REINACH, Switzerland, May 26 /PRNewswire-FirstCall/ -- Arpida Ltd 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.”
About Arpida Ltd.
Arpida is a biopharmaceutical company with research facilities in Reinach, Switzerland and in the USA. It focuses on the discovery and development of novel drugs that seek to overcome the growing problem of microbial resistance. The most advanced compounds include an antibacterial under regulatory review and an antifungal in Phase III.
Arpida’s leading product candidate is intravenous iclaprim, a potent antibacterial 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 skin structure infections (cSSSI), has been completed. The submission of the NDA to the US FDA was completed in March 2008. The FDA has defined that the Prescription Drug User Fee Act (PDUFA) goal date will be 16 January 2009.
In December 2007, Arpida announced the enrolment of the first patients in a Phase II clinical study with intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP).
In January 2008, the US FDA granted authorisation to progress oral iclaprim into a Phase II ‘intravenous-to-oral’ switch trial. Iclaprim could be offered not only as an intravenous therapy for hospital use in acute situations, but also as an oral formulation, allowing early patient discharge followed by outpatient treatment. This switch could be a valuable instrument in reducing healthcare costs and enhancing patient comfort.
Arpida’s fourth most advanced antibiotic programme, AR-709, targets upper and lower respiratory tract infections acquired in the community setting. AR-709 exhibited potent activity against a large panel of pneumococcal clinical isolates including those resistant to currently used drugs. Promising results of “first-in-man” studies with AR-709 were published in March 2007.
An additional compound, AR-2474, has achieved in vivo proof of concept. AR-2474 has been shown to be effective in eradicating pathogens in preclinical models of skin infection and nasal carriage.
Apart from the antibiotic programmes, Arpida has an innovative antifungal therapy (TLT) which is in Phase III clinical trials in Europe, targeting onychomycosis.
Moreover, the company has several other leads in optimisation and additional discovery programmes derived from its own discovery platform at various research stages.
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.
CONTACT: Arpida: Dr Jurgen Raths, CEO, Tel: +41-61-417-96-60; Harry
Welten, MBA, CFO and Senior Vice President, Tel: +41-61-417-96-65; Paul
Verbraeken, Head of Corporate Communications, Tel: +41-61-417-96-83
