Novexel initiates second Phase II intra-abdominal infections trial

Novexel, a specialty pharmaceutical company, has announced that its most advanced injectable antibacterial, which combines the company’s broad spectrum beta lactamase inhibitor, NXL104, with the well established cephalosporin antibiotic, ceftazidime, has entered a second Phase II clinical trial.

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 II trial with NXL104/ceftazidime will be in hospitalized patients with complicated intra-abdominal infections (cIAIs).

This Phase II trial is a prospective, multicenter, double-blind, randomized study which is designed to evaluate the efficacy, safety, and tolerability of NXL104/ceftazidime plus metronidazole versus meropenem in the treatment of adults with cIAIs. 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 five to 14 days. The results of this study are expected in early 2010.

Iain Buchanan, CEO of Novexel, said: NXL104 has the ability to inhibit the activity of a broader range of clinically important beta-lactamases than currently marketed beta-lactam inhibitors and we believe that this combination product could provide an important new treatment option in the hospital.