Table 1.
Baseline characteristics (mITT set)
| Ibrexafungerp (N = 239) | Placebo (N = 121) | |
|---|---|---|
| Age (years) | ||
| Mean (SD) | 32.4 (7.72) | 33.5 (8.54) |
| Median | 32.0 | 34.0 |
| Min, max | 18, 53 | 18, 58 |
| Ethnic group, n (%) | ||
| Han Chinese | 208 (87.0) | 105 (86.8) |
| Others | 31 (13.0) | 16 (13.2) |
| BMI (kg/m2) | ||
| Mean (SD) | 21.8 (3.14) | 22.5 (3.65) |
| Median | 21.4 | 21.6 |
| Min, max | 15.8, 34.5 | 17.0, 34.2 |
| BMI category, n (%) | ||
| < 28 kg/m2 | 228 (95.4) | 110 (90.9) |
| ≥ 28 kg/m2 | 11 (4.6) | 11 (9.1) |
| Menopause, n (%) | ||
| Yes | 3 (1.3) | 7 (5.8) |
| No | 236 (98.7) | 114 (94.2) |
| Diabetes mellitus, n (%) | ||
| Yes | 7 (2.9) | 3 (2.5) |
| No | 232 (97.1) | 118 (97.5) |
| Baseline VSS score | ||
| Mean (SD) | 4.9 (2.14) | 4.6 (1.77) |
| Median | 5.0 | 5.0 |
| Min, max | 2, 15 | 2, 11 |
| Severity based on VSS Score, n (%) | ||
| Mild to moderate (< 7) | 195 (81.6) | 106 (87.6) |
| Severe (≥ 7) | 44 (18.4) | 15 (12.4) |
| Cultured Candida spp. at screening, n (%)a | ||
| C. albicans | 161 (67.4) | 75 (62.0) |
| FLU susceptible C. albicans | 113 (47.3) | 56 (46.3) |
| FLU non-susceptible C. albicansb | 48 (20.1) | 19 (15.7) |
| C. glabrata | 60 (25.1) | 38 (31.4) |
| C. krusei | 9 (3.8) | 4 (3.3) |
| Other speciesb | 9 (3.8) | 5 (4.1) |
FLU fluconazole, mITT modified intent-to-treat, SD standard deviation, BMI body mass index, VVC vulvovaginal candidiasis, VSS vulvovaginal signs and symptoms
aPatients may have more than 1 Candida species at screening and would be counted once at each species level
bFluconazole non-susceptible C. albicans included both susceptible-dose dependent strains and resistant strains per Clinical and Laboratory Standards Institute M60 guideline
cOther species included C. parapsilosis, C. tropicalis, C. metapsilosis and C. inconspicua