Innovative Therapeutics in Oncology and Neuroscience
.
SUL-DUR
A Novel Therapeutic Option with Statistically Higher Clinical
Cure Rate and Favorable Safety Profile
Current Treatment Options Have
Poor Efficacy and Tolerability
Emergence of pan-drug-resistant Acinetobacter
• Combination antibiotic therapy not proven effective
• Colistin or tigecycline most commonly used for
Acinetobacter baumannii-calcoaceticus complex
(ABC) in China
VS.
Tigecycline
Colistin
Clinical
Efficacy
Poor efficacy in
pneumonia¹
Poor efficacy in
pneumonia,
black box warning²
•
Safety/
Tolerability
Nephrotoxicity
Gl intolerance
XACDURO®
(sulbactam for injection;
durlobactam for injection),
co-packaged for intravenous use
Approved
(U.S.)
First FDA approved
pathogen-targeted
therapy to treat hospital-
acquired and ventilator-
associated pneumonias
caused by Acinetobacter
Phase 3 ATTACK study (vs. Colistin)
Met primary endpoint for 28-day all-cause mortality
•
19.0% (SUL-DUR) vs. 32.3% (Colistin), with treatment
difference of -13.2%3
Significant difference in clinical cure rates; clinical and
microbiological responses consistently showed benefit
• Favorable safety profile.
Potential NMPA approval for the treatment of infections caused by ABC in 2024
Source: Entasis press release, May 2023.
Notes: The trademarks and registered trademarks within are the property of their respective owners. (1) Mortality associated with colistin-based therapy is -40% (95% CI: 32% to 47%); (2) Warning in US Product Label-lower cure rates and higher
mortality in ventilator-associated pneumonia; (3) Kaye KS, et al. Efficacy and safety of sulbactam-durlobactam versus colistin for the treatment of patients with serious infections caused by Acinetobacter baumannii-calcoaceticus complex: a multicentre,
44 randomised, active-controlled, phase 3, non-inferiority clinical trial (ATTACK). Lancet Infect Dis. 2023 May 11:S1473-3099(23)00184-6.
Clinical Data -
Anti-infectiveView entire presentation