Overall, iclaprim was found to be safe and well-tolerated at a dose of 0.8 mg/kg in the Phase III ASSIST trials. Adverse events were found to be less frequent among patients treated with iclaprim as compared to linezolid. In earlier Phase I trials, iclaprim was shown to have a low propensity for interactions with other drugs.
"These data further support the safety and efficacy of iclaprim as a potential treatment against complicated skin and skin structure infections," said Jrgen Raths MD, President and CEO of Arpida. "Arpida remains encouraged and optimistic about the potential of iclaprim for the treatment of MRSA and related infections, and looks forward to bringing iclaprim to market, providing a new treatment option for physicians."
The ASSIST Trials
The ASSIST trials were randomized, multi-center, double-blind, Phase III studies designed to establish the efficacy and safety of iclaprim in the treatment of patients with cSSSI known or suspected to be caused by Gram-positive pathogens. The trials were of essentially identical design, making a combined analysis of iclaprim possible in a larger population. A 95 percent confidence interval was used to determine statistical significance of study data and the pre-specified non-inferiority margin (-12.5 percent) was met in all populations in both trials.
A total of 991 patients, 18 years old and over with cSSSIs were enrolled in the trials. Patients were treated for 10 to 14 days with either 0.8 mg/kg iclaprim or 600 mg linezol
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