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Entasis Anticipates First FDA Approval Of Pathogen-Specific Antibacterial

 
• By Joseph Haas

With Phase III data showing non-inferiority to colistin, as well as nephrotoxicity superiority, Entasis thinks sulbactam/durlobactam will provide a new standard of care and succeed where Achaogen’s Zemdri failed.

Antibiotic-resistant-bacteria
Entasis tested its combo antibacterial against colistin

Entasis Therapeutics Holdings Inc. thinks the Phase III data for its combination anti-infective therapy SUL-DUR against carbapenem-resistant Acinetobacterbaumannii infections will position it to earn the first pathogen-specific indication for an antibiotic and enable it to succeed where Achaogen, Inc.’s Zemdri (plazomicin) failed several years earlier.

Entasis, which spun out from AstraZeneca PLC in 2015, reported top-line Phase III data on 18 October showing non-inferiority for the combination of the generic polymyxin antibiotic sulbactam with the novel beta-lactamase inhibitor durlobactam (SUL-DUR) compared to the standard of care, the polymyxin antibiotic colistin, for 28-day, all-cause mortality in

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