A profile of delafloxacin in the treatment of adults with community-acquired bacterial pneumonia

Figures & data

Table 1. In vitro susceptibility of selected pathogens to delafloxacin.

Organism (number of isolates) [ref.]	MIC50 (μg/ml)	MIC90 (μg/ml)	MIC range (μg/ml)
Gram positive
S. pneumoniae (450) [37]	0.008	0.015	≤0.004 to 0.25
S.pneumoniae penicillin resistant (>1 μg/ml) [37]	0.008	0.015	0.008 to 0.015
MSSA (777) [37]	≤0.004	0.008	≤0.004 to 4
MRSA (573) [37]	0.06	0.5	≤0.004 to 4
MS- CoNS (75) [37]	≤0.004	0.06	≤0.004 to 1
MR- CoNS (125) [37]	0.06	0.5	≤0.004 to 2
Streptococcus pyogenes (433) [37]	0.008	0.0015	≤0.004 to 0.03
Streptococcus agalactiae (225) [37]	0.008	0.015	≤0.004 to 0.5
Streptococcus dysgalactiae (132) [37]	0.008	0.015	≤0.004 to 0.03
Viridans group streptococci (294) [37]	0.015	0.03	≤0.004 to 2
E. faecalis (450) [37] All	0.06	1	≤0.004 to 2
Vancomycin-susceptible [45]	NA	1	≤0.004 to 2
Vancomycin-resistant [45]	NA	1	≤0.008 to 2
E. faecium (295) [37]	>4	>4	0.008 to >4
Vancomycin-susceptible [45]	NA	>4	0.008 to >4
Vancomycin-resistant [45]	NA	<4	>4
Gram negative
Enterales (2.250) [37]	0.06	4	≤0.004 to >4
Escherichia coli (500) [37]	0.03	4	≤0.004 to >4
E.coli isolates of the ESBL phenotype (92) [37]	2	>4	0.008 to >4
Klebsiella pneumoniae (389) [37]	0.06	>4	0.015 to >4
K.pneumoniae isolates of the ESBL phenotype (102) [37]	4	>4	0.06 to >4
Klebsiella oxytoca (111) [37]	0.06	0.12	0.03 to 1
Proteus mirabilis (211) [37]	0.06	2	0.015 to >4
Enterobacter spp. (384) [37]	0.06	1	≤0.004 to >4
Citrobacter spp. (178) [37]	0.06	2	0.008 to >4
Indole positive Proteus spp. (249) [37]	0.12	4	0.008 to >4
Serratia spp. (193) [37]	1	2	0.03 to >4
P.aeruginosa (200) [37]	0.25	>4	0.015 to >4
Acinetobacter baumannii-A.calcoaceticus (200) [40]	2	>4	0.015 to >4
Anaerobes
Clostridioides difficile (50) [46]	0.064	0.125	0.008 to 0.5
Gram-positive anaerobic cocci [43]	0.008	0.032	0.008 to 0.25
Propionibacterium acnés (32) [43]	0.125	0.125	0.032 to 0.125
Clostridium perfringens (50) [43]	0.008	0.008	0.008 to 0.032
Bacteroides fragilis (100) [43]	0.064	0.125	0.032 to 0.125
Porphyromonas and Prevotella spp. (55) [43]	0.032	0.25	0.008 to 0.5
Fusobacterium nucleatum (30) [43]	0.008	0.064	0.008 to 0.125
Respiratory pathogens
Haemophilus influenzae (200) [38]	≤ 0.001	0.004	≤ 0.001 to 0.25
Moraxella catarrhalis (100) [38]	0.008	0.008	0.004 to 0.015
Chlamydia pneumoniae (13) [39]	N/A	0.125	0.06 to 0.125
Mycoplasma pneumoniae (101) [43]	0.25	0.5	0.063 to 0.5
Legionella pneumophila (14) [39]	0.12	0.12	0.12
Miscellaneous
Neisseria gonorrhoeae (117) [44]	0.06	0.125	≤0.001 to 0.25

MIC: minimum inhibitory concentration, NA, not available.

Table 2. Pharmacokinetic and pharmacodynamic differences of delafloxacin with levofloxacin and moxifloxacin.

	Delafloxacin IV 300 mg every 12 h	Levofloxacin PO 500 mg every 24 h	Moxifloxacin PO 400 mg every 12 h
Protein Binding (%)	84	24–38	50
Urinary fraction (%)	64.5	87	20
Bioavailability (%)	58.8	99	90
Tmax (h)	1.00	6–7	1.49
Cmax (mg/L)	9.29	6.2	4.5
T1/2 (h)	3.7	6–7	12
MIC90	0.015	1	0.25
AUC0-24 (mg/h/L)	61.6	47.5	48
24-h fAUC/MIC (mg/h/L)	9.86	34	29
References	[37,52,54,56]	[44,55]	[44,55]

Tmax: time to Cmax; Cmax: peak serum concentration; T1/2: half-life; MIC₉₀: Minimum inhibitory concentration of 90% of the S.pneumoniae strains evaluated; AUC_0-24: 24-h area under plasma concentration curve over 24 h; fAUC/MIC: ratio of the area under the free drug concentration–time curve to the minimum inhibitory concentration of the infecting organism.

Table 3. Phase I delafloxacin trials: pharmacokinetics, safety and tolerability profile.

PHASE I
Phase		Study type	Sample Size (n)*	Dose and administration route	Outcomes	Main Clinical Results.	Safety and Tolerability
I	Mc Ewan 2015 [57]	Open-label, mass balance phase I trial	6	300 mg IV (single dose)	-Determine the rates and routes of excretion. -Investigate the PK profile. -Identify the major circulating drug-related components.	-Elimination: predominant renal excretion. Biliary/intestinal less relevant - 70% circulation and excretion unchanged - Main metabolite: delafloxacin glucuronide	AEs non mentioned
I	Litwin 2015 [62]	A Randomized, double-blind, placebo-controlled, 4-period crossover study	52	300 mg IV DLX 900 mg IV DLX 450 mg PO moxifloxacin	-Evaluate effect of DLX in cardiac repolarization	Not evaluated	No prolongation of QTc were observed in DLX arms.
I	Hoover 2016 [52]	Double-blind, randomized, single-ascending-dose trial	62	300 mg IV (single dose) 450 mg IV (single dose) 600 mg IV (single dose) 750 mg IV (single dose) 900 mg IV (single dose) 1200 mg IV (single dose)	-Determine the PK, safety and tolerability of a single dose IV DLX.	-Mean terminal half-life 12 hours - Cmax and AUC values increased with the increasing of the IV dose.	Gastrointestinal disorders most common AE (32%): mild intensity and dose-related events.
		Double-blind, randomized, placebo-controlled study	12	300 mg IV bid 14 days	-Evaluate the PK, safety and tolerability of multiple IV DLX doses	- No accumulation of DLX after 14 days.	Well tolerated after multiple doses
		Open-label, randomized, 2-period, 2-sequence crossover study	56	450 mg PO 300 mg IV	Compare PK, safety and tolerability of oral and IV delafloxacin	-No relevant differences in PK profile between oral and IV administration.	Well tolerated (AEs in 20%: mainly headache and diarrhea. Mild intensity)
I	Hoover 2016 [53]	Randomized, double-blind, placebo-controlled, single ascending-dose study	56	50 mg PO (single dose) 100 mg PO (single dose) 200 mg PO (single dose) 400 mg PO (single dose) 800 mg PO (single dose) 1200 mg PO (single dose) 1600 mg PO (single dose) (Unformulated drug)	-Determine PK parameters, safety and tolerability profile of a single ascending oral dose of DLX	- Cmax and AUC increased with increasing oral dose. - Peak concentration about 1 h after oral administration - Half-life 6–8 h	Gastrointestinal AEs the most common -More frequent with higher doses -Mild or moderate intensity -No evidence of QTc interval prolongation nor alteration in laboratory findings. -Food, sex and age did not significantly affect the safety profile. - Well tolerated after multiple doses.
		Randomized, double-blind, single dose, 2-period crossover study	20	250 mg PO (single dose (Unformulated drug)	Food-effect study with unformulated drug in a gelatin capsule	Reduction of Cmax and AUC with high-fat meal compared with fasting conditions.
		Randomized, double-blind, single dose, parallel-group, placebo-control study	32	(Unformulated drug)	-Evaluate PK, safety and tolerability in women and healthy elderly people	- Sex: No PK differences between sex - Age: AUC was higher in elderly subjects (attributed to a lower creatinine clearance).
		Randomized, double-blind, placebo-controlled, multiple ascending-dose study	60	100 mg PO od 5 days 200 mg PO od 5 days 400 mg PO od 5 days 800 mg PO od 5 days 1200 mg PO od 5 days (Unformulated drug)	Evaluate PK, safety and tolerability profile after multiple oral dose of DLX	Half-life longer after multiple doses compared with single administration.
		Single-dose randomized, open-label, 3-period,6-sequence cross- over study	30	900 mg (450 mg PO BID) (Tablet formulation)	Food-effect study with formulated tablets	The Cmax of DLX was decreased only slightly in the presence of food, but AUC was not significantly affected.
I	Hoover 2016 [59]	Open-label study (healthy subjects and liver disease patients stratified according to Child-Pugh score)	36	300 mg IV (single dose)	-Evaluate the PK and safety of DLX in hepatic impairment subjects (including Child-Pugh A, B and C).	-No differences in DLX exposure and clearance comparing with healthy subjects). -No need of initial dose adjustment in hepatic impairment subjects.	Well tolerated (mild-moderate AEs).
I	Hoover, 2018 [60]	open-label, parallel-group crossover trial (healthy subjects and renal impairment subjects)	34	300 mg IV 400 mg PO	-Evaluate the PK and safety in renal impairment subjects	-DLX clearance decreased as renal function worsened (AUC about 2-fod higher than normal renal group if GFR < 30 mL/min) -Dose adjustment recommendable if GFR < 30 mL/min	Well tolerated (gastrointestinal events most common AE, 17.6%)
I	Hoover 2018, [61]	open-label, parallel-group, crossover trial (ESRD subjects and healthy subjects)	19	300 mg IV (single dose)	Evaluate the PK and safety of in hemodialysis subjects.	- Although dialyzable, a significant DLX accumulation was observed in patients with ESRD (AUC about 2-fod higher in ESRD group than healthy subjects).	Well tolerated (GI AEs most common reported: 50% in ESRD)
I	Dave 2018 [63]	Randomized, investigator-blind, placebo/active-controlled, parallel-group study	52	DLX 200 mg PO QD 6 days DLX 400 mg PO QD 6 days LMX 400 mg PO QD 6 days	Evaluate the potential phototoxicity of DLX	Not evaluated	Not clinically significant phototoxic potential demonstrated.

*Phase I trials were conducted in healthy participants. In Phase I trials conducted to evaluate delafloxacin in hepatic and renal impairment subjects [63–65], participants were otherwise healthy. Abbreviations: DLX, delafloxacin; LMX, lomefloxacin; IV, intravenous; PO, oral administration; bid, twice a day; PK, pharmacokinetic; AUC, area under curve, AE, adverse event; ESRD, end-stage renal disease.

Table 4. Summary table of Phase II and III delafloxacin trials: efficacy.

PHASE II STUDIES
Indication	Study type	Population (sample size)	Primary Outcome	Delafloxacin (dose, route)	Comparator (dose, route)	Duration of treatment	Main results	Safety
SSSI	O’Riordan 2015: Phase II, randomized (1:1:1), double-blind multicenter trial in SSSI [67]	150	Clinical cure at TOC visit (14–21 days)	DLX 300 mg IV BID DLX 450 mg IV BID	Tigecycline (100 mg IV one dose, followed 50 mg IV BID)	5–14 days	Similar result in primary outcome: Clinical cure rates at TOC visit: DLX 300 mg 94.3% (33/35), DLX 450 mg 92.5% (n = 37/40), TIG 91.2% (n = 31/34)	300 mg DLX group was the best-tolerated regimen
	Kingsley 2016: Phase II, randomized (1:1:1), double-blind, multicenter trial in SSSI [68]	256	Clinical cure at follow-up visit	DLX 300 mg IV BID	-Linezolid 600 mg IV BID -Vancomycin 15 mg/kg IV BID	5–14 days	- Similar result in primary outcome between DLX and LZD, and better results than VAN: Clinical cure at follow-up visit: DLX 300 mg 70.4% (57/81), LZD 64.9% (50/77), VAN 54.1% (53/98) - Better clinical cure with DLX than VAN in obese population. -No differences in bacterial eradication	Well tolerated (Gastrointestinal events most common AEs)
Lower Respiratory Tract Infections	Longcor 2012: Phase II, randomized (1:1:1:1), double-blind study in patients with acute bacterial exacerbation of COPD [64]	280	Clinical cure and bacteriological eradication	DLX 100 mg PO QD DLX 200 mg PO QD DLX 400 mg PO QD	LVX 500 mg PO QD	7 days	-Clinical cure was similar in the four groups: DLX 100 mg 72% (49/68), 200 mg 69% (47/68). 400 mg 79% (54/68) and LVX 75% (52/69) - Microbiological eradication: a significant dose-response trend was observed with DLX groups: DLX 100 mg 81% (21/26), 200 mg 96% (24/25), 400 mg 97% (32/33), LVX 94% (33/35)	Most common AE: diarrhea, nausea and headache (diarrhea was dose-related event)
	Longcor 2012: Phase II, randomized (1:1:1), double-blind study in patients with community-acquired bacterial pneumonia (CABP) [66]	309	Clinical cure and bacteriological eradication	DLX 100 mg PO DLX 200 mg PO DLX 400 mg PO	–	7 days	-Clinical cure: DLX 100 mg 80% (83/104), 200 mg 87% (79/91) and 400 mg 87% (90/104) -Microbiological eradication: DLX 100 mg 88% (53/60), 96% (48/50), 96% (48/50)	Incidence of drug-related AEs: 23%, 37%, and 28% in the 100, 200, and 400 mg groups (mainly diarrhea, nausea and headache)
PHASE III STUDIES
Indication	Study type	Population (sample size)	Primary Outcome	Delafloxacin (dose, route)	Comparator (dose, route)	Duration of treatment	Main results	Safety
SSSI	Pullman 2017: A Phase 3, randomized, stratified, double-blind, multicenter trial in SSSI. [72]	660	Objective response at 48–72 h	DLX 300 mg IV BID	VAN 15 mg/kg IV BID + AZT 1 g IV BID	5–14 days	Non inferiority of DLX for the primary outcome: DLX and VAN-AZT 78.2% (259/331) and 80.9% (266/329)	Delafloxacin presented a lower overall discontinuation rate compared with vancomycin/aztreonam.
	O’Riordan 2018: Phase III, randomized (1:1) double-blind, multicenter trial in SSSI [73]	850	Clinical response 48–72 h	DLX 300 mg IV BID DLX 450 mg IV BID	VAN 15 mg/kg IV BID + AZT 1 g IV BID	5–14 days	Non inferiority of DLX: Objective response 48–72 h: DLX 83.7% (354/423)and VAN-AZT 80.6% (344/427)	Similar incidence of drug-related AEs in both groups (20.9%)
CABP	Horcajada 2019: Phase III, randomized, double-blind, comparator-controlled, multicenter study in CABP [69]	860	Early clinical response	DLX 300 mg BID IV DLX 450 mg BID PO	MVX 450 mg QD IV/PO	5–10 days	Non-inferiority of DLX compared with MVX was demonstrated. Early clinical response rates: DLX 88.9% (383/431), MVX 89.0% (381/428).	Incidence of drug-related AEs: DLX 15.6%, MVX 12.6%.
Uncomplicated urogenital Ghonorrhea	Hook E. 2019: Phase III, randomized (2:1), open-label, single-dose, multicenter study in uncomplicated urogenital ghonorrhea [74]	460	Urogenital microbiological cure in the urogenital samples	DLX 900 mg PO	CFX 250 mg IM	Single-dose	A single 900 mg dose of DLX did not demonstrated non-inferiority whencompared with IM CFX Urogenital microbiological cure rates: DLX 85.1% (194/228) and CFX 91.0% (91/100)	Most common AEs were gastrointestinal events (mainly diarrhea).

Abbreviations: SSSI, skin and skin structure infections; COPD, chronic obstructive pulmonary disease; CABP, Community-acquired bacterial pneumonia; DLX, delafloxacin; TIG, tigecycline; LZD, linezolid; VAN, vancomycin; AZT, aztreonam; LVX, levofloxacin; MVX, moxifloxacin; CFX, ceftriaxone; IV, intravenous; PO, oral administration; IM, intramuscular; QD, once a day; BID, twice a day; TOC, test of cure.

Table 5. Safety of delafloxacin in Phase III clinical trials: Overall global data of phase III published trials.

Drug-related adverse events	Delafloxacin (N = 1474)	Comparator group (N = 1332)
Gastrointestinal disorders
Diarrhea	158 (10.7%)	24 (1.8%)
Nausea and vomits	80 (5.4%)	7 (0.5%)
Flatulence	7 (0.5%)	0 (0%)
CNS disorders
Headache	17 (1.2%)	17 (1.3%)
Dizziness	7 (0.5%)	1 (0%)
Convulsions	0 (0%)	1 (0%)
Tendon disorders	3 (0.2%)	0 (0%)
Myopathy	7 (0.5%)	25 (1.9%)
Peripheral neuropathy	1 (0%)	2 (0.15%)
Skin disorders	8 (0.5%)	35 (2.6%)
Hyperglicemia	2 (0.1%)	3 (0.2%)
Hypoglicemia	1 (0%)	2 (0.15%)
C. difficile	3 (0.2%)	1 (0%)
QT prolongation	0 (0%)	3 (0.2%)
Transaminases increased	27 (1.83%)	12 (0.9%)
Potential phototoxicity	0 (0%)	0 (0%)

*Delafloxacin arm included: 429 patients with community-acquired bacterial pneumonia (CABP) receiving IV/OR delafloxacin (300 mg BID IV /450 mg BID PO); 304 patients with uncomplicated urogenital gonorrhea treated with a single oral-dose of 900 mg delafloxacin; 741 patients with Skin and Skin Structure Infections (SSSI) treated with delafloxacin 300 mg IV/450 mg oral BID. **Comparator arm included: 427 patients with CABP receiving IV/OR moxifloxacin (400 mg once day); 154 patients with uncomplicated urogenital gonorrhea treated with a single dose of IM ceftriaxone (250 mg); 751 patients with SSSI treated with vancomycin (15 mg/kg) IV and aztreonam 1–2 g IV BID)

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