Enanta Pharmaceuticals Announces Positive Phase 1 Results & Initiation of Phase 2a Clinical Study of EDP-938 for Respiratory ...
October 23 2018 - 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 dosing has begun in a Phase 2a study to evaluate the
safety, pharmacokinetics and antiviral activity of multiple doses
of orally administered EDP-938 against respiratory syncytial virus
infection in a human challenge study.
“RSV is an infection for which there is no safe and effective
treatment,” stated Jay R. Luly, Ph.D., President and CEO, Enanta.
“Infants, the elderly, and immune compromised individuals are at
the highest risk for this severe respiratory tract infection.
EDP-938 is the only N-protein inhibitor in development today and
represents a new approach by targeting viral replication of RSV. We
are pleased to announce the initiation of our Phase 2a challenge
study, and we are targeting preliminary Phase 2a results in
calendar 3Q19.”
EDP-938 Phase 2a DesignIn this randomized, double-blind,
placebo-controlled, human challenge study, up to 114 healthy adult
subjects will be randomized into 1 of 3 arms (1:1:1) and will be
dosed for 5 days. All subjects will be infected with RSV-A Memphis
37b virus, and approximately 76 subjects will receive EDP-938 and
38 subjects will receive placebo. Arm 1 will receive placebo, Arm 2
will receive a single 500 mg loading dose of EDP-938 followed by
300 mg BID, and Arm 3 will receive a daily 600 mg dose. Primary and
secondary outcome measures include changes in viral load
measurements and change of baseline symptoms.
EDP-938 Phase 1 ResultsDetails of this Phase 1 study will
be presented on November 1 at the 11th International Respiratory
Syncytial Virus Symposium in Asheville, North Carolina.
The Phase 1 randomized, double-blind, placebo (PBO)-controlled,
first-in-human study was conducted to evaluate the safety,
tolerability, and pharmacokinetics (PK) of single- and multiple- (7
days) ascending doses (SAD: 50 - 800 mg and MAD: 100 - 600 mg once
daily and 300 mg twice daily) and food effect (FE) of EDP-938 in
healthy subjects. In the SAD phase, 50 subjects [EDP-938 (n=38) and
PBO (n=12)] were enrolled into 6 dose cohorts; in the MAD phase, 40
subjects [EDP-938 (n=30) and PBO (n=10)] were enrolled into 5 dose
cohorts.
Overall, no safety concerns have been reported in 68 healthy
subjects receiving a broad range of single and multiple doses of
EDP-938. Headache was the most frequently reported AE during the
SAD and MAD phases. There were no SAEs, and AEs were of mild
intensity, with none leading to study drug discontinuation.
EDP-938 was rapidly absorbed and exposure increased with
increasing single and multiple dosing, resulting in a PK profile
suitable for once or twice daily oral dosing regardless of food. In
the MAD phase, half-life ranged from 12.9 to 17.6 hours, and at
doses comparable to those under study in the Phase 2a trial, mean
trough levels were approximately 30x higher than the EC90 of
EDP-938 against RSV-infected human cells.
Data at the 11th International Respiratory Syncytial Virus
Symposium in Asheville, North Carolina, October 31 to November 4,
2018:
- Poster PresentationNov. 1,
11:30 am to 12:30 pm ET, Nathalie Adda, MD“EDP-938, a Novel,
Non-Fusion Replication Inhibitor of Respiratory Syncytial Virus:
Preliminary Results of a Phase 1 Study in Healthy Subjects
(HS)”
- Oral PresentationNov. 2,
12:45 to 13:00 pm ET, Michael Rhodin, Ph.D.“EDP-938, a Novel
Non-Fusion Replication Inhibitor of RSV, Displays a High Barrier to
Resistance In Vitro”
About EDP-938EDP-938, Enanta’s lead non-fusion
N-inhibitor, is being developed for the treatment of RSV infection.
Enanta believes a non-fusion approach differentiates this compound
from fusion inhibitors currently in development for RSV because
non-fusion inhibitors target the virus’ replication machinery and
have 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, non-fusion inhibitors
have the potential of being effective at later stages of
infection.
About RSVRespiratory syncytial virus (RSV) is a virus
that infects the lungs and represents a serious unmet medical need
in infants and children, as well as immune-compromised individuals
and the elderly. 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. Each year,
57,000 to 125,000 children in this group are hospitalized due to
RSV infection. 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 65 and older. There is currently no
effective treatment available for treating 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.
Glecaprevir, a protease inhibitor discovered by Enanta, has been
developed by AbbVie, and is now approved in numerous countries, as
part of AbbVie’s 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).
Royalties from the AbbVie collaboration are helping to fund
Enanta’s research and development efforts, which are currently
focused on the following disease targets: non-alcoholic
steatohepatitis (NASH), primary biliary cholangitis (PBC),
respiratory syncytial virus (RSV) and hepatitis B virus (HBV).
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 EDP-938 and Enanta’s RSV program.
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 development
efforts in disease areas such as RSV; potential competition from
the development efforts of others in RSV; Enanta’s lack of 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 quarter ended
June 30, 2018 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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Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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