By COLLEEN CREAMER
For VerusMed
Novexel’s investigational oral antibiotic, NXL103, appears to be as effective as amoxicillin in the treatment of community-acquired pneumonia (CAP), results of a new study indicate.
In the double-blind Phase II study, 300 patients with mild to moderate CAP were randomized to three treatment arms: 500 mg of NXL103 twice daily, 600 mg of NXL103 twice daily or 1,000 mg of amoxicillin three times daily for seven days.
The primary endpoints of the study were the clinical outcome in the clinically evaluable population at a follow-up visit (seven to 14 days after therapy was stopped) and safety.
Both doses of NXL103 were effective, according to Novexel, with clinical response rates similar to those observed with amoxicillin.
In the primary efficacy analysis, the response rates were 91.4 percent in the 500 mg group, 94.7 percent in the 600 mg group and 88.5 percent in the amoxicillin group.
NXL103 was generally well-tolerated, the company said, and no serious drug-related adverse events were reported during the study.
According to Novexel, NXL103 is a streptogramin antibiotic that has demonstrated potent in vitro activity against certain gram-positive bacteria, including methicillin-resistant Staphylococcus aureus, as well as respiratory pathogens, including penicillin-, macrolide- and quinolone-resistant strains.
The company said complete results from the trial would be published during the first half of 2009.
Novexel noted that Sanofi-Aventis Group elected earlier this year not to exercise its option to develop and commercialize NXL103; as a result, Novexel retained the worldwide rights to NXL103.
