Arpida Presents Additional Data on iclaprim at IDSA
REINACH and BASEL, Switzerland, October 09, 2007 /PRNewswire-FirstCall/ -- Arpida Ltd 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 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 President Tel: +41-61-417-96-65 Paul Verbraeken, Head of Corporate Communications Tel: +41-61-417-96-83
CONTACT: 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
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Posted: October 2007