REINACH and BASEL, Switzerland, November 2 /PRNewswire-FirstCall/ -- Arpida Ltd presents two clinical posters on its late-stage investigational antibiotic iclaprim at the 9th annual congress for Clinical Pharmacology (Verbund Klinische Pharmakologie - VKliPha) which takes place 1-3 November in Kiel, Germany. The posters presented at the conference further expand the substantial volume of data on iclaprim that is already available. At two recent conferences in the United States, Arpida has presented a total of 24 posters on iclaprim.
Poster F-1 discusses results of Phase I studies with intravenous iclaprim in healthy volunteers. In the studies, iclaprim showed linear, predictable and gender-independent pharmacokinetic characteristics in a clinically relevant dose range. Moreover, results showed iclaprim to be safe and well-tolerated in the studies.
Poster F-25 examines the influence of ketoconazole on the pharmacokinetics and safety of intravenous iclaprim. Ketoconazole did not affect the pharmacokinetics of iclaprim. Ketoconazole is a synthetic antifungal drug used to prevent and treat skin and fungal infections, especially in immunocompromised patients. In drug-drug interaction studies, it is often used as a reference compound due to its potent inhibition of the cytochrome P450 3A4 system
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: “The data presented in Kiel highlight several aspects of iclaprim’s attractive profile. In these Phase I studies iclaprim’s pharmacokinetics were shown to be predictable and unaffected by ketaconazole. Moreover, the good safety profile was confirmed. As at the previous ICAAC and IDSA conferences, we’ve encountered a lively interest in iclaprim among the congress attendees in Kiel. This again reinforces the view that there is an urgent need for new pathogen-focused antibiotics to address some of the most threatening multi-drug resistant bacteria, including MRSA. We feel iclaprim could in the future play an important role in combating life-threatening infections caused by ‘the superbug’.”
The Phase I data presented in Kiel will be part of the NDA package that is expected to be submitted to the US Food and Drug Administration in the course of this year. Overall, the clinical programmes with iclaprim and the path towards the NDA filing for intravenous iclaprim in its first indication are on track. Patient enrolment into the Phase II studies with intravenous iclaprim in its second indication (HAP/VAP/HCAP) as well as into the Phase III trial with the TLT therapy in onychomycosis is expected to get underway shortly.
Arpida has a comfortable cash position, with cash and financial investments of CHF 95 million at the end of June 2007.
Arpida plans to give further updates on the progress of intravenous and oral iclaprim as well as TLT in the course of this year.
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. The most advanced compounds include an antibacterial close to NDA-filing and an antifungal in Phase III.
Arpida’s leading product candidate is intravenous iclaprim, a potent, pathogen-focused, late-stage 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 March 2007, Arpida completed patient enrolment in the second pivotal Phase III trial in complicated skin and skin structure infections. The top-line data of the second trial were reported in July 2007. 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 antibiotic 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.
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
