On June 1, 2023, Pfizer announced encouraging outcomes from its Phase III program that involved the REVISIT and ASSEMBLE trials. These studies assessed the efficacy, safety, and tolerability of a new investigational antibiotic combination called aztreonam-avibactam (ATM-AVI) in the treatment of severe bacterial infections caused by Gram-negative bacteria, including multidrug-resistant pathogens that produce metallo-β-lactamase (MBL). These pathogens pose a challenge as they have limited or no treatment options. The data collected affirms that ATM-AVI demonstrates the effectiveness and good tolerability, with no new safety concerns and a safety profile similar to that of aztreonam alone.
“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,” said James Rusnak, Senior Vice President and Chief Development Officer, Internal Medicine, Anti-Infectives and Hospital, Pfizer. “We are committed to meeting this critical need and helping to address the global health threat of antimicrobial resistance.”
“These clinical findings show that ATM-AVI, if approved, could help provide coverage against Gram-negative bacteria without compromising on efficacy or safety,” said Yehuda Carmeli, Head, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Tel Aviv, Israel. “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.”
Comprehensive findings from the research will be submitted for publication in scientific journals. The data obtained from the REVISIT and ASSEMBLE studies are anticipated to serve as the foundation for regulatory submissions planned in the European Union, United Kingdom, China, and the United States during the latter half of 2023. Pfizer possesses the worldwide commercialization rights for ATM-AVI, except for the United States and Canada, where its development partner AbbVie holds the rights.
Source: Pfizer
