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news.Advanced Life Sciences has released supplemental data from a pivotal phase III trial comparing its once-daily antibiotic cethromycin to Abbott's Biaxin in the treatment of community-acquired pneumonia.
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The company said that the modified intent-to-treat clinical cure rate for cethromycin was 82.9%, compared to 88.5% for Biaxin. Under this analysis, the study met the endpoint of non-inferiority.
Advanced Life Sciences said that cethromycin also met the endpoint of per protocol radiographic success rate and a modified intent-to-treat radiographic success rate.
Cethromycin was evaluated using a 300mg once-daily dosing regimen compared to 250mg twice-daily dosing for Biaxin, both over a seven-day course of therapy. The clinical cure rates in the modified intent to treat population and the per protocol population observed in this trial with cethromycin were in line with cethromycin phase II results and with clinical cure rates observed with currently marketed antibiotics.
Michael Flavin, CEO of Advanced Life Sciences, said: “This successful trial will be a key part of our NDA submission.”