Entasis Therapeutics (NASDAQ:ETTX) has initiated a Phase 3 pivotal clinical trial to evaluate ETX2514 and sulbactam (ETX2514SUL) for the treatment of carbapenem-resistant A. baumannii infections.
A. baumannii causes severe infections, including pneumonia, and is associated with high mortality. ETX2514 is a broad-spectrum inhibitor of beta-lactamase, an enzyme produced by bacteria that provides resistance to certain antibiotics, including carbapenem.
“More than 60% of A. baumannii strains tested in the United States in 2016 were resistant to carbapenems, and in some European and Asian countries carbapenem resistance surpasses 80%. ETX2514SUL offers a precision, pathogen-targeted, approach to the treatment of A. baumannii,” Robin Issacs, Enatsis’ CMO, said in a statement.
The trial will enroll 300 patients from 18 countries. Entasis believes that this trial alone could be sufficient to support the filing of an NDA in both the U.S. and Europe, and expects to report top-line data in the second half of 2020.