A new antibiotic that shows promise in treating the superbug MRSA and related infections is poised to enter the market after phase III ASSIST trials in the US.
Intravenous iclaprim, a novel antibiotic, is reported by manufacturer Arpida to show high clinical cure rates similar to those of the comparator drug, linezolid.
The test results were gathered from the ASSIST-1 and ASSIST-2, (Arpida’s skin and skin structure infection study) pivotal Phase III studies involving a total of 991 patients.
Data from the studies also show that iclaprim exhibited a high eradication rate for MRSA (76.4%), which was comparable to that of linezolid (78.7%).
Arpida president and CEO Jürgen Raths said: “These data further support the safety and efficacy of iclaprim as a potential treatment against complicated skin and skin-structure infections.
“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.”
A new drug application will now be discussed at the meeting of the US Food and Drug Administration anti-infective drugs advisory committee on 20 November 2008.
Copyright PA Business 2008