Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-323, its Oral, L-Protein Inhibitor in Development for the Treatment of Respiratory Syncytial Virus
April 06 2023 - 7:00AM
Business Wire
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage
biotechnology company dedicated to creating small molecule drugs
for viral infections, today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for
EDP-323, Enanta’s L-protein inhibitor in development for the
treatment of respiratory syncytial virus (RSV).
"Receiving Fast Track designation from the FDA underscores
EDP-323’s potential as a once-daily, oral therapeutic for the
treatment of this deadly virus and reflects the pressing need for a
highly potent, direct antiviral to treat RSV, particularly for
high-risk populations,” said Scott T. Rottinghaus, M.D., Senior
Vice President and Chief Medical Officer of Enanta Pharmaceuticals.
“Given that EDP-323 has shown sub-nanomolar potency against several
RSV-A and RSV-B strains in vitro and is not expected to have
cross-resistance to other classes of inhibitors, we believe it
could be used as a monotherapy or in combination with other RSV
mechanisms to potentially broaden the addressable RSV patient
populations or the treatment window. We believe this designation
will be a valuable component of our clinical and regulatory
strategy as we progress EDP-323 in development.”
The Fast Track program is designed to accelerate the development
and review of products such as EDP-323, 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.
EDP-323 is being evaluated in a Phase 1 double-blind,
placebo-controlled study designed to assess its safety,
tolerability, and pharmacokinetics (PK). Enanta plans to present
new preclinical PK data at the European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID) in April and expects
to report topline data from the Phase 1 study this quarter.
EDP-323 is supported by in vitro data demonstrating a
significant reduction in RSV replication with picomolar potency in
primary human bronchial epithelial cells against RSV A and B, with
consistent potency across a range of RSV clinical isolates in
various cell types. In a mouse model of RSV infection, EDP-323
treatment was associated with dose-dependent decreases in viral
load in the lung, reduced lung immunopathology and decreases in
pro-inflammatory cytokines, including IFNγ, TNFα, and IL1β.
Additionally, EDP-323 has favorable oral bioavailability with good
plasma exposures across preclinical species and pharmacokinetic
properties supporting once-daily, oral dosing in humans. These data
indicate that EDP-323 is a potent inhibitor of RSV replication and
has the potential to be a best-in-class, once daily, oral antiviral
treatment for RSV.
About Respiratory Syncytial Virus RSV is the most common
cause of bronchiolitis (inflammation of the small airways in the
lung) and pneumonia in children under one year of age in the United
States and a significant cause of respiratory illness in older
adults and immunocompromised individuals.1 According to the Centers
for Disease Control and Prevention, virtually all children in the
United States get an RSV infection by the time they are two years
old and one to two out of every 100 children younger than six
months of age with an RSV infection may need to be hospitalized.2
Globally, there are an estimated 33 million cases of RSV annually
in children less than five years of age, with about 3 million
hospitalized and up to approximately 120,000 dying each year from
complications associated with the infection.3 RSV represents a
significant health threat for adults older than 65 years of age,
with an estimated 177,000 hospitalizations and 14,000 deaths
associated with RSV infections annually in the United States.4
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. Enanta’s
research and development programs include clinical candidates for
the following disease targets: respiratory syncytial virus (RSV),
SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also
conducting research on a single agent targeting both RSV and 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 EDP-323 for RSV. 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 RSV; the discovery and
development risks of Enanta’s RSV program ; the competitive impact
of development, regulatory and marketing efforts of others in this
disease; any continuing impact of the COVID-19 pandemic on
incidence of RSV; 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-K for the fiscal year ended September
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.
1. Centers for Disease Control & Prevention – Respiratory
Syncytial Virus 2. Centers for Disease Control & Prevention –
RSV in Infants and Young Children 3. Shi et al. Global, regional,
and national disease burden estimates of acute lower respiratory
infections due to respiratory syncytial virus in young children in
2015: a systematic review and modelling study. Lancet. 2017 Sep 2;
390(10098): 946–958: 4. Falsey AR, et al. Respiratory syncytial
virus infection in elderly and high-risk adults. New Engl J Med.
2005;352(17):1749-59.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230406005158/en/
Media and Investors: Jennifer Viera 617-744-3848
jviera@enanta.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Jul 2024 to Aug 2024
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Aug 2023 to Aug 2024