Enanta Pharmaceuticals Initiates Phase 1 Clinical Trial on EP-013420, a First-In-Class Bridged Bicyclic Ketolide Antibiotic for Community Respiratory Tract Infections

WATERTOWN, Mass. -- Enanta Pharmaceuticals announced that it has initiated a Phase 1 clinical trial in the United States for its community antibiotic candidate, EP-013420.

First in its class, EP-013420 is a bridged bicyclic ketolide (BBK) that was designed by Enanta to have optimal pharmacokinetics and to provide broad treatment against respiratory pathogens, including several multi-drug resistant strains for which traditional macrolides, penicillins, and fluoroquinolones are no longer effective. In this trial, EP-013420 will be evaluated for its pharmacokinetics, safety and tolerability in healthy volunteers. In July 2004, Enanta exclusively licensed the Asia territory rights for EP-013420 to Shionogi & Co., LTD., of Osaka, Japan.

"This clinical trial marks an important milestone for Enanta, as we have translated our chemistry and drug discovery expertise into a very important new clinical-stage product with blockbuster potential to satisfy a growing unmet medical need in the community setting," said Jay Luly, PhD, president and CEO. "The ambitious pre-clinical product-profile we have achieved with EP-013420 will provide us the opportunity to pursue multiple indications and position this drug candidate as best-in-class."

"There is a tremendous need for next generation antibiotics to overcome the growing threat of bacterial resistance in the treatment of community respiratory tract infections," stated infectious disease specialist Robert C. Moellering, Jr., MD, Herrman Blumgart professor of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center and Enanta clinical advisor.

"Enanta's novel BBK antibiotics offer the promise of broader coverage against many of these resistant strains with the potential of improved safety and efficacy, and more convenient dosing," said Yat Sun Or, Ph., senior vice president, research and development.

About EP-013420

Enanta is developing EP-013420 for the treatment of community respiratory tract infections with potential indications for community acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, tonsilitis/pharyngitis, and otitis media. EP-013420 is a first-in-class bridged bicyclic ketolide antibiotic that is the result of Enanta's innovative medicinal chemistry approach to creating novel and proprietary chemical structures. Preclinical studies have shown an excellent pharmacokinetic profile for EP-013420 and an improved activity profile relative to currently marketed macrolides and ketolides, including activity against many strains of resistant S. pneumoniae. This is the most commonly implicated bacteria in respiratory infections, responsible for 45 percent of the cases of community acquired pneumonia (CAP) and 34 percent of acute sinusitis. Nearly one-third of S. pneumoniae infections in the United States are resistant to penicillin and 31 percent are resistant to the macrolide antibiotic erythromycin. S. pneumoniae resistance is more common in Asia, where 53 percent of S. pneumoniae infections are penicillin resistant and 80 percent are erythromycin resistant.

The global respiratory antibiotic market was approximately $12 billion in 2002. Three major antibiotic classes dominate the respiratory antibiotic market: macrolides, beta-lactams, and quinolones. Of these classes, several respiratory antibiotics generate annual sales well in excess of $1 billion. Worldwide sales of macrolide drugs amounted to approximately $5.64 billion in 2003.

Source: Enanta Pharmaceuticals