Shares of USA-based antibacterial products developer Entasis Therapeutics (Nasdaq: ETTX) were up 27% at $3.95 pre-market, as the company announced positive top-line results from its ATTACK trial - a global Phase III registrational trial evaluating the safety and efficacy of sulbactam-durlobactam (SUL-DUR) versus colistin in patients with infections caused by Acinetobacter baumannii.
SUL-DUR met the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections (CRABC m-MITT* population in Part A of the study), demonstrating statistical non-inferiority versus colistin. Mortality analyses favored SUL-DUR versus colistin in CRABC m-MITT and all study populations included in the top-line results. At Test of Cure, there was a statistically significant difference in clinical response favoring SUL-DUR over colistin. SUL-DUR met the primary safety objective of the study achieving statistically significant reduction in nephrotoxicity.
“ATTACK was a landmark clinical trial, the first to successfully evaluate an investigational agent targeting a specific drug-resistant Gram-negative pathogen. 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,” said Manos Perros, chief executive at Entasis.
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