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Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia,Clinical Trial

per protocol clinical cure rate compared to Biaxin(R) in CAP (cethromycin 91.5% (205/224) compared to Biaxin(R) 95.9% (212/221) [-9.1, +0.3], p=0.0775). Cethromycin's achievement of a 91.5% clinical cure rate is consistent with its Phase 2 clinical trial results at the same 300 mg once-daily dose for CAP. The comparator drug, Biaxin(R), achieved a cure rate higher than the historical rate observed in any reported Biaxin(R) CAP clinical trials to date.

Cethromycin also achieved positive safety results in the study. Cethromycin demonstrated an improved safety profile when compared with the results seen in its previous clinical trials. Additionally, the incidence of adverse events was not statistically different between cethromycin and Biaxin(R). The most common adverse events reported in patients receiving cethromycin were mild-to-moderate diarrhea (cethromycin 5.0%, Biaxin(R) 4.6%), headache (cethromycin 3.1%, Biaxin(R) 6.5%), nausea (cethromycin 2.7%, Biaxin(R) 3.8%), vomiting (cethromycin 2.7%, Biaxin(R) 1.5%), abdominal pain (cethromycin 1.5%, Biaxin(R) 3.1%) and taste disturbance (cethromycin 11.1%, Biaxin(R) 6.2%). No drug-related serious adverse events were observed in any study subject. Liver function tests and electrocardiogram monitoring demonstrated no significant differences between subjects receiving cethromycin and subjects receiving Biaxin(R), consistent with the hepatic and cardiac side effect profile reported in cethromycin's previous clinical trials.

Cethromycin is not approved as a treatment for CAP, and data from this analysis have not been reviewed by the FDA. No further details of the clinical study will be available until all data analyses are complete and results are presented in a public, scientific forum.

Program Design

The Phase 3 CAP clinical trial program is comprised of two randomized, well controlled, double-blind, multi-center, multi-national, comparator trials designed to assess the safety and effectiveness
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