Strong Ph III data for Arpida's iclaprim

Swiss drug developer Arpida presented the combined results from two pivotal Phase III clinical trials at the 48th annual Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington DC, showing that intravenous iclaprim provided high clinical cure rates which were similar to those of the comparator drug, linezolid, in the treatment of complicated skin and skin structure infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.

In addition, iclaprim was well-tolerated with a safety profile that compared favorably to linezolid. A New Drug Application for intravenous iclaprim in cSSSI will be discussed at the meeting of the US Food and Drug Administration Anti-Infective Drugs Advisory Committee on November 20, 2008.

In a combined efficacy analysis, the clinical cure rate at the test-of-cure visit was 82.2% for iclaprim versus 85.3% for linezolid in the intent-to-treat population and cure rates were 92.3% and 97.8%, respectively, in the per protocol population. 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%).