-
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
WATERTOWN, Mass.–(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
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 Results
The 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 Information
Enanta 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-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 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 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 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.
Contacts
Investor Contact
Carol Miceli
617-607-0710
cmiceli@enanta.com
Media
Contact:
Kari Watson
MacDougall Biomedical Communications
781-235-3060
kwatson@macbiocom.com