By Colin Kellaher

 

Pfizer on Thursday reported positive results from a pair of Phase 3 studies evaluating the efficacy, safety and tolerability of the novel investigational antibiotic combination aztreonam-avibactam, or ATM-AVI.

The New York drugmaker, which is studying the combination in the treatment of serious bacterial infections due to antibiotic-resistant Gram-negative bacteria, said the study data support that ATM-AVI is effective and well-tolerated, with no new safety findings and a similar safety profile to aztreonam alone.

Pfizer said it expects data from studies to form the basis for planned regulatory filings in the U.S., U.K., European Union and China in the second half of the year. Pfizer holds the global rights to commercialize ATM-AVI outside of the U.S. and Canada, where development partner AbbVie holds the rights.

"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," Pfizer said.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

June 01, 2023 10:39 ET (14:39 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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