AstraZeneca has reported positive top-line results from the phase three studies deployed to investigate the potential of the antibiotic ceftazidime-avibactam (CAZ-AVI) to treat hospitalised adult patients with complicated intra-abdominal infections (cIAI).
CAZ-AVI is composed of cephalosporin (ceftazidime), an established treatment for serious bacterial infections and a next-generation non-beta lactam beta-lactamase inhibitor (avibactam).
The RECLAIM-1 and RECLAIM-2 phase three studies have evaluated the safety and efficacy of CAZ-AVI, which is under development with AstraZeneca to treat wide range of gram-negative bacterial infections that are becoming resistant to antibiotics.
AstraZeneca chief medical officer and global medicines development executive vice-president Briggs Morrison said: "We are very encouraged by these results which highlight the potential for CAZ-AVI to provide a much-needed new treatment option for serious and life-threatening intra-abdominal infections, especially where antibiotic resistance poses a threat to treatment."
In the studies, CAZ-AVI was administered intravenously as a two hour infusion (2,000mg / 500mg) plus metronidazole, compared to having meropenem administered intravenously as a 30 minute infusion (1g), in hospitalised adult patients with complicated intra-abdominal infections.
Following the agreement with US Food and Drug Administration (FDA) and European Medicines Agency (EMA), the date from the RECLAIM-1 and RECLAIM-2 studies were analysed as a single-pooled dataset.
CAZ-AVI has reached the objective of statistical non-inferiority compared to meropenem in both the phase three studies.
In addition, studies are initiated for CAZ-AVI in complicated urinary tract infections (cUTI), nosocomial pneumonia and for the treatment of cIAI and cUTI patients with ceftazidime-resistant infections.
AstraZeneca, along with Actavis’ wholly owned subsidiary Forest Laboratories, is developing CAZ-AVI. AstraZeneca holds the global rights to commercialise CAZ-AVI, while Forest holds the rights for North America.