Enanta Pharmaceuticals Announces Topline Results Showing EDP-938 Achieved its Primary & Secondary Endpoints in its Phase 2a H...
June 14 2019 - 6:00AM
Business Wire
- EDP-938 achieved highly statistically
significant (p<0.001) reductions in viral load and in resolution
of clinical symptoms compared to placebo
- Conference call and webcast to discuss
the data at 8:30 a.m. ET today
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 topline results that demonstrated that EDP-938 achieved
highly statistically significant (p<0.001) reductions in viral
load and in resolution of clinical symptoms compared to placebo in
its Phase 2a human challenge study of EDP-938 in healthy adults
infected with respiratory syncytial virus (RSV).
“RSV is a serious unmet medical need with no therapeutic
treatment currently available,” stated Jay R. Luly, Ph.D.,
President and Chief Executive Officer. “Based on today’s positive
data for EDP-938, the only N-inhibitor in clinical development, our
goal is to initiate our first Phase 2b study by the end of calendar
2019 in adult outpatients with confirmed RSV infections.”
EDP-938 Phase 2a Challenge Study Topline ResultsThe Phase
2a study was a randomized, double-blind, placebo-controlled, human
challenge study in healthy adult subjects inoculated with RSV.
Subjects were randomized into 1 of 2 dosing arms or a placebo
arm and received either a once-daily (QD) 600 mg dose, a single 500
mg loading dose (LD) followed by a 300 mg twice daily (BID) dose,
or placebo for 5 days.
A total of 115 subjects were enrolled and inoculated with the
challenge virus. Once RSV infection was confirmed, participants
were then randomized: 38 in the placebo arm, 39 in the 600 mg QD
arm (one subject was randomized, but never dosed), and 38 in the
500mg LD plus 300mg BID arm.
A highly statistically significant reduction was observed for
the primary efficacy endpoint, the area under the curve (AUC) for
viral load in the intent-to-treat-infected population (ITT-I: all
randomized subjects receiving challenge virus and at least one dose
of study drug with confirmed RSV infection) for each of the EDP-938
dosing groups as compared with placebo. Specifically, EDP-938
lowered viral load AUC to 203.95 ± 173.50 hours x Log10 copies/mL
in the QD arm and 217.71 ± 217.55 hours x Log10 copies/mL in the
BID arm, compared to 790.15 ± 408.80 hours x Log10 copies/mL in the
placebo arm (p<0.001 for each of the EDP-938 groups compared to
placebo). There was no statistically significant difference between
the two EDP-938 dosing groups.
For the key secondary efficacy endpoint, the AUC for total
symptom score (TSS), a highly statistically significant reduction
was observed in the ITT-I population for each of the EDP-938 dosing
groups (124.47 hours x score ± 115.60 for the QD arm and 181.75 ±
248.42 hours x score for the BID arm, compared to 478.75 ± 422.29
hours x score in the placebo arm (p<0.001 for each of the
EDP-938 groups compared to placebo). There was no statistically
significant difference between the two EDP-938 dosing groups.
EDP-938 demonstrated good pharmacokinetics, and mean trough
levels of drug were maintained at approximately 20-40x above the in
vitro EC90 for RSV-infected human cells.
Overall, EDP-938 was generally safe and well tolerated. EDP-938
demonstrated a favorable safety profile over 5 days of dosing
through Day 28 of follow-up, comparable to placebo for both dosing
groups. There were no serious adverse events and no discontinuation
of study drug.
The study will be presented at a future medical conference.
Conference Call and Webcast InformationEnanta will host a
conference call and webcast today at 8:30 a.m. ET. To participate
in the live conference call, please dial (855) 840-0595 in the U.S.
or (518) 444-4814 for international callers. A replay of the
conference call will be available starting at approximately 11:30
a.m. ET on June 14, 2019, through 11:59 p.m. ET on June 16, 2019 by
dialing (855) 859-2056 from the U.S. or (404) 537-3406 for
international callers. The passcode for both the live call and the
replay is 1274559. A live audio webcast of the call and replay can
be accessed by visiting the “Events and Presentation” section on
the “Investors” page of Enanta’s website at www.enanta.com.
About EDP-938EDP-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 VirusRespiratory 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 EnantaEnanta Pharmaceuticals 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 DisclaimerThis 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 March 31, 2019 and 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/20190614005029/en/
Investor ContactCarol
Miceli617-607-0710cmiceli@enanta.comMedia Contact:Kari
WatsonMacDougall Biomedical
Communications781-235-3060kwatson@macbiocom.com
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