Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of...(earwill form the core of our New Drug Ap...),Health

Trial CL-05 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 300 mg once-daily dosing regimen compared to a 250 mg twice-daily dosing regimen of Biaxin. In the study, 584 adult patients were enrolled from clinics in the United States, Canada and South Africa.

"The need for new drugs to address CAP is imperative, as bacterial resistance rates and adverse effects continue to increase with currently approved antibiotics," said Dr. John Bartlett, Professor of Medicine in the Division of Infectious Diseases at The Johns Hopkins University School of Medicine and past President of the Infectious Diseases Society of America (IDSA). "Cethromycin's unique mechanism of action allows it to overcome resistance and minimize adverse effects such as Clostridium difficile associated disease (CDAD) and other serious side effects. With these advantages, cethromycin may offer physicians a better treatment option for CAP. The high clinical cure rates and favorable safety profile demonstrated in the cethromycin clinical development program is evidence of the potential value of this drug to CAP patients."

Approximately 5.6 million cases of CAP are diagnosed each year in the United States, resulting in an estimated total annual expenditure of $2 billion dollars for prescribed antibiotics to treat CAP. CAP is potentially fatal if not treated properly, and the bacteria that cause CAP are developing resistance to current standard of care treatments.

"Antimicrobial resistance in important respiratory pathogens, such as the pne
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