Arpida Receives Green Light From FDA For Efficacy Trial With Oral Iclaprim
Arpida has received authorisation from FDA to conduct a Phase II 'intravenous-to-oral' switch trial with iclaprim in patients with complicated Skin and Skin Structure Infections (cSSSI).
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 intravenous (IV) vancomycin in the treatment of cSSSI. The primary endpoint will be the clinical cure rate at the Test-of-Cure (TOC) visit. Secondary objectives include bacteriological outcomes as well as safety and tolerability.
This Phase II trial is designed as a multi-centre, double-blind comparative study. Patients suffering from cSSSI will receive IV vancomycin for the first two days of treatment and will then be randomised to either continue to receive IV vancomycin or be switched to oral iclaprim for eight additional days. A total of 60 patients will be randomised for this study.
Iclaprim is also being developed as an intravenous formulation for two indications: cSSSI and nosocomial pneumonia. In the cSSSI indication the drug candidate has completed its pivotal Phase III trial programme and is currently in an NDA-filing process. In the nosocomial pneumonia indication, the drug candidate is currently in Phase II.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "Among the hospital anti-MRSA drugs that are currently in filing or late-stage development, only iclaprim shows good oral bioavailability and consequently offers the potential for intravenous-to- oral switch therapy. We believe that intravenous-to-oral switch therapy is important as it could provide a means to enhance patient comfort, reduce risk of spread of infection and reduce hospital-associated healthcare costs. In parallel with this Phase II trial, we are continuing our work on the Phase I programme with oral iclaprim."