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news.Advanced Life Sciences has announced positive results from the second of two pivotal Phase III clinical trials designed to assess the safety and effectiveness of cethromycin, a novel once-a-day oral antibiotic for the treatment of mild-to-moderate community acquired pneumonia.
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The primary efficacy endpoint of statistical non-inferiority in the clinical cure rate at the test of cure visit was achieved. The study results showed that cethromycin cured 94% of patients with community acquired pneumonia (CAP), compared to Biaxin (clarithromycin), a current standard of care treatment for CAP, which cured 93.8% of studied patients in the per protocol population.
In the modified intent to treat population, cethromycin cured 83.1% of patients and Biaxin cured 81.1%. Cethromycin also demonstrated favorable safety results, with reported side effects similar to or less than those seen with Biaxin.
The trial was a double-blind, randomized, multi-center, multi-national, comparator Phase III clinical study in which cethromycin was compared to Biaxin, an approved antibiotic, in treating mild-to-moderate CAP. The trial design called for a seven-day course of therapy in which cethromycin was evaluated using a 300mg once-daily dosing regimen compared to a 250mg twice-daily dosing regimen of Biaxin. In the study, 584 adult patients were enrolled from clinics in the US, Canada and South Africa.