Novexel announced that its most advanced injectable antibacterial, which combines Novexel’s broad-spectrum beta-lactamase inhibitor, NXL104, with the established cephalosporin antibiotic, ceftazidime, has entered a second Phase 2 clinical trial.
The trial with NXL104/ceftazidime will be in hospitalized patients with complicated intra-abdominal infections (cIAIs). NXL104/ceftazidime is being developed to treat hospital infections that are caused by Gram-negative bacteria, including those resistant to many currently used antibiotics. This Phase 2 trial is a prospective, multicenter, double-blind, randomized study which is designed to evaluate the efficacy, safety, and tolerability of NXL104/ceftazidime plus metronidazole vs. meropenem (Merrem or Meronem, AstraZeneca) in the treatment of adults with cIAIs. Complicated intra-abdominal infections include those infections requiring surgical intervention and which extend beyond the hollow viscus into the peritoneal space. A total of approximately 200 patients will be enrolled, with 100 patients being included in each treatment arm.
The primary objective of the study is to evaluate the clinical response to NXL104/ceftazidime plus metronidazole in the treatment of adult patients with cIAIs as compared to meropenem. This evaluation will be based on the Test of Cure visit two weeks post-therapy. The total duration of antibiotic therapy for each patient should be 5 to 14 days. The results of this study are expected in early 2010.
This second Phase 2 trial in cIAIs, follows a Phase 2 clinical trial of NXL104/cetazidime in hospitalized patients with complicated urinary tracts infections (cUTIs). This study which began in November is due to complete in late 2009.
In completed Phase 1 studies in healthy subjects NXL104/ceftazidime was generally well tolerated and the pharmacokinetics of the two components were well matched. Additional studies in special populations are ongoing.
Under an independent development program, Forest Laboratories will combine NXL104 in a treatment regimen with Forest’s ceftaroline, a novel, bactericidal injectable broad-spectrum cephalosporin. Ceftaroline is being developed as a therapeutic agent for the treatment of gram-positive pathogens including methicillin-resistant Staphylococcus aureus (MRSA), and multi-drug resistant Streptococcus pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline is being studied as a monotherapy in Phase 3 clinical trials by Forest. In January 2008, Novexel granted Forest a license to develop, manufacture and commercialise NXL104, only in combination with ceftaroline, in North America.
Date: March 3, 2009
Source: Novexel
