Novexel has initiated Phase II clinical trial for advanced oral antibacterial NXL103 (flopristin/linopristin) in adults with acute bacterial skin and skin structure infections (ABSSSI). The trial is designed to assess the safety and efficacy of NXL103 in comparison to oral linezolid.
Novexel said that the comparative Phase II trial with NXL103 is a prospective, multicenter, investigator-blinded, two-arm, parallel group study carried out in adults, either in hospital or as outpatients, with ABSSSI. In the study, the patients will be randomised to receive either NXL103 (500mg twice a day) or linezolid (600mg twice a day), with 120 patients receiving NXL103 and 60 receiving linezolid. The treatment period in both study arms will be between 10 and 14 days.
The primary endpoint of the study is the clinical outcome in the clinically evaluable population at the test of cure (TOC) visit (7 days post-therapy). Secondary end points of the study include microbiological response at the TOC visit as well as evaluating the tolerability and safety of NXL103.
The Phase II study is expected to recruit a total of 180 patients from approximately 20 sites in the US and Central America and is expected to be completed in 2010. It is a critical part of Novexel’s clinical development plan for NXL103 which is focused on its potential to be used in hospitals and out-patients as an oral agent for the treatment of infections caused by Gram-positive organisms, including MRSA.
NXL103, as a member of the Streptogramin class of antibiotics, has a unique mode of action, with its two components acting synergistically to inhibit the bacterial ribosome. Its spectrum of activity indicates its potential to be effective in the treatment of ABSSSI, including those caused by resistant pathogens such as MRSA.
Iain Buchanan, CEO of Novexel, said: “The start of this Phase II trial with NXL103 is another important step in the growth of the company. There is a clear need for products that can be used to manage the release of patients from hospital by allowing them to be switched from intravenous to oral therapy.”