Novexel reports positive results from Phase II pneumonia trial

The NXL103 Phase II study was a double-blind, multinational, randomized, comparative study that evaluated this oral antibacterial as a treatment for mild to moderate community acquired pneumonia. The study recruited 300 adult patients in nine countries in both the northern and southern hemispheres.

Patients were randomized (1:1:1) to three treatment arms: 500mg of NXL103 twice a day, 600mg NXL103 twice a day or 1,000mg of amoxicillin three times a day for seven days. The key endpoints of the study were the clinical outcome in the clinically evaluable population at the early follow-up visit (seven to 14 days post-therapy) and safety. In this study, both doses of NXL103 were effective, with clinical response rates similar to those seen in the amoxicillin group.

For the primary efficacy analysis, response rates were 91.4% in the 500mg NXL103 group; 94.7% in the 600mg NXL103 group; and 88.5% in the amoxicillin group. NXL103 was generally well tolerated with the most frequent adverse events related to gastrointestinal intolerance. There were no serious drug-related adverse events reported in the study. The complete results from this Phase II trial will be published in the first half of 2009.

In the second quarter of 2008 Sanofi-Aventis elected not to exercise its option to develop and commercialize NXL103. Consequently, worldwide rights to the NXL103 program are retained by Novexel.

NXL103 is an oral streptogramin antibiotic that has potent in vitro activity against certain Gram positive bacteria including methicillin resistant Staphylococcus aureus as well as the important respiratory pathogens including penicillin, macrolide and quinolone resistant strains, said Novexel.