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The iclaprim NDA contains data from 15 clinical studies, including twoadequate and well-controlled multinational pivotal Phase III trials (ASSIST-1and ASSIST-2, in which approximately 1,000 patients were enrolled andtreated). Patients enrolled in both Phase III trials exhibited highincidences of methicillin-resistant Staphylococcus aureus (MRSA). In thesetwo independent Phase III trials, intravenous iclaprim achieved thepre-specified primary endpoint. In the studies, iclaprim was well-toleratedwith a safety profile which was compatible with treatment of patients withcSSSI.
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Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "We areconvinced that iclaprim - if approved - has the properties to become asuccessful drug in the hospital antibiotics market. In this market there is aclear need for novel therapies, as several of the currently available drugsare faced with reduced efficacy, emerging resistance or worrying sideeffects."
Dr Khalid Islam, President and CEO of Arpida Ltd. added: "We're veryproud of reaching this important milestone. Arpida has successfullyprogressed iclaprim from an early preclinical stage all the way to regulatoryfiling. This achievement is a credit to our team at Arpida as well as to ourexternal partners. We look forward to working closely with the FDA on theirreview of our submission."
In addition to the cSSSI indication, intravenous iclaprim is also beingdeveloped for the treatment of patients with hospital-acquired pneumonia(HAP), ventilator-associated pneumonia (VAP) or healthcare-associatedpneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.This programme is currently in Phase II. Moreover, an oral formulation oficlaprim is currently in Phase II clinical trials as a potential step-downtherapy following initial intravenous treatment.
About Arpida Ltd.
Arpida (SWX: ARPN) is a biopharmaceutical company with researchfacilities in Reinach, Switzerland and in the USA. It focuses on thediscovery and development of novel drugs that seek to overcome the growingproblem of microbial resistance. The most advanced compounds include anantibacterial under regulatory review and an antifungal in Phase III.
Arpida's leading product candidate is intravenous iclaprim, a potentantibacterial that targets severe infections requiring hospital treatment,including those caused by methicillin-resistant Staphylococcus aureus (MRSA).The clinical programme for the first indication, complicated skin and skinstructure infections (cSSSI), has been completed. The submission of the NDAto the US FDA was completed in March 2008.
In December 2007, Arpida announced the enrolment of the first patients ina Phase II clinical study with intravenous iclaprim in the treatment ofpatients with hospital-acquired pneumonia (HAP), ventilator-associatedpneumonia (VAP) or healthcare associated pneumonia (HCAP).
In January 2008, the US FDA granted authorisation to progress oraliclaprim into a Phase II 'intravenous-to-oral' switch trial. Iclaprim couldbe offered not only as an intravenous therapy for hospital use in acutesituations, but also as an oral formulation, allowing early patient dischargefollowed by outpatient treatment. This switch could be a valuable instrumentin reducing healthcare costs and enhancing patient comfort.
Arpida's fourth most adva
