Entasis Therapeutics Holdings Inc. announced the presentation of additional safety and efficacy data from the Company's pivotal Phase 3 ATTACK trial. The study results will be presented at IDWeek 2022, the annual meeting of the Infectious Disease Society of America held October 19-23, 2022 in Washington, D.C. An oral presentation entitled Microbiologic and clinical outcome concordance in the global phase 3 ATTACK trial: sulbactam-durlobactam (SUL-DUR) versus colistin therapy in patients with Acinetobacter baumannii-calcoaceticus complex (ABC) infections will be presented October 201:45-3pm 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, will be presented October 201:45-3pm 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 >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, and clinical pharmacokinetic/pharmacodynamic (PK/PD) analyses for sulbactam-durlobactam (SUL-DUR) to support dose selection for the treatment of Acinetobacter baumannii calcoaceticus complex infections will be presented October 221:45-3pm 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 3 ATTACK trial. Investigators concluded that simulated plasma and ELF exposures yielded >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.

SUL-DUR is an intravenous, or IV, investigational drug that is a combination of sulbactam, an IV ß-lactam antibiotic, and durlobactam, a novel broad-spectrum IV ß-lactamase inhibitor, or BLI, being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant strains. Top-line results were announced in October 2021. Entasis Therapeutics will consider providing a requesting physician with pre-approval access to SUL-DUR, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met.

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