Patient recruitment has started and several additional clinical centers are expected to start recruiting within the next few weeks. The trial remains on track for completion in 2008.
The Phase II trial is designed as a multi-centre, randomized, double-blind, comparative study. The efficacy and safety of two different dosing regimens of iclaprim will be compared to the current standard of care vancomycin. More than 130 patients will be enrolled. Patients will be treated for seven-14 days and a Test-of-Cure (TOC) visit will be performed seven-14 days after the end of therapy. The primary endpoint will be the clinical cure rate at the TOC visit.
In addition, Arpida announced results of a Phase I study with oral iclaprim. The primary aim of the study was to assess the safety and tolerability of single ascending doses of an oral capsule formulation of iclaprim in healthy volunteers.
The completed Phase I study was designed as a double-blind, placebo-controlled, dose escalation trial. A total of 32 subjects participated in the study (16 males and 16 females). Safety and tolerability were evaluated after administration of supra-therapeutic doses aimed at determining the maximal tolerated dose.
No serious adverse events were reported. Only after administering five-fold the targeted therapeutic dose, the number of adverse events showed a significant increase relative to placebo and this dose was then defined as the maximal tolerated dose in humans.
Khalid Islam, president and CEO of Arpida, said: “We are now working to complete the Phase I programme while at the same time discussing with the regulatory authorities regarding the potential next steps in the development path of oral iclaprim.”