Enanta Initiates Phase 1 Study on EDP-322, an Oral Antibiotic With Activity Against Hospital- and Community-Acquired MRSA 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 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

SOURCE Enanta Pharmaceuticals

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