September 25, 2008
Arpida Completes Enrollment in Phase II cSSSI Trial
Arpida, a biopharmaceutical company, has completed enrollment in the Phase II 'intravenous-to-oral' switch trial with oral iclaprim in patients with complicated skin and skin structure infections.
The trial was designed as a multi-centre, double-blind comparative study. Patients suffering from complicated skin and skin structure infections (cSSSI) received intravenous (IV) vancomycin for the first two days of treatment and were then randomized to either continue to receive IV vancomycin or to be switched to oral iclaprim for eight additional days. A total of 60 patients have been randomized for this study.
The key objective of the study is to assess the clinical efficacy of an oral capsule formulation of iclaprim as step-down therapy in comparison with IV vancomycin in the treatment of cSSSI. The primary endpoint is the clinical cure rate at the test-of-cure visit. Secondary objectives include bacteriological outcome as well as safety and tolerability.
Paul Hadvary, head of development at Arpida, said: "The speed of enrollment in this Phase II trial surpassed our expectations. It again shows that an 'intravenous-to-oral' step-down therapy serves a medical need and could add significant value to intravenous iclaprim. We will release the top-line data of this Phase II switch study in the coming months and subsequently determine the path ahead."