HQ Team
June 1, 2023: Pfizer’s last-stage experimental trials for treating multi-drug-resistant bacteria have yielded positive results, the US-based company announced.
The Phase III clinical trials were conducted in 422 hospitalized adult patients across 81 locations in 20 countries. The combination drug aztreonam-avibactam (ATM-AVI) was “effective and well-tolerated,” according to Pfizer.
Antimicrobial resistance, particularly in gram-negative bacteria, has been widely recognized as one of the biggest threats to global health.
Gram-negative bacteria cause infections, including pneumonia, bloodstream infections, wound or surgical site infections, and meningitis in healthcare settings.
They are resistant to multiple drugs and are increasingly resistant to most available antibiotics. These bacteria have built-in abilities to find new ways to be resistant and can pass along genetic materials that allow other bacteria to become drug-resistant as well.
Resistance to all antibiotics
“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, Chief Development Officer, Internal Medicine, Anti-Infectives and Hospital at Pfizer.
The cure rate was 85.1% for ATM-AVI drug compared with meropenem and colistin combination for patients with complicated intra-abdominal infections, while it was 46.7% compared to 54.5% in patients with hospital-acquired pneumonia, and ventilator-associated pneumonia.
A second supportive study confirmed higher ratings for ATM-AVI when compared with the best available therapy, according to a Pfizer statement. Data supported that “no new safety findings and a similar safety profile to aztreonam alone.”
“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 of the National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center based in Israel.
Jointly made with AbbVie
ATM-AVI is being jointly developed with AbbVie. Pfizer holds the global rights to commercialize this investigative therapy outside of the US and Canada, where the rights are held by AbbVie.
Data from the studies are expected to form the basis for planned regulatory filings in the European Union, United Kingdom, China, and the US in the second half of 2023.
In 2019, about 1.27 million deaths were caused globally by bacterial anti-microbial resistance. Without solutions, a continued rise of AMR could make routine medical procedures too risky to perform.
These studies were funded in whole or part with federal funds from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.
