Pfizer Inc ((PFE)), Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.
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Pfizer Inc. and AbbVie are conducting a clinical study titled ‘A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT.’ The study aims to assess the safety and effects of the combination drug Aztreonam-Avibactam (ATM-AVI) in treating gram-negative bacterial infections in infants and newborns.
The intervention involves administering ATM-AVI, a combination of an antibiotic and a resistance inhibitor, to hospitalized infants. The study is divided into two parts: Part A tests a single dose, while Part B involves multiple doses to evaluate safety, tolerability, and pharmacokinetics.
This open-label, non-randomized study includes two parts with four age cohorts each, focusing on basic science. There is no masking, and the study aims to gather data on the safety and pharmacokinetics of ATM-AVI in young patients.
The study began on September 25, 2024, with the last update submitted on August 4, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates to stakeholders.
This study could significantly impact Pfizer and AbbVie’s market positions by potentially expanding their portfolios with a new pediatric antibiotic treatment. Positive outcomes may boost investor confidence and influence stock performance, especially in the competitive pharmaceutical sector.
The study is currently recruiting, with further updates available on the ClinicalTrials portal.