Progress of Phase I Programme With Oral Iclaprim "Rolling" NDA for Intravenous Iclaprim in cSSSI; Electronic Submission of
First Modules due Before Year-end 2007
REINACH, Switzerland, December 12 /PRNewswire-FirstCall/ -- Arpida Ltd (SWX: ARPN) announced today the enrolment and dosing of the first patients in the Phase II clinical study with intravenous iclaprim in the treatment of hospital-acquired pneumonia (HAP) / ventilator-associated pneumonia (VAP) / healthcare-associated pneumonia (HCAP).
In addition, Arpida announced results of a Phase I study with oral iclaprim. The primary aim of the study was to assess the safety and tolerability of single ascending doses of an oral capsule formulation of iclaprim in healthy volunteers.
Moreover, Arpida today announced that the first modules of the New Drug Application (NDA) for intravenous iclaprim in its first indication, cSSSI, are ready and will be filed before year-end 2007. The filing of the NDA package is expected to be completed by the end of February 2008.
First patients enrolled in Phase II trial with intravenous iclaprim in HAP/VAP/HCAP
Patient recruitment has started and several additional clinical centres are expected to start recruiting within the next few weeks. The trial remains on track for completion in 2008.
HAP/VAP/HCAP as a potential second indication could substantially enhance iclaprim's prospects as a potent novel therapy against multi-drug resistant bacteria. In the area of pneumonia, the need for new drugs addressing MRSA-infections is particularly pressing.
The Phase II trial is designed as a multi-centre, randomised, double-blind, comparative study. The efficacy and safety of two different dosing regimens of iclaprim will be compared to the current standard of care vancomycin. More than 130 patients will be enrolled. Patients will be treated for 7-14 days and a Test-of-Cure (TOC) visit will be performed 7-14 days after the end of therapy. The primary endpoint will be the clinical cure rate at the TOC visit.
Progress of Phase I programme with oral iclaprim
The completed Phase I study was designed as a double-blind, placebo-controlled, dose escalation trial. A total of 32 subjects participated in the study (16 males and 16 females). Safety and tolerability were evaluated after administration of supra-therapeutic doses aimed at determining the maximal tolerated dose.
No serious adverse events were reported. Only after administering five-fold the targeted therapeutic dose, the number of adverse events showed a significant increase relative to placebo and this dose was then defined as the maximal tolerated dose in humans. All reported adverse events were mild-to-moderate in nature and mainly concerned vomiting and nausea. As in previous clinical trials with iclaprim, ECG monitoring was conducted. No clinically relevant increases in the QTc interval were observed at any of the investigated doses.
A further Phase I study, investigating the safety and tolerability of multiple administration of supra-therapeutic doses of oral iclaprim is currently ongoing. In addition, slow-release administration at supra-therapeutic doses is being investigated.
"Rolling" NDA for intravenous iclaprim in cSSSI; electronic submission of first modules due before year-end 2007
Arpida has made very good progress in compiling the New Drug Application (NDA) for intravenous iclaprim in its first indication, complicated Skin and Skin Structure Infections (cSSSI). The NDA forms the basis for the U.S. Food and Drug Administration (FDA) for its evaluation of a drug candidate's eligibility for marketing approval.
Arpida has agreed with the U.S. FDA to file the NDA in a rolling process. Using a 'rolling NDA' allows the different modules within the overall package to be filed individually. Arpida has further agreed to file the NDA in an electronic format. Test data-sets have been transferred and the authorities have confirmed the receipt and navigability of the information. Both the rolling NDA and the electronic format could greatly facilitate the review process.
The first modules of the NDA package are ready and will be filed before year-end 2007. The remaining modules are expected to be transferred and filing is forecast to be completed by the end of February 2008.
Dr Khalid Islam, President and CEO of Arpida Ltd., commented: "We are pleased with the progress made across the several different programmes.
Firstly, initiation of patient enrolment in the Phase II trial with intravenous iclaprim in HAP/VAP/HCAP provides a good basis for the completion of the trial within the planned timelines. HAP/VAP/HCAP is a serious, life-threatening condition with a high medical need. We believe that iclaprim could have a high potential in this indication based on its potent and bactericidal action on MRSA and its good distribution in those lung compartments where the key respiratory pathogens reside."
Dr Islam added: "Moreover, we are very pleased with the results of the ascending dose trial with oral iclaprim, which show a good tolerability at high doses. We are now working to complete the Phase I programme while at the same time discussing with the regulatory authorities regarding the potential next steps in the development path of oral iclaprim.
Work on the NDA for intravenous iclaprim in cSSSI is progressing well. We expect to file the first modules of the package before year-end and complete the filing by the end of February 2008. After finalising the NDA filing, our next steps will focus on the preparation of the commercial launch of iclaprim."
Arpida will host a conference call to discuss these recent developments, today, 11 December 2007, at 3 pm CET. The dial-in numbers are:
The conference call (Call ID 204, followed by the #) will be available
for play-back for 48 hours after the call by dialling:
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. 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.
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 four Phase I trials. 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.
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
|SOURCE Arpida Ltd|
Copyright©2007 PR Newswire.
All rights reserved