Enanta initiates Phase 1 trial on BBK antibiotic for RTI

Designed by Enanta, the compound is designed to provide broad treatment against respiratory pathogens, including several multi-drug resistant strains for which traditional macrolides, penicillins, and fluoroquinolones are no longer effective.

Macrolides have become increasingly prone to resistance and offer weak activity against certain problem community-acquired pathogens. S. pneumoniae is one of the most commonly implicated bacteria in respiratory infections, responsible for 45 per cent of the cases of community acquired pneumonia (CAP) and 34 per cent of acute sinusitis. 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.

Jay Luly, President and CEO of Enanta Pharmaceuticals described the clinical trial as 'an important milestone'​ for the company adding its blockbuster potential would go some way in satisfying a growing unmet medical need.

"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,"​ added Robert Moellering, infectious disease specialist at Harvard Medical School.

Enanta is developing EP-013420 for the treatment of respiratory tract infections with potential indications for community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, tonsilitis/pharyngitis, and otitis media.

One other ketolide variant aiming to overcome these limitations is telithromycin. In February 2003, Aventis Pharma, Sankyo Co and Fujisawa Pharmaceutical entered into a basic agreement concerning a marketing alliance for this oral ketolide class antibiotic.

Telithromycin was first launched in Germany in October 2001 and has been approved in all EU and major Latin American markets under the brand name Ketek.

S. pneumoniae is one of the most commonly implicated bacteria in respiratory infections, responsible for 45 per cent of the cases of community acquired pneumonia (CAP) and 34 per cent of acute sinusitis. 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.

The global respiratory antibiotic market was approximately $12 billion (€9.9billion) in 2002. Three major antibiotic classes dominate the respiratory antibiotic market. These are the 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.