Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX) has reported topline data from the ATTACK study. ATTACK trial is a global third phase registration study assessing efficacy and safety of SUL-DUR relative to colistin in patients having infections resulting from Acinetobacter baumannii.
SUL-DUR attained the primary endpoint
In patients with carbapenem-resistant Acinetobacter infections, SUL-DUR met the primary endpoint of 28-day all-cause death, exhibiting statistical non-inferiority to colistin. In CRABC m-MITT and all trial populations included in the results, mortality analyses favored SUL-DUR over colistin. There was a statistically significant difference in SUL-DUR clinical response versus colistin in the Test of Cure. SUL-DUR achieved the study’s primary safety goal of a statistically significant nephrotoxicity reduction.
CEO Manos Parros said, “ATTACK was a landmark clinical trial, the first to successfully evaluate an investigational agent targeting a specific drug-resistant Gram-negative pathogen. In addition, SUL-DUR is the first investigational drug to demonstrate efficacy in a 28-day all-cause mortality trial focused on carbapenem-resistant Acinetobacter, an “Urgent” threat as designated by the CDC. We look forward to discussing our data with the regulatory agencies and preparing our first regulatory submission in mid-2022. We are grateful to our partners at Zai Lab and the investigators who made this trial possible, and to the patients and their families for their participation.”
SUL-DUR to be available in China soon
Zai Lab CEO Samantha Du said, “CRAB infections are among the worst bacterial infections, and safe and effective treatment options are limited. We look forward to bringing this drug to China, where CRAB infections are still frequently seen in ICUs and result in high morbidity and mortality.”
The study enrolled 207 patients across 17 countries at 95 clinical sites. It was a two-part study with part A randomized, comparable part in patients with Acinetobacter baumanii hospital-acquired bacterial pneumonia, ventilated pneumonia, and ventilator-associated bacterial pneumonia. Part B was an open-label study that included ABC infections resistant to colistin treatment.
