TABLE 4.
VT-1161 efficacy in murine vaginal candidiasis using clinical isolates of C. albicans with reduced susceptibility to fluconazole
| Treatment | Posttreatment CFUa |
Plasma compound level (μg/ml)b | |
|---|---|---|---|
| Day 1 | Day 4 | ||
| AR466-06 first study | |||
| Vehicle | 1,300 (868–3,758) | 825 (15–4,413) | |
| FLUc (25 mg/kg) | 1,000 (583–1,488); 0.3042 | 1,100 (525–2,813); 0.5659 | 0.082 (0.020) |
| VT-1161 (25 mg/kg) | 142 (38–298); 0.0019 | 52 (0–136); 0.0610 | 16 (5) |
| P(FLU)d | 0.0064 | <0.0001 | |
| AR466-06 second study | |||
| Vehicle | 3,342 (1,563–14,250) | 290 (73–1,475) | |
| FLU (25 mg/kg) | 1,775 (1,198–6,142); 0.4040 | 1,075 (450–2,388); 0.1594 | 0.11 (0.05) |
| VT-1161 (25 mg/kg) | 450 (66–1,788); 0.0089 | 65 (8–130); 0.0713 | 14 (4) |
| P(FLU) | 0.0431 | 0.0003 | |
| JJ330-05 | |||
| Vehicle | 47,916 (35,250–166,250) | 11,250 (4,288–26,500) | |
| FLU (25 mg/kg) | 1,875 (950–4,500); <0.0001 | 10,300 (5,817–40,458); 0.8111 | 0.039 (0.024) |
| VT-1161 (25 mg/kg) | 4,583 (863–10,625); 0.0003 | 52 (164–2,400); 0.0005 | 16 (3) |
| P(FLU) | 0.2395 | 0.0021 | |
| LP1158-07 | |||
| Vehicle | 19,250 (9,300–213,500) | 4,500 (1,850–8,033) | |
| FLU (25 mg/kg) | 12,000 (4,375–28,667); 0.2727 | 7,000 (3,250–19,500); 0.1889 | 0.061 (0.032) |
| VT-1161 (25 mg/kg) | 7,000 (3,500–13,000); 0.0854 | 18,000 (11,625–39,167); 0.0011 (inferior) | 14 (4) |
| P(FLU) | 0.3050 | 0.0647 | |
a
Data are median (interquartile range) CFU/100 μl lavage fluid at 1 day or 4 days posttreatment; P value compared to that for vehicle.
b
Data are mean (SD) levels 4 days posttreatment.
c
FLU, fluconazole.
d
P(FLU), P value compared to that for FLU. P values were determined using the Mann-Whitney U test. Bold values indicate significance.