Arpida ready for global Phase III clinical trial
Arpida, a Swiss anti-infectives company, has received clearance from the FDA to conduct Phase III clinical trials for its lead product candidate, injectable iclaprim, in the US.
Arpida, a Swiss anti-infectives company, has received clearance from the FDA to conduct Phase III clinical trials for its lead product candidate, injectable iclaprim, in the US.
The decision will allow Arpida to include US centres in the planned global Phase III trial programme with injectable iclaprim in patients suffering from complicated skin and skin structure infections (cSSSI).
Iclaprim is a novel diaminopyrimidine that has demonstrated potent activity against a broad spectrum of bacterial pathogens, including MRSA (methicillin-resistant Staphylococcus aureus). Iclaprim is rapidly bactericidal and penetrates well into tissues and is being developed for treatment of severe hospital infections arising from infected burns, ulcers and surgical wounds; infections that often include those multidrug-resistant bacteria, such as MRSA.
The Phase III ASSIST study (Arpida's Skin and Skin Structure Infection STudy) is designed to investigate the efficacy and safety of iclaprim compared with linezolid (marketed as Zyvox). This multinational study will enrol patients in the US, Canada and several European countries. Dr Dennis Stevens, Infectious Diseases Section of the Veterans Affairs Medical Center, Boise, Idaho, will be a lead investigator in the Phase III ASSIST study. Dr Stevens has been involved in a large number of clinical trials of hospital antibiotics.
Dr Khalid Islam, president and ceo of Arpida, said: 'Clearance from the FDA is a key development milestone for Arpida as it enables us to kick off our global Phase III programme for iclaprim. We believe that iclaprim could play a significant role in the treatment of hospital infections in the years to come. We are confident that our Phase III studies will establish the efficacy of iclaprim in the treatment of difficult-to-treat cSSSI, including those caused by MRSA.'
In recent years, bacteria have increasingly become resistant to many, if not all, currently available antibiotics. Particularly in the hospital environment, but increasingly also in the community, antibiotic drug resistance has become a major cause of morbidity, mortality and increased healthcare costs. It has been shown for example, that around 70% of patients who acquire an infection in a U.S. hospital, have infections resistant to at least one antibiotic. The antibacterial market is estimated at more than US$26bn with hospital antibiotics representing approximately 30% of this figure.