Pfizer has announced positive phase 3 results supporting the safety and efficacy of its investigational antibiotic combination, aztreonam-avibactam (ATM-AVI), in treating serious infections caused by multi-drug resistant, gram-negative bacteria.

Declared by the World Health Organization as one of the top ten threats to global health, antimicrobial resistance occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time. As a result, infections become harder to treat and the risk of disease spread, severe illness and death increases.

Pfizer’s late-stage programme included a study which compared ATM-AVI and metronidazole with two older antibiotics – meropenem and colistin – for the treatment of complicated intra-abdominal infections, hospital-acquired pneumonia and ventilator-associated pneumonia.

For patients with complicated intra-abdominal infections, the cure rate was 76.4% in the ATM-AVI plus metronidazole treatment group, versus 74% in the meropenem and colistin cohort.

Additionally, for patients with hospital-acquired pneumonia and ventilator‐associated pneumonia, the cure rate was 45.9% with Pfizer's combination plus metronidazole, versus 41.7% for meropenem and colistin.

The company added that these results are further supported by a second study in the phase 3 ATM-AVI programme, which found that 41.7% of patients in the ATM-AVI plus metronidazole treatment arm who had infections due to confirmed MBL-producing gram-negative bacteria were cured, versus 0% of those on best available therapy.

ATM-AVI patients experienced treatment emergent adverse events that were in line with those of aztreonam alone, Pfizer said, and no ATM-AVI patients experienced serious adverse events related to treatment.

James Rusnak, senior vice president and chief development officer, internal medicine, anti-infectives and hospital, Pfizer, said: “We believe this data demonstrates 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.”

Full results from the studies will be submitted for scientific publication, Pfizer said, and are expected to form the basis for planned regulatory filings in the EU, UK, US and China later this year.

Reference：
https://www.pmlive.com/pharma_news/pfizers_antibiotic_combination_shows_promise_in_treating_multi-drug_resistant_infections_1492321