Entasis Therapeutics Presents Data Highlights from Phase 3 ATTACK Trial at 2022 American Thoracic Society Annual Conference
WALTHAM, Mass., May 17, 2022 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (Nasdaq: ETTX), a late-stage clinical biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced that the company presented data highlights from its pivotal Phase 3 ATTACK trial at the American Thoracic Society (ATS) annual conference, held this week from May 16-18, 2022, in San Francisco, California.
The poster presentation―P628 Sulbactam-Durlobactam (SUL-DUR) Treatment Is Associated with Lower Mortality from Index Acinetobacter Infections in the Attack Phase 3 Registrational Trial―presented key data from the landmark ATTACK trial. Sulbactam-durlobactam is an investigational drug in development for the treatment of infections caused by Acinetobacter baumannii including carbapenem-resistant and multi-drug resistant strains.
Key findings in this presentation include:
- There was a notable divergence in all-cause mortality between days 6-14 with higher rates of mortality in the colistin treatment arm. All-cause mortality rates were similar in the SUL-DUR and colistin arms during days 0-5 and 15-28 after the start of therapy
- Twice as many deaths occurred in the colistin arm than in the SUL-DUR arm through Day 28
- Investigator-assessed deaths related to the index carbapenem-resistant Acinetobacter baumannii-calcoaceticus infection occurred more frequently during days 6-14 in the colistin arm
- Patients in the colistin arm who died during days 6-14 (60 ± 16 years) were younger than patients who died during days 0-5/15-28 (78 ± 12 years)
- These observations suggest that deaths early in treatment were more attributed to failure of treatment of Acinetobacter while deaths later in treatment were due to underlying co-morbidities
“We are pleased to share data from our Phase 3 ATTACK trial at ATS 2022, the first time we presented these highlights at a medical congress of pulmonary and critical care specialists,” said Manos Perros, Chief Executive Officer at Entasis Therapeutics. “Physicians in the critical care setting have limited options when treating patients with hospital acquired infections so we expect this data to be of keen interest for this audience.”
The ATTACK trial was conducted to evaluate the efficacy and safety of SUL-DUR versus colistin, both in combination with imipenem/cilastatin, for patients with Acinetobacter baumannii-calcoaceticus (ABC) infections, including carbapenem-resistant and multidrug-resistant strains. The trial consisted of two parts: Part A was a randomized, blinded noninferiority study (SUL-DUR versus colistin; non-inferiority margin 20%) in ABC hospital-acquired pneumonia, ventilator-associated bacterial pneumonia, ventilated pneumonia, or bacteremia; Part B was an open label study (SUL-DUR only) that enrolled patients with ABC infections who did not tolerate colistin/polymyxin B or whose pathogens were resistant to colistin/polymyxin B.
In 2021, Entasis announced the initiation of the Expanded Access Program (EAP.) in the US. For information on the program, requests and questions please submit these to Expandedaccess@entasistx.com.
About Entasis Therapeutics Holdings Inc.
Entasis is a late-stage clinical 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 SUL-DUR (targeting Acinetobacter baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae infections), ETX0282CPDP (targeting Enterobacterales infections) and ETX0462 (targeting Gram-negative infections including Pseudomonas). 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 “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative or plural of those terms, and similar expressions are intended to identify forward-looking statements. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements 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, rejection of our regulatory submissions, 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.
|Company Contact||Investor Contact|
|Kyle Dow||Bruce Mackle|
|Entasis Therapeutics||LifeSci Advisors|
|(781) 810-0114||(929) 469-3859|
|(215) 315 3143|