Phase III programme with intravenous iclaprim in its first indication completed
Regulatory filing expected before year-end 2007
- Iclaprim achieves pre-specified primary efficacy endpoint in its second Phase III trial
- Safety profile confirmed
Reinach / Basel, Switzerland, 15 July 2007. Arpida Ltd. (SWX: ARPN) today announced results from the second pivotal Phase III trial with intravenous iclaprim in patients with complicated skin and skin structure infections (cSSSI). In this trial, called ASSIST-2 (Arpida’s Skin and Skin Structure Infection STudies), iclaprim was compared to linezolid, marketed by Pfizer as Zyvox®. The pre-specified primary efficacy endpoint of statistical non-inferiority in the clinical cure rate at the Test-Of-Cure (TOC) visit was achieved, confirming the outcome of ASSIST-1. Moreover, iclaprim’s safety profile demonstrated in ASSIST-1 was confirmed in ASSIST-2.