Pfizer antibiotic glows in phase 3 trials

June 2, 2023

This week, Pfizer announced positive results from a phase 3 trial evaluating its novel antibiotic combination for multi-drug resistant bacteria, aztreonam-avibactam (ATM-AVI).

Annually, over 1.2 million individuals globally die from antibiotic-resistant infections. Without intervention, analysts say that by 2050, this figure could skyrocket to 10 million deaths per year.

Pfizer’s antibiotic was evaluated for the treatment of serious bacterial infections due to Gram-negative bacteria — including metallo-β-lactamase (MBL)-producing multidrug-resistant pathogens for which there are limited or no treatment options — in a phase 3 trial called REVISIT. 

The REVISIT study was a prospective, randomized, multicenter, open-label study with a parallel group comparative design that included 422 hospitalized adult patients from 81 different locations across 20 countries.

The trial compared the effectiveness of ATM-AVI with or without metronidazole (MTZ) to meropenem (MER) with or without colistin (COL) in treating complicated intra-abdominal infections, hospital-acquired pneumonia, and ventilator-associated pneumonia. Overall, all-cause 28-day mortality rates were low and comparable between the treatment groups and ATM-AVI ± MTZ was well-tolerated, with a safety profile similar to that of aztreonam alone.

“These data are particularly promising given the complexities of managing cIAI and HAP/VAP infections in these hospitalized, critically ill patients, and the challenges of real-world patient recruitment within this population,” said Yehuda Carmeli, Head, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Tel Aviv, Israel.