Pfizer posts promising Phase 3 data for AbbVie-partnered antibiotic

Pfizer (NYSE:PFE) announced Thursday that the antibiotic combo aztreonam-avibactam (ATM-AVI) it co-develops with AbbVie (NYSE:ABBV) was effective and well tolerated in two Phase 3 trials against infections caused by Gram-negative bacteria.
Citing data from REVISIT and ASSEMBLE studies sponsored by Pfizer (PFE) with funding from the U.S. government, the company said that the drug combination indicated no new safety signals and its safety profile matched that of anti-bacterial injection aztreonam.
In the REVISIT study, ATM-AVI with or without metronidazole (MTZ) outperformed meropenem (MER) ± colistin in terms of the cure rates and 28-day mortality rates against a range of bacterial infections.
The ASSEMBLE study evaluated the effects of ATM-AVI against infections due to a muti-drug-resistant pathogen called metallo-β-lactamase-producing Gram-negative bacteria. In that trial, those on ATM-AVI with or without MTZ showed a better cure rate than those on the best available therapy.
The results have yet to undergo peer review, which typically precedes publication in a medical journal. The company expects to submit regulatory filings for ATM-AVI in the EU, U.S., China, and the U.K. in H2 2023 with data from REVISIT and ASSEMBLE studies.
Pfizer (PFE) holds rights to market ATM-AVI globally except in the U.S. and Canada, where AbbVie (ABBV) has rights for marketing.

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