In phase 3 studies, the company’s investigational therapy, aztreonam-avibactam (ATM-AVI), had favorable results over other treatments used for complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP).
Pfizer recently reported results from its phase 3 program comprising the REVISIT and ASSEMBLE trials for its novel combination antibiotic, aztreonam-avibactam (ATM-AVI), which showed a therapeutic benefit and had a favorable safety profile when treating serious bacterial infections due to Gram-negative bacteria, including metallo-β-lactamase (MBL)-producing multidrug-resistant pathogens.
ATM-AVI combines aztreonam, a monobactam β-lactam, with avibactam, a recent broad-spectrum β-lactamase inhibitor. The combination of aztreonam with avibactam restores aztreonam’s activity against bacteria that co-produce MBLs and other β-lactamases
“We believe these data demonstrate that ATM-AVI, if approved, could be an important treatment option for patients with life-threatening bacterial infections that are resistant to almost all currently available antibiotics,” James Rusnak, senior vice president and chief development officer, Internal Medicine, Anti-Infectives and Hospital, Pfizer, said in a statement. “We are committed to meeting this critical need and helping to address the global health threat of antimicrobial resistance.”
The REVISIT study compared ATM-AVI ± metronidazole (MTZ) with meropenem (MER) ± colistin (COL) for the treatment of cIAI, HAP, and VAP.
The topline data from the study included:
For the ASSEMBLE study, 5/12 (41.7%) of the ATM-AVI ± MTZ patients with infections due to confirmed MBL-producing Gram-negative bacteria were cured at TOC versus 0/3 (0%) of those on best available therapy (BAT). ATM-AVI patients experienced TEAEs that were in line with those of aztreonam alone. No patient treated with ATM-AVI experienced a treatment-related SAE.
The company is planning to provide its full results from the studies in a future scientific publication. And Pfizer is planning regulatory filings in the European Union, United Kingdom, China, and the US in the second half of 2023.