WATERTOWN, Mass., Jan. 19 /PRNewswire/ -- Enanta Pharmaceuticals announced today the initiation of a Phase 2 clinical trial for the treatment of community acquired pneumonia (CAP) in the United States and Canada for EDP-420, an investigational bridged bicyclic macrolide antibiotic for the treatment of community-acquired respiratory tract infections. Enanta scientists discovered EDP-420 and the Company retains development and commercialization rights to this program worldwide, excluding East Asia. In December 2005, Enanta announced that its East Asia partner, Shionogi & Co., Ltd., initiated Phase 2 studies in Japan for EDP-420.
“Our first Phase 2 study in the United States and Canada for EDP-420 will enable Enanta to evaluate the safety, tolerability, and efficacy of EDP-420 for the treatment of community acquired pneumonia,” said Yat Sun Or, Ph.D., Senior Vice President of Research and Development at Enanta. “This trial is anticipated to support the evaluation of EDP-420 as a broad-spectrum macrolide antibiotic for the treatment of community respiratory tract infections, including activity against resistant S. pneumonia, as well as enabling a decision to advance to Phase 3 clinical trials.”
Dr. Or added, “It also marks the beginning of an expansive Phase 2 clinical development program underway for EDP-420 in North America. EDP-420 will be evaluated in multiple indications moving forward, including community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, acute sinusitis, tonsillitis/pharyngitis, and otitis media.”
Community Acquired Pneumonia (CAP)
CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as S. pneumonia. CAP affects 5-6 million patients in the United States each year, with 10 million physician visits, 1 million hospitalizations occurring annually and a cost of 21 billion dollars.
About EDP-420
Enanta is developing EDP-420 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. EDP-420 is a first-in-class Bridged Bicyclic Macrolide antibiotic that is the result of Enanta’s innovative medicinal chemistry approach to creating novel and proprietary chemical structures. Preclinical and Phase 1 clinical studies have shown an excellent pharmacokinetic profile for EDP-420, complementing an improved preclinical activity profile relative to currently marketed macrolides and ketolides, including against many strains of resistant S. pneumoniae. This is the most commonly implicated bacteria in respiratory infections, responsible for 45% of the cases of community-acquired pneumonia (CAP) and 34% of acute sinusitis. Nearly one-third of S. pneumoniae infections in the US are resistant to penicillin and 31% are resistant to the macrolide antibiotic erythromycin. S. pneumoniae resistance is more common in Asia, where 53% of S. pneumoniae infections are penicillin resistant and 80% are erythromycin resistant.
About Enanta
Enanta Pharmaceuticals is a research and development company, which 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. The Company successfully integrates chemistry with biology, in order to discover and develop novel small molecules that address the following significant, unmet medical needs: a new class of macrolide and ketolide antibiotics to overcome bacterial resistance and antiviral agents targeted against the Hepatitis C virus (HCV). Enanta is a privately held company with offices in Watertown, MA. More information about the company can be found at http://www.enanta.com.
For Investor Relations, please contact: Paul Mellett Senior Vice President and Chief Financial Officer (617) 607-0761 pmellett@enanta.com For Public Relations, please contact MacDougall Biomedical Communications: Kari Watson (508) 647-0209 kwatson@macbiocom.com
Enanta Pharmaceuticals
CONTACT: Investor Relations - Paul Mellett, Senior Vice President andChief Financial Officer of Enanta Pharmaceuticals, +1-617-607-0761,pmellett@enanta.com, or Public Relations - Kari Watson of MacDougallBiomedical Communications for Enanta Pharmaceuticals, +1-508-647-0209,kwatson@macbiocom.com
Web site: http://www.enanta.com/
