Arpida Ltd (SWX: ARPN) today announced the enrolment of the first patients into the Phase II "intravenous-to-oral" switch trial with oral iclaprim in complicated Skin and Skin Structure Infections (cSSSI). Enrolment remains on track for completion in 2008.
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 a full course of intravenous (i.v.) treatment with 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, double-dummy comparative study. Patients suffering from cSSSI receive i.v. vancomycin for the first two days of treatment and are then randomised to either continue to receive i.v. vancomycin or to be switched to oral iclaprim for eight additional days. A total of 60 patients will be randomised for this study.
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 oral bioavailability allowing clinical development and consequently offers the potential for intravenous-to-oral switch therapy. We consider the oral switch therapy to be an important option addressing an increasing therapeutic need. It allows patients to be sent home earlier, thereby increasing patient comfort, reducing the risk of contracting additional infections and lowering costs for the healthcare system. We feel the oral switch therapy could add significant potential to the intravenous formulation."
This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
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 a full course of intravenous (i.v.) treatment with 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, double-dummy comparative study. Patients suffering from cSSSI receive i.v. vancomycin for the first two days of treatment and are then randomised to either continue to receive i.v. vancomycin or to be switched to oral iclaprim for eight additional days. A total of 60 patients will be randomised for this study.
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 oral bioavailability allowing clinical development and consequently offers the potential for intravenous-to-oral switch therapy. We consider the oral switch therapy to be an important option addressing an increasing therapeutic need. It allows patients to be sent home earlier, thereby increasing patient comfort, reducing the risk of contracting additional infections and lowering costs for the healthcare system. We feel the oral switch therapy could add significant potential to the intravenous formulation."
This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
