From: Latozinemab, a novel progranulin-elevating therapy for frontotemporal dementia
 | Double-blind, SAD HVs | Open-label | |||||||
---|---|---|---|---|---|---|---|---|---|
 |  | Latozinemab dose level |  |  | aFTD-GRN 60 mg/kg (N = 6) | ||||
 | Pooled placebo (n = 12) | 2 mg/kg (n = 7) | 6 mg/kg (n = 6) | 15 mg/kg (n = 6) | 30 mg/kg (n = 6) | 60 mg/kg (n = 13) | Total AL001 (n = 38) | Total (N = 50) | |
Any TEAE, n (%) [E] | 8 (66.7) | 2 (28.6) | 5 (83.3) | 4 (66.7) | 5 (83.3) | 8 (61.5) | 24 (63.2) | 32 (64.0) [70] | 4 (66.7) |
Any treatment-related TEAE, n (%) [E] | 1 (8.3)a | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7)a | 0 (0.0) | 1 (2.6) | 2 (4.0) | 1 (16.7)b |
Severity of TEAEs, n (%) [E] | |||||||||
Mild | 0 (0.0) | 0 (0.0) | 2 (33.3) | 1 (16.7) | 0 (0.0) | 3 (23.1) | 6 (15.8) | 6 (12.0) | 4 (66.7) |
Moderate | 7 (58.3) | 2 (28.6) | 3 (50.0) | 3 (50.0) | 5 (83.3) | 4 (30.8) | 17 (44.7) | 24 (48.0) | 0 (0.0) |
Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Life-threatening | 1 (8.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (7.7) | 1 (2.6) | 2 (4.0) | 0 (0.0) |
Death | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Severity of treatment-related TEAEs, n (%) [E] | |||||||||
 Mild | 1 (8.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (2.6) | 2 (4.0) | 1 (16.7) |
 Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
 Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
 Life-threatening | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
 Death | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
 Any SAE, n (%) [E] | 1 (8.3)c | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (7.7)c | 1 (2.6) | 2 (4.0) | 0 (0.0) |
 Any treatment-related SAE, n (%) [E] | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
 Any TEAE leading to discontinuation, n (%) [E] | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
 Any DLAE, n (%) [E] | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |