This Phase II trial with NXL104/ceftazidime will be in hospitalizedpatients with complicated intra-abdominal infections (cIAIs). In 2007,Novexel estimates that more than 300,000 patients were treated for cIAIs inhospital in the seven major pharmaceutical markets. This estimate is based onnational databases providing hospital patient discharge data.
The primary objective of the study is to evaluate the clinical responseto NXL104/ceftazidime plus metronidazole in the treatment of adult patientswith cIAIs as compared to meropenem. This evaluation will be based on theTest of Cure visit two weeks post-therapy. The total duration of antibiotictherapy for each patient should be 5 to 14 days. The results of this studyare expected in early 2010.
This second Phase II trial in cIAIs, follows a Phase II clinical trial ofNXL104/cetazidime in hospitalized patients with complicated urinary tractsinfections (cUTIs). This study which began in November is due to complete inlate 2009.
In completed Phase I studies in healthy subjects NXL104/ceftazidime wasgenerally well tolerated and the pharmacokinetics of the two components werewell matched. Additional studies in special populations are ongoing.
Novexel retains worldwide rights on the NXL104/ceftazidime combination.
NXL104 is a novel injectable non beta lactam, beta-lactamase inhibitor,which is being developed to address the increasing problem of microbialresistance to beta lactam antibiotics (penicillins, cephalosporins,carbopenems) mediated by beta-lactamase enzymes.
NXL104 is a significant advance, as it is able to inhibit a broader rangeof beta-lactamases than currently marketed inhibitors. Its spectrum includesclass A (including ESBL and KPC) and class C enzymes. NXL104 in combinationwith ceftazidime will be targeting infections caused by Gram negativebacteria, including Enterobacteriaceae and Pseudomonas.
Novexel currently has two novel antibacterials in Phase II clinicaldevelopment. These are the injectable beta-lactamase inhibitor, NXL104, whichis being developed in combination with the cephalosporin antibioticceftazidime for serious Gram negative infections, and the oral streptograminantibiotic, NXL103, for the treatment of Gram positive infections, with afocus on treatment in the hospital setting and intravenous (IV) to oralswitch. Novexel has three further programmes in preclinical development,NXL105, a novel anti-Pseudomonal antibiotic, NXL201, a novel echinocandinantifungal agent, and NXL104 in combination with ceftaroline. This latterproduct is being developed by our partner, Forest Laboratories, solely forNorth American markets.