Arpida Ltd. has announced that it has received approval from the US Food and Drug Administration for a Phase II trial with intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.
According to US data, pneumonia accounts for approximately 15% of all hospital-associated infections and 27% of all infections acquired in the intensive care unit; moreover it has a high mortality rate. The number of treatment options in this field is currently very limited, particularly for infections caused by methicillin-resistant Staphylococcus aureus (MRSA). This has given rise to a large and urgent medical need for safe drugs which are efficacious against these resistant pathogens.
Results of a special Phase I study, conducted in 2005, have shown that iclaprim achieves high concentrations in the specific compartments of the lung where clinically relevant pathogens, including MRSA, are most commonly found and could therefore become an efficacious drug for the treatment of pneumonia.
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. Enrolment is expected to start in the second half of 2007.
Intravenous iclaprim is also being developed for complicated skin and skin structure infections (cSSSI). In this indication the drug candidate has completed patient enrolment in two pivotal Phase III trials. The first of the two studies has already been evaluated and shows a good efficacy in cSSSI as well as excellent safety. Top-line data of the second trial are expected shortly. If these confirm the strong results of the first trial, an NDA filing can be expected before the end of this year.
Dr. Paul Hadvary, Head of Development of Arpida Ltd, commented: "Based on our positive results with iclaprim in cSSSI trials and on its good tissue distribution particularly to the key lung compartments, we feel that this compound could demonstrate good efficacy in hospital-acquired, ventilator- and healthcare-associated pneumonia. I am pleased that the US FDA has consented that we initiate studies in these seriously ill patients as I believe that iclaprim could add a potent weapon to the clinicians' armamentarium to combat this potentially life-threatening infection."
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.