Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 198

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 198
---
 100 mg 
   (N=36) |     | Placebo 
 (N=108) |
| Galactorrhea                       |     | 2 (1.9%) |     | 1 (0.9%) |     |        0 |     |       0 |
| Breast enlargement                 |     |        0 |     |        0 |     | 1 (2.8%) |     |       0 |
| Erectile dysfunction               |     |        0 |     |        0 |     | 1 (2.8%) |     |       0 |
| Total related to Protactin         |     | 2 (1.9%) |     | 1 (0.9%) |     | 2 (5.6%) |     |       0 |

Sedation

| Number of subjects (% of treatment 
 group)                             |     |         |     |          |     |        |     |         |
| Preferred Term                     |     |   50 mg 
 (N=107) |     | 75 mg    
 (N=108)  |     | 100 mg 
 (N=36) |     | Placebo 
 (N=108) |
| Sedation                           |     |       0 |     | 1 (0.9%) |     |      0 |     |       0 |

QTcF Prolongation

| QTcF from Baseline at Day 28 
 (ms)                         |     |         |     |         |     |        |     |         |
|                              |     |   50 mg 
 (N=107) |     |   75 mg 
 (N=108) |     | 100 mg 
 (N=36) |     | Placebo 
 (N=108) |
| Baseline                     |     |   393.4 |     |   394.7 |     |    390 |     |   393.4 |
| Day 28                       |     |     4.9 |     |     4.3 |     |    5.4 |     |     1.7 |

Stopping criteria not met at any dose

Exploratory Endpoints We also included a measure of cognition as an exploratory endpoint in our Phase 2 trial. This analysis utilized the CogState Computerized Schizophrenia Battery of Tests, a well validated measure of cognitive ability