-risk
COVID-19 patients. Enanta is on schedule to begin a Phase 2 study
of EDP-235 this quarter.
“We are encouraged by the growing body of data suggesting that
EDP-235 is a differentiated, once-daily, oral antiviral for
COVID-19. In particular, these data presented show that EDP-235 has
the ability to penetrate into critical immune cells and eliminate
viral replication.” said Jay R. Luly, Ph.D., President and Chief
Executive Officer of Enanta Pharmaceuticals. “Taken together with
data from our Phase 1 study that demonstrated favorable safety,
tolerability, and pharmacokinetics with strong exposure multiples
over the EC90, EDP-235 is well positioned to potentially be a
best-in-class direct acting antiviral for COVID-19. We look forward
to continuing the clinical development of EDP-235.”
October 21, 2022, Oral Presentation
from 12:15 – 12:45 PM ET, Poster# 1123 Presentation from 12:15 –
1:30 PM ET
“EDP-235, A Potent and Once-Daily Oral Antiviral,
Demonstrates Excellent Penetration into Macrophages and Monocytes,
with the Potential for Mitigation of Cytokine Storm in High-Risk
COVID-19 Patients” Lisha Xu, United States
Intracellular uptake of EDP-235 compared to nirmatrelvir was
evaluated in rat lung alveolar macrophages (AM), human monocytes
and human macrophages. To determine the in vivo drug distribution
into lung AM, rats were dosed orally with 25 mg/kg of EDP-235 or
nirmatrelvir and plasma and AM drug levels were analyzed by liquid
chromatography-tandem mass spectrometry. The ratios of
intracellular to extracellular concentrations of EDP-235 in rat
lung AM, human monocytes and human macrophages were 23.6, 22.7 and
30.5, respectively, compared to ratios of 0.6, 1.5 and 1.2 for
nirmatrelvir in these cells. Consistent with the in vitro
observations, EDP-235 showed favorable rat AM penetration with an
AUC0-24 ratio of 28.4 (AM over plasma), and nirmatrelvir had less
rat AM penetration with an AUC0-24 ratio of 0.5 (AM over plasma).
EDP-235 had respective AUC0-24 values of 9.6 and 271.9 h·μg/mL in
rat plasma and AM, while the AUC0-24 values of nirmatrelvir in rat
plasma and AM were 2.7 and 1.2 h·μg/mL, respectively. These
preclinical data demonstrate that EDP-235 achieved excellent
penetration into monocytes and macrophages, including lung AM.
EDP-235 has the potential to eliminate viral replication of
SARS-CoV-2 in these critical immune cells, thus mitigating
macrophage-mediated cytokine storm in high-risk COVID-19
patients.
About Enanta Pharmaceuticals 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 part of one of the leading treatment
regimens for curing chronic HCV infection and is sold by AbbVie in
numerous countries 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 Enanta’s clinical programs in
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
COVID-19 program; the competitive impact of development, regulatory
and marketing efforts of others in this disease area; 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 June
30, 2022, 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/20221019005243/en/
Media and Investor Jennifer Viera 617-744-3848
jviera@enanta.com
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