Entasis presented follow-up data for its therapy, sulbactam-durlobactam (SUL-DUR), and its phase 3 ATTACK trial. The company is looking at a potential mid-2023 regulatory approval.
During the recent ID Week, Entasis Therapeutics, a late-stage clinical biopharmaceutical company and a subsidiary of Innoviva, had 6 abstracts selected for presentation, including 3 oral presentations involving its investigational therapy, sulbactam-durlobactam (SUL-DUR).
This antibiotic is an intravenous investigational therapy that is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a novel broad-spectrum IV β-lactamase inhibitor, targeting Acinetobacter baumannii infections.
Entasis conducted its global, randomized, active-controlled phase 3 (ATTACK) trial. The company previously reported data looking at the the safety and efficacy of SUL-DUR and colistin, in combination with imipenem/cilastatin, in patients with ABC infections.
For the ATTACK trial, the primary efficacy endpoint was a 28-day all-cause mortality in the carbapenem resistant Acinetobacter baumannii-calcoaceticus (CRABC) m-MITT cohort. All-cause mortality in the cohort (n=125) was 19.0% for SUL-DUR and 32.3% for colistin. Clinical cure rates were 61.9% for SUL-DUR and 40.3% for colistin.
During ID Week, Entasis Chief Medical Officer David Altarac, MD, MPA, presented the oral abstract, “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,” which provided some updated data points.
“At this week’s conference we presented data that substantiates the efficacy endpoint, which was the 28-day all-cause mortality,” Altarac said in an interview with Contagion at ID Week.
The company also looked further for other additional endpoints and Altarac said they saw “concordance” in all-cause mortality, clinical and microbiologic outcomes, and noted that is not always seen in these trials.
They also evaluated the investigational therapy across geographics and resistance patterns and saw the same results. “What the data showed was there was a significant difference in the all-cause mortality when you compared patients who received sulbactam-durlobactam vs. the comparator in the study, which was colistin,” Altarac said.
During the interview, Altarac provided more insights about the data as well as the company’s timeline for potential regulatory approval within the United States.