Arpida clarifies Ph III iclaprim trial data

Arpida has reiterated its confidence in its lead drug candidate, intravenous iclaprim, in complicated skin and skin structure infections (cSSSI). The Swiss drugmaker noted that it met its pre-specified primary endpoint in both pivotal Phase III trials: ASSIST-1 and ASSIST-2.

According to the firm, the aim of these trials is to provide an unbiased assessment of treatment and takes into account all populations, adding that the intent-to-treat and per protocol population are particularly relevant. As reported in July 2007, imbalances were noted in the ASSIST-2 trial - in particular due to the use of prohibited antibiotics, Arpida noted, adding that the correction for this imbalance in the PP population results in the modified-clinically-evaluable dataset and shows that it is in close agreement with the ITT population. The pre-specified primary endpoint for both trials required that the lower bound of the confidence interval for treatment difference remain within minus 12.5%, which was met in all relevant populations.