Enanta Pharmaceuticals Initiates Phase 1 Study of MRSA Infection Candidate EDP-788
January 13 2014 - 7:30AM
Business Wire
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA) a research and
development-focused biotechnology company dedicated to creating
small molecule drugs in the infectious disease field, today
announced the initiation of a Phase 1 clinical study of EDP-788,
Enanta’s investigational compound for MRSA (methicillin-resistant
Staphylococcus aureus) infections.
EDP-788 is being studied in a randomized double-blind,
placebo-controlled clinical study to evaluate the safety and
pharmacokinetics of a single oral dose of EDP-788 in up to 64
healthy volunteers.
“With the increased spread of MRSA, as well as other resistant
Gram-positive pathogens, there is an urgent need for the
development of new antibiotics that will be effective against
pathogens that are resistant to current antibiotics,” stated Jay R.
Luly, PhD., President and Chief Executive Officer.
Enanta has created a new class of antibiotics called
Bicyclolides. EDP-788, Enanta’s lead antibiotic candidate, is a
Bicyclolide developed by Enanta that has demonstrated a broad
spectrum of activity against many bacterial organisms, including
MRSA. This study, as well as all preclinical and early clinical
development of EDP-788, is funded under Enanta’s contract with the
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health.
About Bicyclolides and EDP-788
Bicyclolides are a new family of antibiotics created through
Enanta’s internal chemistry efforts. They have been designed to
overcome resistance and possess a significantly improved product
profile compared to existing macrolides. Enanta’s lead Bicyclolide
antibiotic product candidate is EDP-788, which is being developed
for use as an intravenous drug in the hospital setting and for oral
dosing in a home setting. EPD-788 is a pro-drug, which means it is
inactive until it is converted in the body into an active compound.
Due to its high water solubility, EDP-788 has the benefit of
allowing for an intravenous, or IV formulation, as well as oral
dosing in pill form.
About Enanta
Enanta Pharmaceuticals is a research and development-focused
biotechnology company that uses its robust chemistry-driven
approach and drug discovery capabilities to create small molecule
drugs in the infectious disease field. Enanta is discovering, and
in some cases developing, novel inhibitors designed for use against
the hepatitis C virus (HCV). These inhibitors include members of
the direct acting antiviral (DAA) inhibitor classes – protease
(partnered with AbbVie), NS5A (partnered with Novartis) and
nucleotide polymerase – as well as a host-targeted antiviral (HTA)
inhibitor class targeted against cyclophilin. Additionally, Enanta
has created a new class of antibiotics, called Bicyclolides, for
the treatment of multi-drug resistant bacteria, with a focus on
developing an intravenous and oral treatment for hospital and
community MRSA (methicillin-resistant Staphylococcus aureus)
infections.
FORWARD-LOOKING STATEMENTS DISCLAIMER
This press release contains forward-looking statements,
including statements with respect to the prospects for further
clinical development of EDP-788 and other Bicyclolides as treatment
s for MRSA and other infections. 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: Enanta’s reliance on NIAID
for funding of the preclinical and early clinical development of
EDP-788; regulatory actions affecting clinical development or
treatment regimens containing EDP-788 or any additional
Bicyclolide; clinical development of competitive product candidates
of others for MRSA and other bacteria; Enanta’s lack of clinical
development experience; Enanta’s need to attract and retain senior
management and key scientific personnel; Enanta’s lack of resources
and experience commercializing drugs; 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 and other periodic
reports filed 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.
Enanta Pharmaceuticals, Inc.Investor ContactCarol Miceli,
617-607-0710cmiceli@enanta.comorMacDougall Biomedical
CommunicationsKari Watson, 781-235-3060kwatson@macbiocom.com
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