Arpida Receives Green Light From US FDA for Phase II Efficacy Trial With Oral Iclaprim

Arpida Receives Green Light From US FDA for Phase II Efficacy Trial With Oral
Iclaprim

REINACH, Switzerland, January 15 /PRNewswire-FirstCall/ -- 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."
About Arpida Ltd.
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.
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.
Arpida contacts:

Dr Khalid Islam, 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 Corporate Communications
Tel: + 41-61-417-96-83

SOURCE Arpida Ltd.

Arpida contacts: Dr Khalid Islam, 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 Corporate Communications, Tel: + 41-61-417-96-83