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
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 -
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