The trial will take place in the US and Canada investigating the safety, tolerability and efficacy of EDP-420, an investigational bridged bicyclic macrolide antibiotic for the treatment of community-acquired respiratory tract infections.
Community-acquired pneumonia (CAP) is the sixth most common cause of death in the US, according to Enanta. CAP and other respiratory tract infections are caused by pathogens such as S. pneumonia. CAP affects five to six million patients in the US each year, with 10 million physician visits, one million hospitalizations occurring annually and a cost of $21 billion dollars.
“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 III clinical trials,” said Dr Yat Sun Or, senior vice president of R&D at Enanta.
Dr Or said the trial marked the beginning of an expansive phase II development program for EDP-420 in the US. The company plans to evaluate the use of EDP-420 in a number of indications including acute bacterial exacerbation of chronic bronchitis, acute sinusitis and tonsillitis. The drug will also be studied in Japan through Enanta’s partner firm Shionogi & Co, which teamed up with Enanta in December 2005.