In March, patient enrolment in ASSIST-2, the second pivotal Phase III trial with iclaprim in complicated skin and skin structure (cSSSI) was completed. Top-line results were published on 15 July 2007. These showed that the pre-specified primary endpoint of the second trial was achieved, as it was in the first.
The next step will be to discuss the data with the regulatory authorities and define the path forward for the filing of a New Drug Application (NDA) which is expected to take place in the course of this year.
Intravenous iclaprim - Additional indications
In June 2007, the US FDA granted authorisation to initiate 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. Results of this trial are expected in the course of 2008.
Additional Phase I trials are currently ongoing. After completion of these trials, efficacy trials could be undertaken.
In July 2007, Arpida announced the acquisition of TLT Medical Ltd., a Swiss privately-owned biopharmaceutical company with an innovative onychomycosis (OM) therapy. European regulatory authorities have granted authorisation to initiate a pivotal Phase III clinical trial that aims to demonstrate superiority of the TLT therapy compared to the standard of care topical treatment for mild to moderate OM. Enrolment is expected to start in the short term and filing for approval could be expected in late 2008 or early 2009.
AR-709 First-in-man successfully completed
AR-709 originates from Arpidas own drug discovery efforts. It is a
bactericidal antibiotic that is being developed for the treatment of upper
and lower respiratory tract infections co
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