Arpida Ltd has announced the completion of enrolment of its phase II “intravenous-to-oral” switch trial with oral iclaprim.
The trial – which has been developed to help treat patients with complicated skin and skin structure infections (cSSSI) – was designed as a multicentre, double-blind comparative study.
A total of 60 patients have participated in this study. In the first two days, patients suffering from cSSSI received intravenous vancomycin. From here, they were then randomly selected to either continue with the treatment with vancomycin or they were switched to oral iclaprim for a further eight days.
Dr Paul Hadvary – head of development of Arpida Ltd – commented on the trial: “The speed of enrolment 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. Marketing applications for intravenous iclaprim have been filed in the USA, the European Union and Canada. We will release the top-line data of this phase II switch study in the coming months and subsequently determine the path ahead.”
The study’s key objective 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 trial also sets out to identify the bacterialogical outcome of the drug as well as its safety and tolerability.