Enanta Pharmaceuticals Initiates a Phase 2b Clinical Study of EDP-938 in High-Risk Adults with Respiratory Syncytial Virus
October 03 2022 - 7:00AM
Business Wire
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage
biotechnology company dedicated to creating small molecule drugs
for viral infections and liver diseases, today announced the
initiation of a Phase 2b, randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of
EDP-938, its novel N-protein inhibitor, in adults with acute
respiratory syncytial virus (RSV) infection who are at high risk of
complications, including the elderly and/or those with congestive
heart failure, chronic obstructive pulmonary disease (COPD) or
asthma.
“We are excited to expand our RSV program with the progression
of EDP-938 into another trial of high-risk patients, where we
believe that treatment with our compound has the greatest potential
to show optimal efficacy and clinical benefit,” commented Jay R.
Luly, Ph.D., President and Chief Executive Officer of Enanta
Pharmaceuticals. “We are eager to advance our broad clinical
development plan that is focused on evaluating EDP-938 in these
patients that have the greatest unmet need, continuing with our
strategy of targeting populations at high-risk for RSV. In previous
clinical studies, EDP-938 significantly improved the percentage of
people with undetectable RSV RNA at the end of treatment,
consistent with inhibiting viral replication. Additionally, EDP-938
has a favorable and consistent safety profile in approximately 500
people exposed to date. As we progress this study and advance our
pipeline, we look forward to continuing to build our leadership
position in this disease area.”
The Phase 2b, randomized, double-blind, placebo-controlled,
multi-center, global study is designed to evaluate the effect of
EDP-938 compared with placebo on the progression of RSV infection
by assessment of clinical symptoms. Approximately 180 patients will
be treated with 800 mg of EDP-938 or placebo for 5 days and
evaluated for 28 days thereafter. The study will include
non-hospitalized adult subjects with up to 72 hours of respiratory
tract infection symptoms who test positive for RSV and negative for
influenza virus and SARS-CoV-2. Patients will be considered high
risk for complications after RSV infection if they have at least
one of the following risk factors: age 65 years or older,
congestive heart failure, COPD or asthma. The primary endpoint of
the study is time to resolution of RSV lower respiratory tract
disease symptoms as assessed by the Respiratory Infection Intensity
and Impact Questionnaire (RiiQ™) symptom scale through Day 33.
Secondary endpoints include additional clinical efficacy measures
and antiviral activity compared to placebo, pharmacokinetics, and
safety of EDP-938.
About EDP-938 EDP-938, Enanta’s lead N-protein inhibitor,
is being developed for the treatment of RSV infection, and has been
granted Fast Track designation by the U.S. Food and Drug
Administration. EDP-938 is a nanomolar inhibitor of both RSV-A and
RSV-B activity. EDP-938 is differentiated from RSV fusion
inhibitors as the N-protein inhibitor targets the virus’
replication machinery and has demonstrated a high barrier to
resistance in vitro. In preclinical studies, EDP-938 maintained
antiviral potency across all clinical isolates tested and was
active against viral variants resistant to other mechanisms.
EDP-938 demonstrated a favorable safety, pharmacokinetic and
drug-drug interaction profile in an extensive Phase 1 program. In a
Phase 2 challenge study, EDP-938 achieved highly statistically
significant (p<0.001) reductions in RSV viral load and clinical
symptoms compared to placebo and was safe and well-tolerated, with
infrequent adverse events. EDP-938 is currently being evaluated in
RSVPEDs, a Phase 2 study in pediatric RSV patients, RSVTx, a Phase
2b study in adult hematopoietic cell transplant recipients with
RSV, and RSVHR, a Phase 2b study in the elderly and/or those with
congestive heart failure, chronic obstructive pulmonary disease
(COPD) or asthma.
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 U.S.
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 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 and liver
diseases. Enanta’s research and development programs include
clinical candidates currently in development for the following
disease targets: respiratory syncytial virus (RSV), SARS-CoV-2
(COVID-19) and hepatitis B virus (HBV). Enanta is also conducting
research in 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.
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.
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Media and Investor Jennifer Viera 617-744-3848
jviera@enanta.com
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