New Data from Enanta’s Phase 2a Human Challenge Study of EDP-938 for RSV Demonstrates Highly Statistically Significant Redu...
October 03 2019 - 7:30AM
Business Wire
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases, today
announced that new data from its Phase 2a Human Challenge Study of
EDP-938 is being presented as a late-breaker oral presentation
today at IDWeek™ 2019 in Washington, D.C. EDP-938 is Enanta’s lead
N-protein inhibitor being developed for the treatment of RSV
infection.
Today’s late-breaking oral presentation will include data
demonstrating that in the RSV Challenge study EDP-938 administered
once or twice daily achieved highly statistically significant
reductions (p<0.001) in RSV viral load by quantitative viral
culture (plaque assay), as well as in mucus production. These data
were consistent with the data for the primary efficacy endpoint of
RSV viral load reduction by RT-PCR, as well as the secondary
endpoint of reduction in RSV-associated total symptom score, both
of which endpoints have been reported previously.
The results of the RSV quantitative viral culture assay (Log10
plaque forming units/mL) demonstrated highly statistically
significant (p<0.001) reductions in RSV viral load area under
the curve (AUC) of 82.53% and 77.43%, in the QD and BID arms,
respectively, compared to the placebo arm and without a significant
difference between the dosing groups. These findings confirm the
previously reported, highly statistically significant (p<0.001)
reductions in RSV viral load AUC by quantitative RT-PCR in the QD
and BID arms of 74.43% and 71.46%, respectively, compared to
placebo and without a significant difference between the dosing
groups. Additionally, highly statistically significant reductions
(p<0.001) in RSV-associated nasal mucus production (mucus
weight) of 72.06% and 77.67% in the QD and BID arms, respectively,
compared to placebo and without a significant difference between
the dosing groups.
These data support the further clinical evaluation of EDP-938.
Enanta plans to initiate a Phase 2b clinical study of EDP-938 in
adult out-patients with RSV by the end of 2019.
The double-blind, placebo-controlled, Phase 2a study being
presented evaluated EDP-938 in adult volunteers inoculated with
RSV-A Memphis 37b. EDP-938 was dosed for 5 days as 600mg once daily
(QD arm) or a 500mg loading dose then 300mg twice daily (BID arm),
or study subjects received placebo. A total of 115 subjects were
randomized and inoculated; 86 were included in the analysis of the
intent-to-treat-infected (ITT-I) population, which comprised all
randomized and inoculated subjects who received at least one dose
of study drug and who had confirmed RSV infection.
EDP-938 Presentations at IDWeek™ 2019 are listed below:
Late-Breaker Oral Presentation: October 3, 2019 Time:
2:35 – 2:45 pm ET #LB6: “EDP-938, a Novel RSV N-Inhibitor,
Administered Once or Twice Daily Was Safe and Demonstrated Robust
Antiviral and Clinical Efficacy in a Healthy Volunteer Challenge
Study”, Coakley, et.al.
Poster Presentation: October 3, 2019 12:15 – 1:30 pm ET
#667: “Preclinical Pharmacokinetic and Pharmacodynamic
Characterization of EDP-938, a Novel and Potent Non-Fusion
Replication Inhibitor of Respiratory Syncytial Virus,” Jiang,
et.al.
These abstracts and further information about IDWeek™ 2019 can
be found at:
https://www.idsociety.org/events2/events/2019/October/idweek-2019/.
About EDP-938 EDP-938, Enanta’s lead N-protein inhibitor,
is being developed for the treatment of RSV infection. Enanta
believes EDP-938 is differentiated from fusion inhibitors currently
in development by others for RSV because this N-protein inhibitor
targets the virus’ replication machinery and has demonstrated high
barriers to resistance against the virus in vitro. EDP-938 has also
been shown to reduce viral load below the level of detection in
vivo. Additionally, it is possible that N-protein inhibitors may be
effective treatments at later stages of infection.
About Respiratory Syncytial Virus Respiratory syncytial
virus (RSV) is a virus that infects the lungs and represents a
serious unmet medical need in infants and children. RSV is the most
common cause of bronchiolitis (inflammation of the small airways in
the lung) and pneumonia in children under 1 year of age in the
United States. Also, at increased risk of a severe RSV infection
are children with compromised (weakened) immune systems due to a
medical condition or medical treatment, adults with compromised
immune systems and those age 65 and older. Recent estimates suggest
that approximately 200,000 hospitalizations in the U.S. and EU
occur each year in children under the age of two and approximately
170,000 hospitalizations in these regions occur in each year in
adults aged 65 and older. There is currently no safe and effective
therapy for already established RSV infection.
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 are currently focused on the following disease
targets: respiratory syncytial virus (RSV), non-alcoholic
steatohepatitis (NASH)/ primary biliary cholangitis (PBC), and
hepatitis B virus (HBV).
Enanta’s research and development activities are funded by
royalties from HCV products developed under its collaboration with
AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is
now sold by AbbVie in numerous countries as part of its newest
treatment for chronic hepatitis C virus (HCV) infection. This
leading HCV regimen is sold 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 with respect to
EDP-938 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 development risks of early stage discovery
efforts in the disease areas in Enanta’s research and development
pipeline, such as RSV; the impact of development, regulatory and
marketing efforts of others with respect to competitive treatments
for RSV; 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 fiscal quarter ended June 30, 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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Investor Contact Carol Miceli 617-607-0710
cmiceli@enanta.com Media Contact Kari Watson MacDougall
Biomedical Communications 781-235-3060 kwatson@macbiocom.com
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