Arpida Presents Preclinical and Clinical Data on AR-709 at ICAAC
REINACH / BASEL, Switzerland, 20 September 2007. Arpida Ltd (SWX: ARPN) presented several preclinical studies and the results of the "first-in-man" studies on AR-709, a compound targeting community infections, 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.
AR-709 is a novel DHFR inhibitor with an outstanding
microbiological activity against streptococci in general and, very
importantly, against multi-drug resistant Streptococcus pneumoniae,
the most relevant pathogen in community-acquired pneumonia.
Moreover, the compound has been shown to be highly effective in
preclinical pneumonia models of infection both intravenously and by
the oral route. F1-938, F1-939: The two posters presented the
results of a microdosing study in man to assess the
pharmacokinetics and the concentrations of AR-709 in key lung
compartments in healthy male volunteers.
Data demonstrated that AR-709 exhibits a large volume of
distribution and a long half life in man. Very importantly AR-709
achieves high concentrations in bronchial mucosa (BM), epithelial
lining fluid (ELF) and alveolar macrophages (AM), the three key
compartments of the lungs where pathogens can reside and replicate.
F1-937: In a murine pneumococcal pneumonia model of infection,
AR-709 showed excellent efficacy against the three strains tested
which included a serotype 19A penicillin-resistant clinical
isolate. AR-709 exhibited bactericidal activity in vivo
irrespective of route of administration (intravenous, oral and
intranasal).
E-912: In a study performed by a leading laboratory, AR-709 was
highly active against a panel of 239 recent invasive multi
drug-resistant (MDR) pneumoccocal clinical isolates irrespective of
the pattern of drug resistance. Several of these isolates were
resistant to currently used gold standard and >85% were
resistant to trimethoprim/sulfamethoxazole. F1-936: The
Post-Antibiotic Effect (PAE) of AR-709 against pneumococci was
assessed under different experimental procedures. Data suggests
that even sub-MIC levels of AR-709 can significantly prolong PAE
against pneumococci. - ends -
Arpida contacts: Dr Khalid Islam, President and Tel: + 41 61 417
96 CEO Harry Welten, MBA, CFO and Senior Vice 60 Tel: + 41 61 417
96 President Paul Verbraeken, Head of Corporate 65 Tel: + 41 61 417
96 Communications 83 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
