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)
"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
"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.
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.
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.
For Enanta Investor Relations, please contact:
For Enanta Public Relations, please contact MacDougall Biomedical
SOURCE Enanta Pharmaceuticals