Enanta Pharma initiates Phase 2 macrolide study
studies investigating a first in class antibiotic candidate that
treats community-acquired respiratory tract infections, which has
become the sixth most common cause of death in the US.
EDP-420 is a first-in-class bridged bicyclic macrolide antibiotic that has shown an excellent pharmacokinetic profile, complementing an improved preclinical activity profile over currently available drugs such as macrolides and ketolides including against many strains of resistant S. pneumoniae.
This is the most commonly implicated bacterium in respiratory infections, responsible for 45 per cent of the cases of community-acquired pneumonia (CAP) and 34 per cent of acute sinusitis.
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.
"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," said Yat Sun Or, senior vice president of research and development at Enanta.
"EDP-420 will be evaluated in multiple indications including community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, acute sinusitis, tonsillitis/pharyngitis, and otitis media," he added,
Community-acquired pneumonia (CAP) and other respiratory tract infections are caused by pathogens such as S. pneumonia and affects 5-6 million patients in the United States each year, with 10 million physician visits, 1 million hospitalisations occurring annually and a cost of $21 billion (€17.3 billion)
Nearly one-third of S. pneumoniae infections in the US are resistant to penicillin and 31 per cent are resistant to the macrolide antibiotic erythromycin. S. pneumoniae resistance is more common in Asia, where 53 per cent of S. pneumoniae infections are penicillin resistant and 80 per cent are erythromycin resistant.
Although antibacterial research has declined in many larger pharmaceutical companies, small companies have begun to fill in the gap. Antibacterial discovery research is currently being conducted in at least 35 small companies, of which Enanta features prominently. One successful approach taken by small pharma has been to continue clinical programmes that were abandoned by large companies.
2005 saw the launch of the first in a new class of antibiotics, the glycylcyclines from Wyeth. The product, tigecycline (Tygacil) joins the oxazolidinones, (Pfizer's linezolid) and lipopeptides (Cubist's daptomycin) in a small but growing arsenal against drug-resistant bacterial infections.
