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.
Copyright Business Wire 2014