Friday, June 02, 2023
Pfizer Inc. has announced positive results from its Phase 3 program, comprising the REVISIT and ASSEMBLE studies, which evaluated the efficacy, safety, and tolerability of the novel antibiotic combination aztreonam-avibactam (ATM-AVI). The trials focused on treating severe bacterial infections caused by Gram-negative bacteria, including multidrug-resistant pathogens for which limited or no treatment options are available.
According to Pfizer, the data supports that ATM-AVI is effective and well-tolerated, with a safety profile similar to aztreonam alone. The company believes that if approved, ATM-AVI could be an important treatment option for patients with life-threatening bacterial infections that are resistant to most currently available antibiotics.
The REVISIT study compared ATM-AVI ± metronidazole (MTZ) with meropenem (MER) ± colistin (COL) for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP). The results showed high cure rates for both treatment arms in patients with cIAI and HAP/VAP. The incidence of serious adverse events was similar between the two groups.
In the ASSEMBLE study, which focused on patients with infections caused by MBL-producing Gram-negative bacteria, ATM-AVI demonstrated a higher cure rate compared to the best available therapy (BAT) group.
Antimicrobial resistance, particularly in Gram-negative bacteria, is a significant global health threat. The positive outcomes of Pfizer's Phase 3 studies offer hope for addressing multidrug-resistant infections by providing new treatment possibilities.
Pfizer plans to submit the full results of the studies for scientific publication and expects to file for regulatory approvals in the European Union, United Kingdom, China, and the U.S. in the second half of 2023. Pfizer holds the global rights to commercialize ATM-AVI outside of the United States and Canada, where AbbVie has the rights.
The studies were sponsored by Pfizer and received funding from federal sources, including the U.S. Department of Health and Human Services. They were also supported by public-private partnerships, such as the Innovative Medicines Initiative and the Biomedical Advanced Research and Development Authority.