Microbiological Activity

BAXDELA™ Microbiological Eradication Rates

Microbiologic Responsea at Follow-up Visit (Day 14 +/− 1) Pooled data from phase 3 trials

BAXDELA achieved high eradication rates against susceptible gram-positive pathogens as well as fluoroquinolone-nonsusceptible* strains

Baseline MIC
(µg/mL)
Eradicateda
N=106
0.004 100% (3/3)
0.008 96.7% (29/30)
0.015 100% (3/3)
0.06 100% (1/1)
0.12 100% (32/32)
0.25 97.2% (35/36)
0.5 100% (2/2)
4 100% (1/1)
*Including levofloxacin-nonsusceptible MRSA; delafloxacin MIC range 0.12-4 µg/mL; 70/71 documented or presumed eradicated (one presumed persisted with an MIC of 0.25 µg/mL)
Baseline MIC
(µg/mL)
Eradicateda
N=140
0.002 100% (15/15)
0.004 100% (41/41)
0.008 97.2% (70/72)
0.015 100% (4/4)
0.03 100% (3/3)
0.12 100% (6/6)
0.5 100% (1/1)
*Including levofloxacin-nonsusceptible MSSA; delafloxacin MIC range 0.03-0.5 µg/mL; 10/10 documented or presumed eradicated

aDocumented presumed or eradicated, microbiologically evaluable population.
Data on file. Melinta Therapeutics, 2016.

BAXDELA achieved high eradication rates against susceptible gram-negative pathogens

Baseline MIC
(µg/mL)
Eradicateda
N=17
0.03 100% (3/3)
0.06 100% (2/2)
0.12 100% (8/8)
0.25 100% (3/3)
4 100% (1/1)
Baseline MIC
(µg/mL)
Eradicateda
N=11
0.008 100% (1/1)
0.015 100% (1/1)
0.03 100% (5/5)
0.06 100% (2/2)
1 100% (1/1)
2 100% (1/1)
Baseline MIC
(µg/mL)
Eradicateda
N=11
0.012 100% (2/2)
0.25 100% (4/4)
0.5 100% (2/2)
1 100% (1/1)
4 100% (2/2)
Baseline MIC
(µg/mL)
Eradicateda
N=11
0.03 100% (1/1)
0.06 100% (4/4)
0.12 100% (5/5)
2 0% (0/1)
4 100% (2/2)
Note: One E cloacae isolate persisted (MIC of 2 μg/mL).

MIC = minimum inhibitory concentration.
aDocumented presumed or eradicated, microbiologically evaluable population.
Data on file. Melinta Therapeutics, 2016.