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The trial was designed as a multi-centre, double-blind comparative study.Patients suffering from cSSSI received intravenous (IV) vancomycin for thefirst two days of treatment and were then randomised to either continue toreceive IV vancomycin or to be switched to oral iclaprim for eight additionaldays. A total of 60 patients have been randomised for this study.
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The key objective of the study is to assess the clinical efficacy of anoral capsule formulation of iclaprim as step-down therapy in comparison withIV vancomycin in the treatment of cSSSI. The primary endpoint is the clinicalcure rate at the Test-of-Cure (TOC) visit. Secondary objectives includebacteriological outcome as well as safety and tolerability.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "Thespeed of enrolment in this Phase II trial surpassed our expectations. Itagain shows that an 'intravenous-to-oral' step-down therapy serves a medicalneed and could add significant value to intravenous iclaprim. Marketingapplications for intravenous iclaprim have been filed in the U.S.A., theEuropean Union and Canada. We will release the top-line data of this Phase IIswitch study in the coming months and subsequently determine the path ahead."
About Arpida Ltd.
Arpida (SWX: ARPN) is a biopharmaceutical company headquartered inReinach, Switzerland with operations in Switzerland and the USA. It focuseson the discovery, development and commercialisation of novel drugs that seekto overcome the growing problem of microbial resistance. The most advancedcompounds include an antibacterial under regulatory review and an antifungalin Phase III.
Arpida's leading product candidate is intravenous iclaprim, a potentantibacterial that targets severe infections requiring hospital treatment,including those caused by methicillin-resistant Staphylococcus aureus (MRSA).The clinical programme for the first indication, complicated skin and skinstructure infections (cSSSI), has been completed. The submission of the NDAto the US FDA was completed in March 2008. The FDA has defined that thePrescription Drug User Fee Act (PDUFA) goal date will be 16 January 2009.Arpida submitted a Marketing Authorisation Application for intravenousiclaprim with EMEA in July 2008. EMEA notified that it had accepted the MAAfor review in August 2008.
In December 2007, Arpida announced the enrolment of the first patients ina Phase II clinical study with intravenous iclaprim in the treatment ofpatients with hospital-acquired pneumonia (HAP), ventilator-associatedpneumonia (VAP) or healthcare associated pneumonia (HCAP).
In May 2008, Arpida announced the enrolment of the first patients in aPhase II 'intravenous-to-oral' switch trial. Iclaprim could be offered notonly as an intravenous therapy for hospital use in acute situations, but alsoas an oral formulation, allowing early patient discharge followed byoutpatient treatment. This switch could be a valuable instrument in reducinghealthcare costs and enhancing patient comfort.
Arpida's fourth most advanced antibiotic programme, AR-709, targets upperand lower respiratory tract infections acquired in the community setting.AR-709 exhibited potent activity against a large panel of pneumococcalclinical isolates including those resistant to currently used drugs.Promising results of "first-in-man" studies with AR-709 were published inMarch 2007.
An additional compound, AR-2474, has achieved in vivo proof of concept.AR-2474 has been shown to be effective in eradicating pathogens inpreclinical models of skin infection and nasal carriage.
Apart from the antibiotic programme
