Entasis Therapeutics Holdings Inc
Entasis Therapeutics — Technical Presentation (October 2021)
14 slides from Entasis Therapeutics's technical presentation, Oct 19, 2021
Slide 1: Phase 3 ATTACK Topline Results for Sulbactam-Durlobactam
0 Phase 3 ATTACK Topline Results for Sulbactam - Durlobactam Nasdaq: ETTX October 2021
Slide 2: Disclaimer
1 Disclaimer This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . Words such as ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘
Slide 3: Primary Efficacy and Safety Objectives of ATTACK Were Achieved
2 Primary Efficacy and Safety Objectives of ATTACK Were Achieved • Non - inferiority in 28 - day all - cause mortality vs. colistin in patients with carbapenem - resistant Acinetobacter baumannii - calcoaceticus infections and overall trend favoring SUL - DUR • Statistically significant higher clini
Slide 4: ATTACK: Single Global Phase 3 Pivotal Trial – Part A
3 ATTACK: Single Global Phase 3 Pivotal Trial – Part A Head - to - head vs. colistin in carbapenem - resistant Acinetobacter infections HABP: Hospital - acquired bacterial pneumonia; VABP: Ventilator - associated bacterial pneumonia; VP: Ventilated pneumonia. BSI: Blo odstream infection; SUL - DUR:
Slide 5: ATTACK: Single Global Phase 3 Pivotal Trial – Part B
4 ATTACK: Single Global Phase 3 Pivotal Trial – Part B 1. Includes patients with HABP, VABP and bacteremia due to colistin - resistant Acinetobacter or patients with known intolerance to colistin. Endpoints Efficacy: • 28 - Day ACM in ITT population • 14 - Day ACM in m - MITT population Safety: • Ov
Slide 6: Key Baseline Demographics Comparable Across Treatment Groups
5 Key Baseline Demographics Comparable Across Treatment Groups PART A SUL - DUR + IMI n = 64 PART A Colistin + IMI n = 64 PART B SUL - DUR + IMI n = 28 Age – Mean (Years) 61.6 65.1 56.2 Age Group (%) <65 years 65 – 75 years >75 years 56.3 25.0 18.8 48.4 18.8 32.8 67.9 17.9 14.3 Gender (% Male) 71.9
Slide 7: Achieved Primary Efficacy Endpoint non-inferiority on 28-day all-cause mortality vs. colistin
6 Achieved Primary Efficacy Endpoint SUL - DUR non - inferiority on 28 - day all - cause mortality vs. colistin CI: Confidence Interval. 32.3% 19.0% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% Colistin + IMI SUL-DUR + IMI 13.2% treatment difference; 95% CI: - 30.0, 3.5 28 - Day All - Cause Mortali
Slide 8: Secondary Endpoints: All-Cause Mortality Analyses Favor SUL-DUR
7 Secondary Endpoints Primary Endpoint (11.7%) (12.8%) (11.8%) (13.2%) (13.2%) -40% -30% -20% -10% 0% 10% 20% 30% 14 Day ACM m-MITT (N = 154) 14 Day ACM CRABC m-MITT (N = 127) 28 Day ACM ITT (N = 175) 28 Day ACM m-MITT (N = 152) 28 Day ACM CRABC m-MITT (N = 125) All - Cause Mortality Analyses Favor
Slide 9: Statistically Significant Difference in Clinical Cure at Test of Cure
8 Statistically Significant Difference in Clinical Cure SUL - DUR compared to colistin at Test of Cure Clinical Cure at Test of Cure (%) 40.3% 61.9% 0.0% 20.0% 40.0% 60.0% 80.0% Colistin + IMI SUL-DUR + IMI 21.6% treatment difference; 95% CI: 2.9, 40.3
Slide 10: Clinical Cure Rates Favor SUL-DUR at All Measured Timepoints
9 Clinical Cure Rates Favor SUL - DUR at All Measured Timepoints Statistically significant difference in clinical cure at End of Treatment and Test of Cure 12.2% 21.6% 29.4% -40% -30% -20% -10% 0% 10% 20% 30% 40% 50% Late Follow Up Test of Cure End of Treatment Clinical Cure Rate Treatment Differenc
Slide 11: All-Cause Mortality Rate in Part B Consistent with Part A
10 All - Cause Mortality Rate in Part B Consistent with Part A Low all - cause mortality in Part B 19.0% 17.9% 6.3% 10.7% 0.0% 5.0% 10.0% 15.0% 20.0% Part A Part B Part A Part B 28-Day All-Cause Mortality 28-Day All-Cause Mortality 14-Day All-Cause Mortality 14-Day All-Cause Mortality All - Cause Mo
Slide 12: Comparable Adverse Events Between Treatment Groups
11 Comparable Adverse Events Between Treatment Groups SUL - DUR compared to colistin PART A SUL - DUR + IMI (N=91) PART A Colistin + IMI (N=86) PART B SUL - DUR + IMI (N=28) Any Adverse Event (AE) (%) 87.9 94.2 89.3 Drug - Related TEAEs (%) 12.1 30.2 10.7 Serious AEs (%) 39.6 48.8 32.1 Drug - Relate
Slide 13: Statistically Significant Reduction in Nephrotoxicity vs. colistin
12 Statistically Significant Reduction in Nephrotoxicity SUL - DUR vs. colistin as measured by the RIFLE classification RIFLE: Risk, Injury, and Failure; and Loss; and End - stage kidney disease (measured by creatinine level or glomerular filtration rate) 37.6% 13.2% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0
Slide 14: A Significant Milestone for Patients, a Pivotal Moment for Entasis
13 A Significant Milestone for Patients, a Pivotal Moment for Entasis • SUL - DUR first to achieve statistical non - inferiority in 28 - day all - cause mortality in patients with CRAB • Statistically significant difference in clinical cure at Test of Cure • Favorable safety profile with statistical
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