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Arpida receives green light from US FDA for Phase II efficacy trial with oral iclaprim

(PresseBox) (Reinach, ) Arpida Ltd. (SWX: ARPN) today announced that it has received authorisation from the U.S. Food and Drug Administration (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."

Evolva Holding SA

Arpida (SWX: ARPN) 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 in an NDA-filing process and an antifungal in Phase III.

Arpida’s leading product candidate is intravenous iclaprim, a potent late-stage antibiotic that targets severe infections requiring hospital treatment, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The US Food and Drug Administration has granted fast track status to intravenous iclaprim. In March 2007, Arpida completed patient enrolment in the second pivotal Phase III trial in complicated skin and skin structure infections. The top-line data of the second trial were reported in July 2007. The NDA-filing process is ongoing and expected to be completed by the end of February 2008.

In December 2007, Arpida announced the enrolment and dosing 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 should 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 highly 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 has authorisation to commence 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.