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– First clinical trial to specifically study confirmed carbapenem-resistant Acinetobacter infections–
– Phase 3 top-line data readout now anticipated in early 4Q 2021 –
WALTHAM, Mass. and SHANGHAI, China and SAN FRANCISCO, July 27, 2021 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ:ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, and Zai Lab Limited (NASDAQ:ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, announced today that patient enrollment in the ATTACK Phase 3 registrational clinical trial of sulbactam-durlobactam (SUL-DUR) is now complete, with top-line data readout anticipated early in the fourth quarter of 2021.
David Altarac, M.D., Chief Medical Officer at Entasis, commented, “Completion of ATTACK enrollment is a significant milestone for our companies, and we thank the patients and their families, healthcare professionals and our partner, Zai Lab, for the collective efforts that enabled us to reach full enrollment during these challenging times. To our knowledge, ATTACK is the largest antibiotic-resistant, pathogen-specific registrational trial to be conducted globally and the first to focus specifically on carbapenem-resistant Acinetobacter infections. We look forward to announcing top-line data in the coming months.”
Harald Reinhart, M.D., Chief Medical Officer for Autoimmune and Infectious Diseases at Zai Lab, stated, “Infections caused by carbapenem-resistant Acinetobacter spp. (CRAB) are extremely difficult to manage and associated with high mortality, as safe and effective antibiotics against such strains are often no longer available. In many countries, including China, this problematic pathogen is frequently isolated from patients in the ICU setting. We believe that SUL-DUR is uniquely suited to address this high unmet medical need and are proud that Chinese clinical centers contributed significantly to the ATTACK trial.”
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 China. Part B of the trial, which enrolled over 25 patients, is a non-randomized cohort of patients with confirmed Acinetobacter infections that are treated with SUL-DUR but are not eligible for Part A due to factors that could include colistin resistance, colistin intolerance or Acinetobacter infection in another body site unresponsive to colistin therapy.
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 April 2019. ATTACK is a global Phase 3 registration trial that enrolled patients at clinical sites from 17 countries.
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 the United States, Europe, the Middle East and China for which significant morbidity and mortality exists due to limited treatment options.
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 U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Forward-looking statements contained in this announcement are made as of this date, and except as required by law, Entasis assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.