A late-stage study has confirmed the efficacy of AstraZeneca's new combination antibiotic Zavicefta in patients with hospital acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).
The Phase III REPROVE trial successfully met its primary objective of statistical non-inferiority compared to meropenem at the test of cure visit (day 21 from randomisation), according to the firm.
The drugmaker also said the data show that all-cause mortality rate at day 28 from randomisation was also similar in the two groups, while no new safety signals were thrown up during the trial.
Zavicefta was cleared by European regulators in June to treat patients with serious Gram-negative bacterial infections requiring hospitalisation, based on a reduced volume of clinical data, which included results from three Phase III studies in complicated intra-abdominal infections; Phase II and III studies in complicated urinary tract infections; and data from a Phase I study for HAP/VAP.
The treatment is comprised of avibactam, a first-in-class broad-spectrum β-lactamase inhibitor, which protects ceftazidime against degradation by Class A, C and some D β-lactamases, and ceftazidime, a third generation antipseudomonal cephalosporin with a well-established efficacy and safety profile.
Resistance to cephalosporins and other antibiotics is on the rise, in particular in Gram-negative bacteria; by inhibiting the action of beta-lactamases, which play a key role in the development of bacterial resistance to such antibiotics, avibactam restores the activity of ceftazidime.
"The positive results from this important Phase III trial validate our science-led approach and confirm the effectiveness of Zavicefta in treating hospital-acquired pneumonia, providing patients and physicians with a much-needed new treatment option in the fight against antibiotic-resistant pathogens," noted Hans Sijbesma, Managing Director of AstraZeneca's Antibiotics Business Unit.
Zavicefta is being jointly developed by AstraZeneca and Allergan; AstraZeneca holds the global commercialisation rights, with the exception of North America, where the rights are held by its partner.
AZ said it would present full results from the REPROVE trial at future scientific meetings.