Data from landmark phase III ATTACK trial presented at IDWEEK 2022 for sulbactam-durlobactam v. colistin therapy in Acinetobacter baumannii-calcoaceticus complex infections
Entasis Therapeutics Holdings Inc., a wholly owned subsidiary of Innoviva, Inc announced the presentation of additional safety and efficacy data from the Company’s pivotal Phase III ATTACK trial. The study results were presented at IDWeek 2022, the annual meeting of the Infectious Disease Society of America held October 19-23, 2022 in Washington, D.C.
Oral Presentations: An oral presentation entitled "Microbiologic and clinical outcome concordance in the global phase III ATTACK trial: sulbactam-durlobactam (SUL-DUR) versus colistin therapy in patients with Acinetobacter baumannii-calcoaceticus complex (ABC) infections", were presented October 20 1:45-3pm ET by David Altarac, MD Chief Medical Officer of Entasis. Results of the study showed non-inferiority in 28-day all-cause mortality and overall trends favoring SUL-DUR, such as higher clinical cure rate at Test of Cure and greater microbiologic favorable response at Test of Cure. The study showed that treatment with SUL-DUR demonstrated lower mortality, higher clinical cure rates, and greater microbiologically favorable outcomes than colistin in patients with carbapenem-resistant ABC infections. Concordance between clinical and microbiological outcomes was observed.
The second oral presentation entitled "Efficacy of sulbactam-durlobactam (SUL-DUR) versus colistin in patients with extensively drug-resistant (XDR) and pan-drug resistant (PDR) Acinetobacter baumannii-calcoaceticus complex (ABC) infections", were presented October 20 1:45-3pm ET by Alita Miller, PhD, interim Chief Scientific Officer for Entasis. Results showed that ABC isolates from patients in ATTACK were highly antibiotic-resistant, but greater than 95% susceptible to SUL-DUR. Treatment with SUL-DUR demonstrated lower mortality, higher clinical cure rates, and greater microbiologically favorable outcomes than colistin in patients with XDR or PDR ABC infections. In global surveillance studies, 100% of PDR ABC isolates were susceptible to SUL-DUR.
The third oral presentation titled "Population pharmacokinetic (PPK), pharmacokinetic/pharmacodynamic attainment (PTA), and clinical pharmacokinetic/pharmacodynamic (PK/PD) analyses for sulbactam-durlobactam (SUL-DUR) to support dose selection for the treatment of Acinetobacter baumannii calcoaceticus complex (ABC) infections" were presented October 22 1:45-3pm ET in the late breaking session by Sujata Bhavnani, PharmD, M.S., FIDSA of the Institute for Clinical Pharmacodynamics. This study evaluated PPK in 373 subjects, including 110 patients who received SUL-DUR and underwent PK sampling in the pivotal Phase III ATTACK trial. Investigators concluded that simulated plasma and ELF exposures yielded greater than 90% probability of target attainment, which when combined with the favorable efficacy and safety findings from ATTACK, support a dose of 1.0 g sulbactam/1.0 g durlobactam via a 3-hour infusion, every 6 hours in patients with normal renal function and renal function-based dose adjustments.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins