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TMCNet:  Enanta Pharmaceuticals Initiates Phase 1 Study of MRSA Infection Candidate EDP-788

[January 13, 2014]

Enanta Pharmaceuticals Initiates Phase 1 Study of MRSA Infection Candidate EDP-788

WATERTOWN, Mass. --(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.


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