Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 209

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 209
---
.9%) |
| Somnolence                             |     | 1 (0.9%)   |     | 4 (3.7%)   |     | 2 (5.6%)   |     |               0 |
| Constipation                           |     | 4 (3.7%)   |     | 1 (0.9%)   |     | 2 (5.6%)   |     |               0 |

TEAEs reported in 5% or more of patients in any cohort. Ten participants reported TEAEs leading to withdrawal, including two in each of the placebo and 50 mg cohorts as well as three in each of the 75 mg and 100 mg cohorts. There were five reported serious adverse events, or SAEs, overall with two SAEs in the placebo cohort (psychotic disorder and death), one SAE in the 50 mg cohort (suicidal ideation – deemed possibly related to treatment), one SAE in the 75 mg cohort (dystonia – deemed possibly related to treatment) and one SAE in the 100 mg cohort (psychotic disorder – deemed not related to treatment). The incidence of TEAEs was similar across groups, with most events being mild or moderate. 146

Because of the frequency of certain adverse events associated with schizophrenia medications, we identified adverse events of special interest, including EPS, sedation, adverse events associated with a prolactin increase, and QT interval corrected for heart rate, or QTcF, prolongation. These adverse events are depicted in the tables below.

EPS

| Number of subjects (% of treatment 
 group)                             |     |          |     |          |     |          |     |          |
| Preferred Term                     |     |    50 mg 
  (N=107) |     | 75 mg    
 (N=108)  |     |   100 mg 
   (N=36) |     | Placebo  
 (N=108)  |
| Dystonia                           |     |        0 |     | 3 (2.8%) |     | 1 (2.8%) |     | 1 (0.9%) |
| Akathisia                          |     | 1 (0.9%) |     | 2 (1.8%) |     |        0 |     | 1 (0.9%) |
| Extrapyramidal disorder            |     |        0