Enanta Pharmaceuticals to Provide Updates on its Research & Development Programs & Outlook for 2021 at the 39th Annual J.P. M...
January 08 2021 - 7:01AM
Business Wire
- Announces New Oral HBV RNA Destabilizer, EDP-721, as an
Additional Component Toward Functional HBV Cure; Expects to
Initiate Phase 1 Study Mid-2021
- Expands RSV Program with Introduction of Discovery Initiative
for RSV L-Inhibitors
- Initiated RSVTx, a Phase 2b Study of EDP-938 in Adult
Hematopoietic Cell Transplant Recipients with Acute RSV
Infection
- Strong Cash Balance of $419 Million at September 30, 2020
Supports Expanding Research and Development Programs
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage
biotechnology company dedicated to creating small molecule drugs
for viral infections and liver diseases, today announced that Jay
R. Luly, Ph.D., Enanta’s President and Chief Executive Officer,
will provide an update across its pipeline programs in virology and
non-alcoholic steatohepatitis (NASH), including its newest
candidate, EDP-721, a novel oral hepatitis B virus (HBV) RNA
destabilizer and the expansion of its respiratory syncytial virus
(RSV) platform with a new RSV-L inhibitor program, as well as
provide an update on its plans for 2021 during Enanta’s
presentation at the 39th Annual J.P. Morgan Healthcare Conference
on January 12, 2021 at 8:20 a.m. ET.
“Throughout 2020, Enanta made meaningful progress with the
initiation of five clinical trials across our pipeline. We look
forward to building on this momentum in 2021, starting with the
introduction today of our newest HBV clinical candidate, EDP-721, a
novel RNA destabilizer with the potential to reduce the production
of multiple HBV proteins, which we believe could be a key component
in achieving a functional cure in this indication,” stated Jay R.
Luly, President and Chief Executive Officer of Enanta
Pharmaceuticals. “Robust pre-clinical data has demonstrated that
EDP-721 has the potential to reduce HBsAg production with HBV
pan-genomic activity and exhibits additive to synergistic activity
with approved nucleoside therapies and with Enanta’s HBV core
inhibitor, EDP-514. These data give us the confidence to progress
EDP-721 into a Phase 1 clinical study by mid-2021, bringing us one
step closer to developing an all-oral, triple regimen that could be
a functional cure for patients living with chronic HBV.”
“We are also excited about the expansion of our RSV program,
highlighted by our new discovery of potent RSV L-inhibitors. We
look forward to continuing our progress throughout 2021 with
multiple milestones expected across our pipeline, including the
initiation of our Phase 2 study of EDP-938 in pediatric patients
with RSV this quarter, preliminary data from two Phase 1b studies
of EDP-514 in HBV in the second quarter, and results from our Phase
1 study of EDP-297 in development for the treatment of NASH, also
in the second quarter. Furthermore, we expect to have preliminary
information from an initial interim analysis of our Phase 2b NASH
study of EDP-305 around mid-year, which we will use to help with
further internal assessment of our NASH program,” continued Dr.
Luly. “Overall, 2021 is shaping up to be an exciting,
catalyst-heavy year for Enanta, and we believe we are
well-positioned to extend our track record of success heading into
the new year.”
During the presentation, Dr. Luly will discuss Enanta’s pipeline
program updates and expectations for 2021.
Pipeline Programs Update and Review
Virology
Hepatitis B Virus
- EDP-721, Enanta’s newest clinical candidate, is a potent and
selective HBV RNA destabilizer, which has demonstrated a robust
reduction of viral transcripts in preclinical models, leading to
reduced production of multiple HBV proteins, including HBV surface
antigen (HBsAg) and e-antigen (HBeAg). By targeting HBV RNA,
EDP-721 is expected to reduce HBsAg derived from both integrated
and covalently-closed circular DNA (cccDNA). Since high levels of
HBsAg are known to suppress innate and adaptive immune responses,
which are believed to occur through multiple mechanisms, a
sustained reduction of HBsAg is regarded as a key component of a
functional cure for HBV. Enanta plans to develop EDP-721 for use
alone or in combination with other mechanisms, such as EDP-514,
with the ultimate goal of achieving a functional cure. Enanta
expects to initiate a Phase 1 clinical study of EDP-721 in
mid-2021.
- EDP-514, Enanta’s core inhibitor with Fast Track Designation
from the FDA, is being developed in two Phase 1b studies for the
treatment of HBV across different patient populations: subjects on
treatment with a nucleos(t)ide reverse transcriptase inhibitor
(NUC-suppressed patients), and chronic HBV subjects with high viral
loads who are not currently on therapy (viremic patients).
Preliminary data is expected for both trials in the second quarter
of 2021.
Respiratory Syncytial Virus
- EDP-938, Enanta’s N-protein inhibitor with Fast Track
Designation from the FDA, is being evaluated in a broad clinical
development program, consisting of three trials.
- In December, Enanta initiated RSVTx, a Phase 2b, randomized,
double-blind, placebo-controlled, multicenter study evaluating the
efficacy and safety of EDP-938 in adult hematopoietic cell
transplant recipients with acute RSV infection and symptoms of
upper respiratory tract infection. The company plans to enroll,
within 72 hours of symptom onset, approximately 200 adult subjects
18 to 75 years of age, who will receive EDP-938 or placebo for 21
days. The primary endpoint is the incidence of lower respiratory
tract complications within 28 days of enrollment, while secondary
endpoints include change from baseline in RSV RNA viral load,
safety and pharmacokinetics.
- RSVP, a Phase 2b randomized, double-blind, placebo-controlled
study in 70 adult outpatients with community-acquired RSV
infection, is ongoing, but to date the 2021 RSV season in the
Northern Hemisphere has not yet begun due to COVID-19 mitigation
measures. Enanta has made extensive efforts to expand its clinical
sites beyond North America, including sites across the EU and
Asia-Pacific, to be ready when RSV infection arrives. The company
will provide further guidance on trial completion once RSV becomes
prevalent again.
- RSVPEDs, a Phase 2 randomized, double-blind, placebo-controlled
study in hospitalized and non-hospitalized pediatric RSV patients
age 28 days to 24 months, is expected to initiate in early
2021.
Virology Discovery Programs – In 2021, Enanta anticipates
identifying development candidates for two of its three virology
discovery programs listed below:
Respiratory Syncytial Virus
- The RSV L-protein is a viral RNA-dependent RNA polymerase that
contains multiple enzyme activities required for RSV replication.
Today, Enanta announced the expansion of its RSV program with the
introduction of an RSV L-inhibitor discovery initiative that
includes potent nanomolar leads active against both RSV-A and
RSV-B. An RSV-L-inhibitor is not expected to have cross-resistance
to other classes of inhibitors, and therefore can potentially be
used alone or in combination with agents targeting other RSV
mechanisms, such as EDP-938.
Human Metapneumovirus (hMPV)
- Enanta is developing nanomolar inhibitors of human
metapneumovirus, a pathogen that causes upper and lower respiratory
tract infections in young children and the elderly, as well as in
immunocompromised patients or those with COPD or asthma.
SARS-CoV-2
- Enanta is working to discover direct-acting antiviral drug
candidates for patients infected with the novel coronavirus,
SARS-CoV-2, using a combination of drug target screening and drug
design. The company is focused on polymerase and protease
inhibitors and is currently optimizing potent lead molecules.
Non-Alcoholic
Steatohepatitis
- EDP-305, Enanta's lead farnesoid X receptor (FXR) agonist with
Fast Track Designation from the FDA, is currently being evaluated
in ARGON-2, a Phase 2b randomized, double-blind, placebo-controlled
72-week study of approximately 340 patients with biopsy-confirmed
NASH with fibrosis, using doses of 1.5 mg and 2.0 mg. A 12-week
interim analysis on a subset of patients for the company’s internal
assessment is planned for mid-year 2021.
- EDP-297, Enanta’s highly potent and targeted follow-on FXR
agonist also being developed for the treatment of NASH with
fibrosis, is currently being evaluated in an ongoing Phase 1
randomized, double-blind, placebo-controlled, first-in-human
clinical trial. Enanta expects to report safety, tolerability and
pharmacokinetics data in the second quarter of 2021.
- Enanta plans to use the results of the Phase 1 study of EDP-297
and the 12-week interim analysis in ARGON-2 to prioritize both FXR
agonist compounds and seek opportunities for development of one or
both of them in combination with other mechanisms for NASH with
fibrosis.
Webcast Information Enanta’s presentation will take place
on January 12, 2021 at 8:20 a.m. ET. A live webcast of the
presentation, as well as the question and answer breakout session
that follows the presentation, will be accessible by visiting the
“Events and Presentations” section on the “Investors” page of
Enanta’s website at www.enanta.com. A replay of the webcasts will
be available following the presentation and will be archived for
approximately 60 days.
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 efforts have produced
clinical candidates for the following disease targets: respiratory
syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic
steatohepatitis (NASH). Enanta is also conducting research in human
metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).
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 sold by AbbVie in numerous countries as
part of its leading treatment for chronic HCV infection under the
tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.)
(glecaprevir/pibrentasvir). Please visit www.enanta.com for more
information.
FORWARD LOOKING STATEMENTS This press release contains
forward-looking statements, including statements with respect to
the prospects for advancement of Enanta’s clinical programs in RSV,
HBV and NASH, as well as its discovery programs in SARS-CoV-2 and
hMPV. 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 impact of development, regulatory and
marketing efforts of others with respect to competitive treatments
for RSV, HBV, NASH, SARS-CoV-2 and hMPV; the discovery and
development risks of Enanta’s programs in RSV, HBV, NASH,
SARS-CoV-2 and hMPV; the competitive impact of development,
regulatory and marketing efforts of others in those disease areas;
any continuing impact of the COVID-19 pandemic on business
operations and clinical trials; Enanta’s lack of clinical
development experience; Enanta’s need to attract and retain senior
management and key research and development 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-K for
the fiscal year ended September 30, 2020, 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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version on businesswire.com: https://www.businesswire.com/news/home/20210108005105/en/
Investor and Media Contact: Jennifer Viera 617-744-3848
jviera@enanta.com
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