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Enanta Initiates Phase 1 Study on EDP-322, an Oral Antibiotic With Activity Against Hospital- and Community-Acquired MRSA
Date:9/15/2008

EDP-322 is a First-in-class MRSA-active Bicyclolide, a novel

macrolide-related drug class

WATERTOWN, Mass., Sept. 15 /PRNewswire/ -- Enanta Pharmaceuticals, a leader in the development of small molecule anti-infective drugs, announced today the initiation of a Phase 1 study on investigational oral antibiotic EDP-322, a first-in-class MRSA-active Bicyclolide, a novel macrolide-related drug class with a distinct resistance profile. The clinical development program for EDP-322 will include the treatment of hospital- and community-acquired gram-positive infections, including methicillin-resistant Staphylococcus aureus (MRSA). Preclinically, EDP-322 has demonstrated strong in vitro activity against hospital-acquired MRSA strains resistant to vancomycin, Zyvox(R) (linezolid), and CUBICIN(R) (daptomycin).

"Macrolides have been commonly prescribed to treat community infections for decades due to their convenient oral dosing and favorable safety profile," said Robert Moellering, M.D., a professor of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center. "Now with the discovery of a new generation of macrolides having high potency against hospital-acquired pathogens and a distinct resistance profile relative to other hospital antibiotics, there is a tremendous new opportunity to explore their use within not only the community, but the hospital setting as well."

"In our in vitro studies, EDP-322 demonstrated good potency against both hospital- and community-acquired MRSA, even against highly drug-resistant MRSA strains," explained Yat Sun Or, Ph.D., Senior Vice President of Research and Development at Enanta. "The potency of EDP-322 against hospital-acquired MRSA, community-acquired MRSA, and other gram-positive pathogens, combined with the convenience of oral administration, has the potential to uniquely position EDP-322 among marketed MRSA drugs in both the hospital and community settings."

Phase 1a Study Design

The Phase 1a, double-blind, placebo controlled study for EDP-322 announced today is a single ascending dose trial in healthy volunteers.

About Enanta's Bicyclolide Research Program

Bicyclolides posses a reengineered back-bone structure of traditional macrolide antibiotics. The discovery of Bicyclolide effectiveness against MRSA and VRE infections is part of Enanta's broad antibiotic research program. Enanta has applied several research strategies to develop these new classes of antibiotics, including innovative medicinal chemistry approaches to create novel and proprietary chemical structures. Enanta has applied its chemistry approach to create a promising pipeline of anti-infective drugs and a vast intellectual property estate.

About MRSA

More than 130,000 people each year need hospital care for MRSA infections, according to the Centers for Disease Control and Prevention. Staphylococcus aureus is a bacterium that can live harmlessly on human skin and is found in the nose of 20 to 40 percent of healthy individuals, but can sometimes cause infections when exposed to broken skin. MRSA is a particular type of the bacteria that has developed resistance to many antibiotics, including methicillin, making it difficult to treat.

About Enanta

Enanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best in class small molecule drugs in the anti-infective field. At the heart of Enanta is its commitment to innovative chemistry that surpasses traditional medicinal chemistry approaches. Enanta is developing novel protease, polymerase, and cyclophilin-based inhibitors targeted against the Hepatitis C virus (HCV). Additionally, the Company has created a new class of macrolide antibiotics, called Bicyclolides, which overcomes bacterial resistance. Antibacterial focus areas include superbugs, respiratory tract infections, and intravenous and oral treatments for hospital and community MRSA. Enanta is a privately held company with offices in Watertown, MA. More information about the company can be found at http://www.enanta.com.

Zyvox is a registered trademark of Pfizer Inc. and CUBICIN is a registered trademark of Cubist Pharmaceuticals, Inc.

Enanta Contacts

For Enanta Investor Relations, please contact:

Paul Mellett

617-607-0761

For Enanta Public Relations, please contact MacDougall Biomedical Communications:

Kari Watson

781-235-3060

kwatson@macbiocom.com


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SOURCE Enanta Pharmaceuticals
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