Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 197

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 197
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 Movement Scale, or AIMS. The majority of TEAEs were mostly transient and mild to moderate in severity.
TEAEs were defined as any adverse event that began on or after the first dose of trial medication, or any pre-existing condition that reappeared during the treatment period and up to 14 days following the last
dose. TEAEs were reported in 56% (placebo), 69% (50 mg), 57% (75 mg), and 75% (100 mg)

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of participants. The most commonly reported TEAEs were psychiatric neurological conditions that many participants were experiencing at the time of enrollment. Weight increase was the only TEAE to occur in at least 5% of the total population and at a rate at least twice that observed with placebo (LB-10250 mg at 12.1%; LB-10275 mg at 7.4%; LB-102100 mg at 8.3%; placebo at 3.7%). The discontinuation rate reached 18% during the treatment period (four weeks) and 27% when taking into account up to 14 days following the last dose. Despite the weight gain observed in the four-week trial, no clinically meaningful signal in metabolic parameters such as cholesterol, LDL, HDL, triglycerides or fasting glucose were observed. The most common comorbid medical conditions at baseline were insomnia (74.1%), anxiety (58.8%), headache (40.1%), depression (32.9%), and agitation (30.1%). Comorbid conditions at study entry enriched the reporting of TEAEs in our trial. Because TEAEs were defined as any adverse event that began on or after the first dose of trial medication, or any pre-existingcondition that reappeared during the treatment period and up to 14 days following the last dose, the rates of certain AEs, such as insomnia, appear elevated in both placebo and LB-102patients. Change from baseline to Week 4 in SAS, AIMS, and BARS demonstrated no difference between treatment arms. The following table summarizes the adverse events from the trial:

| Adverse Events                         |     | 50 mg      
 (N=107)    |     | 75 mg      
 (N=108)    |     | 100 mg     
 (N=36)     |     | Placebo (N=108) |
| Insomnia                               |     | 27 (25.2%) |     | 23 (21.3%)