Arpida Presents Preclinical and Clinical Data on Iclaprim at Icaac
Arpida Presents Preclinical and Clinical Data on Iclaprim at Icaac
REINACH / BASEL, Switzerland, 19 September 2007 - Arpida Ltd (SWX: ARPN) presented a large body of preclinical and clinical data on its investigational drug iclaprim at the 47th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago. ICAAC is a major scientific conference where thousands of scientists and clinicians from all over the world gather to discuss the latest developments in the field of infectious diseases.
Iclaprim is a novel late stage investigational antibiotic which
exhibits potent activity against Gram-positive bacteria including
those resistant to current therapies, e.g., MRSA, VISA, VRSA etc.
In three separate efficacy trials, iclaprim has been compared
against either linezolid or vancomycin and has consistently shown
high clinical cure rates. Moreover, clinical experience to date
shows that iclaprim is well-tolerated in patients and
volunteers.
New data presented at ICAAC included large surveillance studies on
recent clinical isolates, quality control and CLSI parameters for
susceptibility testing, Phase I pharmacokinetic studies and results
from the first pivotal Phase III clinical trial (ASSIST-1). L-1142:
ASSIST-1 data on microbiological efficacy in complicated Skin and
Skin Structure Infections (cSSSI). Iclaprim showed high
microbiological eradication rates against major cSSSI pathogens,
comparable with linezolid (MRSA eradication rates were 84.7% vs.
85.3%, respectively). Additional clinical data on safety and
efficacy will be presented in October at the upcoming IDSA meeting
in San Diego. E-902, E-904, E-910, E-911: Four posters presented
data on large susceptibility studies against recent clinical
isolates: iclaprim was the most active compound tested in a study
against community-acquired and nosocomial Staphylococcus aureus
(poster E-904) and it showed good activity against streptococci and
enterococci. E-906: Iclaprim exhibited rapid bactericidal activity
against several clones of MRSA (E-MRSA, VISA, VRSA) predominant in
community and hospital infections.
Iclaprim's Post Antibiotic Effect (PAE) was comparable to other
agents in this study. B-817: A novel staphylococcal murine
preclinical model of infection was established for
diaminopyrimidines. The efficacy of iclaprim was shown to be equal
or better than that of vancomycin. E-903, E-907, E-908, E-909:
Iclaprim shows good activity against important pathogens such as
Chlamydia trachomatis, Legionella pneumophila, Neisseria
gonorrhoeae and Enterobacteriaceae.
These are involved in various clinical indications. A-804, A-805,
A-806: Important Phase I data on intravenous and oral iclaprim.
Iclaprim exhibited extensive tissue distribution, showed good oral
bioavailability and was well-tolerated in volunteers. A-803, A-807:
these posters described important data on pharmacokinetics in the
marmoset and in vitro interaction studies with CYP450 enzymes.
D-243, D-244, D-245: These posters describe the reliability of
results when testing susceptibility for iclaprim using various
methods and under different circumstances. The studies show a
narrow range of test results and a good correlation between Minimum
Inhibitory Concentrations (MICs) under different methods - ends
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Arpida contacts: Dr Khalid Islam, Tel: + 41 61 417 96 60 President and CEO Harry Welten, MBA, Tel: + 41 61 417 96 65 CFO and Senior Vice President Paul Verbraeken, Tel: + 41 61 417 96 83 Head of Corporate Communications
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.
Posted: September 2007
