Advanced Life Sciences Announces Successful Thorough QT Study of Cethromycin
Study Results Show Cethromycin Not Associated with QT Prolongation
Advanced Life Sciences Holdings, Inc. announced positive results from Trial CL07-001, a thorough QT study of the Company's novel once-a-day oral antibiotic, cethromycin. This study was conducted to evaluate the cardiac safety of cethromycin and to enhance the safety database for the Company's upcoming New Drug Application (NDA) submission for cethromycin to treat community acquired pneumonia (CAP). The U.S. food and Drug Administration (FDA) requires thorough QT studies for all new chemical entities because prolongation in QT interval (corrected for changes in heart rate, or QTc) may signify an increased risk of developing cardiac arrhythmias.
Trial CL07-001 evaluated the potential of cethromycin to cause a prolongation in electrocardiographic QT interval in accordance with FDA and ICH E14 guidance. At the therapeutic and supratherapeutic doses, cethromycin showed no signal of any electrocardiographic effects and, hence, the study supported its favorable cardiac safety profile.
Trial CL07-001 was a double-blind, randomized, parallel study in which cethromycin, given at a therapeutic dose (300 mg once-daily for 5 days) and supratherapeutic dose (900 mg once daily for 5 days) was compared to placebo and moxifloxacin in 238 healthy adult volunteers. Moxifloxacin is an FDA approved anti-infective therapy that was used as a positive control in this study because it has been previously established to cause an increase in the QT interval.
The placebo-corrected QTc mean change from baseline (using the individual correction method for heart rate, or QTcI) for the therapeutic and supratherapeutic doses of cethromycin were -0.4 and 0.9 milliseconds, respectively. Moxifloxacin demonstrated QT prolongation of 4.9 milliseconds, which is consistent with previous clinical experience and thus validated the outcome of the study. In addition to the values for the mean QTcI interval, none of the subjects in the cethromycin cohorts showed increases in the QTcI of greater than 60 milliseconds, nor did any of the cethromycin subjects display a QTcI that exceeded 480 milliseconds at any time.
There were no deaths or serious adverse events reported in the trial in either of the cethromycin cohorts. No hepatic-related adverse events were reported for cethromycin subjects and liver function tests at the therapeutic and supratherapeutic doses were consistent with those observed in prior clinical trials with cethromycin. The most common adverse events reported among cethromycin subjects were gastrointestinal and mild-to-moderate in nature and were consistent with rates reported in prior cethromycin clinical studies at the 300 mg dose level.
Cethromycin is not approved as a treatment for CAP, and data from this analysis have not been reviewed by the FDA.
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