Actavis Announces Positive Results In Phase 3 Antibiotic Studies
DUBLIN - Actavis plc (NYSE: ACT) confirmed positive topline results from RECLAIM-1 and -2, pivotal Phase III studies evaluating the potential for the investigational antibiotic, ceftazidime-avibactam as a treatment for adult hospitalized patients with complicated intra-abdominal infections.
Ceftazidime-avibactam consists of a cephalosporin (ceftazidime), an established treatment for serious bacterial infections, and a next generation non-beta lactam beta-lactamase inhibitor (avibactam). The compound is being developed to treat a broad range of Gram-negative bacterial infections, which are becoming resistant to antibiotics and pose an increasing threat to public health. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.
The global RECLAIM-1 and RECLAIM-2 Phase III studies both evaluated the safety and efficacy of ceftazidime-avibactam, administered intravenously as a two hour infusion (2000 mg / 500 mg) plus metronidazole, compared to meropenem, administered intravenously as a 30-minute infusion (1 g), in hospitalized adult patients with complicated intra-abdominal infections. Data from the RECLAIM-1 and RECLAIM-2 studies were analyzed as a single-pooled dataset with the agreement of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
In the RECLAIM-1 and RECLAIM-2 Phase III studies, ceftazidime-avibactam met the objective of statistical non-inferiority compared to meropenem. The primary endpoint was a clinical cure rate 28 to 35 days after randomization (the Test of Cure visit). Also, ceftazidime-avibactam was effective in treating cIAI patients infected with ceftazidime-resistant bacteria.
The most commonly reported adverse events for ceftazidime-avibactam in combination with metronidazole were diarrhea, nausea, vomiting and fever.
"We are very pleased by these results, which support the potential of ceftazidime-avibactam as a new treatment option for patients with these serious and life-threatening intra-abdominal infections," said David Nicholson,PhD, Senior Vice President, Actavis Global Brands R&D.
"As a result of limited available options, infections due to antibiotic resistant Gram-negative bacteria are becoming increasingly more difficult to treat. New agents are needed and ceftazidime-avibactam could be a welcome addition for physicians who manage high-risk patients with these hard to treat infections," said Keith Kaye, MD, Professor of Medicine in the division of infectious disease at Wayne State University Hospital in Detroit, Mich.
Ceftazidime-avibactam is being jointly developed with Astra Zeneca. Forest Laboratories LLC., a subsidiary of Actavis plc, holds the rights to commercialize ceftazidime-avibactam inNorth America, while AstraZeneca holds the rights to commercialize ceftazdime-avibactam in the rest of the world.