Arpida Presents Additional Data on Iclaprim at IDSA
REINACH / BASEL, Switzerland, Oct. 9, 2007- Arpida Ltd (SWX: ARPN) presented several posters containing clinical data on its late-stage investigational antibiotic iclaprim at the 45th Annual Meeting of the Infectious Diseases Society of America (IDSA). IDSA is a major conference where infectious disease specialists and clinical researchers gather to discuss the latest developments in the field of infectious diseases.
Arpida supported a symposium entitled: "Emerging Treatments for
Resistant Bacterial Infections - The Concept of Pathogen-focused
Therapy". The faculty consisted of key opinion leaders such as
Louis Rice, John Bartlett, Donald Craven, Robert Moellering, Dennis
Stevens and George Eliopoulos. Arpida also had a booth at the IDSA
meeting which was very well visited and Arpida's compound met with
lively interest from the conference attendees. Arpida presented
five posters on clinical aspects of iclaprim, following on the
heels of the 19 presentations at ICAAC in late September
2007.
Poster 1079 described iclaprim's efficacy in the first of two
pivotal Phase III trials in complicated skin and skin structure
infections (ASSIST-1). The results showed that iclaprim exhibited
high clinical cure rates and achieved its pre-specified primary
endpoint of non-inferiority to linezolid in this study.
Posters 432 and 1083 discussed the effect of iclaprim on the QT
interval in healthy volunteers (Phase I) and in patients (Phase
III; ASSIST-1), respectively. Both studies concluded that the QT
prolongation is transient and rapidly reversible. In patients the
QT changes observed after one day and four days of dosing with
iclaprim were 6.3 ms and 3.8 ms, respectively. After correcting for
comparator control a 4-5 ms QT change from pre-treatment values was
observed in ASSIST-1.
Poster 1104 gave an overview of iclaprim's safety profile in the
ASSIST-1 trial. There were no treatment-related serious adverse
events in this study. None of the mild-to-moderate adverse events
that were possibly/probably related to treatment occurred in more
than 3% of the iclaprim group.
Poster 448 summarised the results of a Phase I study investigating
the pharmacokinetics of iclaprim in special populations with
varying degrees of renal and hepatic impairment and obesity. The
results of the study showed that iclaprim was safe and
well-tolerated in all these special populations. Furthermore, the
predictable pharmacokinetics observed in these populations would
suggest that monitoring may not be required.
Dr Khalid Islam, President and CEO of Arpida Ltd commented: "The
high level of interest at the IDSA meeting further confirms the
positive reception we've seen at ICAAC. The clinical data that we
presented at this conference shed additional light on both efficacy
and safety of iclaprim. Overall, these data and their reception at
the two recent conferences highlight iclaprim's potential to become
a potent novel drug with promising pathogen-focused efficacy
against some of the most threatening multi-drug resistant
bacteria."
About Arpida Ltd.
Arpida (SWX: ARPN) is a biopharmaceutical company with research
facilities near Basel, 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.
Arpida's leading product candidate is intravenous iclaprim, a
broad-spectrum 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 July
2007, Arpida reported the completion of the Phase III programme in
complicated skin and skin structure infections. An NDA filing is
expected to take place in the second half of 2007.
In June 2007, Arpida announced that it has received approval from
the US FDA to initiate Phase II trials with intravenous iclaprim in
the treatment of patients with hospital-acquired pneumonia (HAP),
ventilator-associated pneumonia (VAP) or healthcare associated
pneumonia (HCAP).
An oral formulation of iclaprim has successfully completed three
Phase I trials: an ADME study (absorption, distribution, metabolism
and excretion) with radiolabelled compound, a Phase I
bioavailability trial with a solution and one with a capsule
formulation. 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 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 is about to enter 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 Tel: + 41 61 417
96 65 President Paul Verbraeken, Head of Corporate Tel: + 41 61 417
96 83 Communications
Posted: October 2007
