Arpida Completes Enrolment in Phase II "Intravenous-to-Oral" Switch ..

Tag : switch
REINACH, Switzerland, September 24 /PRNewswire-FirstCall/ -- ArpidaLtd. (SWX: ARPN) today announced the completion of enrolment in thePhase II 'intravenous-to-oral' switch trial with oral iclaprim inpatients with complicated Skin and Skin Structure Infections(cSSSI).

The trial was designed as a multi-centre, double-blind comparativestudy. Patients suffering from cSSSI received intravenous (IV)vancomycin for the first two days of treatment and were thenrandomised to either continue to receive IV vancomycin or to beswitched to oral iclaprim for eight additional days. A total of 60patients have been randomised for this study.

The key objective of the study is to assess the clinical efficacyof an oral capsule formulation of iclaprim as step-down therapy incomparison with IV vancomycin in the treatment of cSSSI. Theprimary endpoint is the clinical cure rate at the Test-of-Cure(TOC) visit. Secondary objectives include bacteriological outcomeas well as safety and tolerability.

Dr Paul Hadvary, Head of Development of Arpida Ltd., commented:"The speed of enrolment in this Phase II trial surpassed ourexpectations. It again shows that an 'intravenous-to-oral'step-down therapy serves a medical need and could add significantvalue to intravenous iclaprim. Marketing applications forintravenous iclaprim have been filed in the U.S.A., the EuropeanUnion and Canada. We will release the top-line data of this PhaseII switch study in the coming months and subsequently determine thepath ahead."

About Arpida Ltd.

Arpida (SWX: ARPN) is a biopharmaceutical company headquartered inReinach, Switzerland with operations in Switzerland and the USA. Itfocuses on the discovery, development and commercialisation ofnovel drugs that seek to overcome the growing problem of microbialresistance. The most advanced compounds include an antibacterialunder regulatory review and an antifungal in Phase III.

Arpida's leading product candidate is intravenous iclaprim, apotent antibacterial that targets severe infections requiringhospital treatment, including those caused by methicillin-resistantStaphylococcus aureus (MRSA). The clinical programme for the firstindication, complicated skin and skin structure infections (cSSSI),has been completed. The submission of the NDA to the US FDA wascompleted in March 2008. The FDA has defined that the PrescriptionDrug User Fee Act (PDUFA) goal date will be 16 January 2009. Arpidasubmitted a Marketing Authorisation Application for intravenousiclaprim with EMEA in July 2008. EMEA notified that it had acceptedthe MAA for review in August 2008.

In December 2007, Arpida announced the enrolment of the firstpatients in a Phase II clinical study with intravenous iclaprim inthe treatment of patients with hospital-acquired pneumonia (HAP),ventilator-associated pneumonia (VAP) or healthcare associatedpneumonia (HCAP).

In May 2008, Arpida announced the enrolment of the first patientsin a Phase II 'intravenous-to-oral' switch trial. Iclaprim could beoffered not only as an intravenous therapy for hospital use inacute situations, but also as an oral formulation, allowing earlypatient discharge followed by outpatient treatment. This switchcould be a valuable instrument in reducing healthcare costs andenhancing patient comfort.

Arpida's fourth most advanced antibiotic programme, AR-709, targetsupper and lower respiratory tract infections acquired in thecommunity setting. AR-709 exhibited potent activity against a largepanel of pneumococcal clinical isolates including those resistantto 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 ofconcept. AR-2474 has been shown to be effective in eradicatingpathogens in preclinical models of skin infection and nasalcarriage.

Apart from the antibiotic programmes, Arpida has an innovativeantifungal therapy (TLT) which is in Phase III clinical trials inEurope, targeting onychomycosis.

Moreover, the company has several other leads in optimisation andadditional discovery programmes derived from its own discoveryplatform at various research stages.

This press release contains specific forward-looking statements,e.g. statements including terms like believe, assume, expect orsimilar expressions. Such forward-looking statements are subject toknown and unknown risks, uncertainties and other factors which mayresult in a substantial divergence between the actual results,financial situation, development or performance of the company andthose explicitly or implicitly presumed in these statements.Against the background of these uncertainties readers should notplace undue reliance on forward-looking statements. The companyassumes no responsibility to update forward-looking statements orto adapt them to future events or developments.

Contacts: Dr Jurgen Raths, President and 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 CorporateCommunications, Tel.: +41-61-417-96-83 SOURCE Arpida Ltd.




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