Entasis Therapeutics and Zai Lab Complete Patient Enrollment in the ATTACK Phase 3 Registrational Clinical Trial of Sulbactam-Durlobactam
– First clinical trial to specifically study confirmed carbapenem-resistant Acinetobacter infections–
– Phase 3 top-line data readout now anticipated in early 4Q 2021 –
ATTACK is a Phase 3 registrational trial that will evaluate the safety and efficacy of SUL-DUR in patients with confirmed carbapenem-resistant Acinetobacter infections. Part A of the trial, which evaluates the efficacy of SUL-DUR compared to colistin on a background of imipenem in patients with pneumonia and/or bloodstream infections, with 28-day all-cause mortality as the primary efficacy endpoint, has now enrolled over 120 patients, sufficient to complete the trial. Approximately one-quarter of the patients in Part A, the primary efficacy arm of the trial, were enrolled in
About Sulbactam-Durlobactam (SUL-DUR)
SUL-DUR is an intravenous, or IV, investigational drug that is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a novel broad-spectrum IV β-lactamase inhibitor, or BLI, that we are developing for the treatment of infections caused by Acinetobacter baumannii, including carbapenem-resistant strains. We initiated ATTACK, our Phase 3 registration trial, in
Acinetobacter is a Gram-negative, opportunistic human pathogen that predominantly infects critically ill patients often resulting in severe pneumonia and bloodstream infections, but can also infect other body sites such as the urinary tract and the skin. Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance at rates not previously seen in other bacteria. Based on current carbapenem resistance rates, we estimate there are in excess of 250,000 hospital-treated carbapenem-resistant Acinetobacter infections annually across
Entasis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ pathogen-targeted design platform has produced a pipeline of product candidates, including sulbactam-durlobactam (targeting Acinetobacter baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae infections), ETX0282CPDP (targeting Enterobacteriaceae infections) and ETX0462 (targeting Pseudomonas infections). For more information, visit www.entasistx.com.
Entasis Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Entasis’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during non-clinical or clinical studies, clinical site activation rates or clinical trial enrollment rates that are lower than expected and changes in expected or existing competition, changes in the regulatory environment, failure of Entasis’ collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Many of these factors are beyond Entasis’ control. These and other risks and uncertainties are described more fully in the Entasis’ filings with the
Source: Entasis Therapeutics Holdings Inc.