BAXDELA (delafloxacin) | Microbiological Activity in ABSSSI

BAXDELA™ Microbiological Eradication Rates

Microbiologic Response^a 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

MRSA

Baseline MIC (µg/mL)	Eradicated^a 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)

MSSA

Baseline MIC (µg/mL)	Eradicated^a 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

K pneumoniae

Baseline MIC (µg/mL)	Eradicated^a 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)

E coli

Baseline MIC (µg/mL)	Eradicated^a 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)

P aeruginosa

Baseline MIC (µg/mL)	Eradicated^a 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)

E cloacae

Baseline MIC (µg/mL)	Eradicated^a 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.

Microbiological Activity