Entasis Therapeutics Holdings Inc (NASDAQ:ETTX) saw its shares move north after it announced topline results from its Phase 3 ATTACK trial of sulbactam-durlobactam (SUL-DUR) versus colistin in patients with infections caused by Acinetobacter baumannii.
Colistin (polymyxin E) is an antibiotic medication used as a last resort for multidrug-resistant Gram-negative infections.
SUL-DUR met the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and demonstrated statistical non-inferiority versus colistin.
SUL-DUR also achieved a statistically significant reduction in nephrotoxicity. SUL-DUR mortality was 19.0% (12/63) compared to 32.3% (20/62) in the colistin arm (treatment difference of -13.2%).
A statistically significant difference in clinical cure at Test of Cure (TOC) was observed with 61.9% in the SUL-DUR arm compared to 40.3% in the colistin arm.
Overall adverse events in the safety population were comparable between treatment groups.The company is targeting marketing application submission in mid-2022.
Said CEO Manos Perros, "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.
"The positive outcome of the ATTACK trial is the culmination of a tremendous effort by our team, and a major milestone for Entasis. We look forward to discussing our data with the regulatory agencies and preparing our first regulatory submission in mid-2022."
ETTX shares gained 12 cents, or 3.9%, at $3.23 at the open Tuesday.
