Advanced Life Sciences’ Pneumonia Drug Meets Trial End Point

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.

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.