Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 180

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 180
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ing or the need to be taken with food.

Together, these limitations lead to significant issues with patient adherence. One study showed that
one-third of patients admitted to the hospital after their first psychotic episode of schizophrenia were non-adherent to their treatment six months after discharge. A
multitude of studies have shown the serious outcomes that accompany non-adherence to medication, including impairment, hospitalization, higher risk of suicide, longer time to remission, poorer prognosis, loss
of job, dangerous behavior, arrest, violence, drug and alcohol consumption, psychiatric emergences, poor mental performance, and low satisfaction with life. Interruptions in treatment as short as one to 10 days has been associated with an increased
risk of hospitalization.

Nearly 50% of all schizophrenia patients fail to respond adequately to existing therapies, many of which have
limited efficacy against the range of symptoms associated with the disease. Most antipsychotic drugs are

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associated with significant side effects that drive high rates of treatment discontinuation. Approximately 74% of schizophrenia patients discontinue their medications within 18 months of starting treatment due to their perceived lack of efficacy or burdensome side effects. Since these medications only treat symptoms of schizophrenia and cannot eliminate the underlying pathology, their discontinuation results in symptom recurrence. As a result of these high rates of discontinuation, there is a significant amount of switching therapeutic treatments. A therapy with sufficient efficacy, tolerability and ease of use which would support a patient’s efforts to remain compliant could provide significant benefit over currently available therapies. In the table below, we show the efficacy and side effect profiles of branded antipsychotic drugs approved for treatment of schizophrenia based on the approved labels.

| Drug    |     | Mechanism of                      
 Action                            |     | Baseline                      
 PANSS                         |     | Reduction in                         
 PANSS                                
 vs. Baseline                         |     | Placebo-Corrected                   
 Reduction                           
 in                                  
 PANSS                               |     | Notable Lab                                                                                                                                   
 Findings and                                                                                                                                  
 Side Effects                                                                                                                                  |     | Recommended        
 Dosage             |     | Dosing                                                     
 Frequency                                                  |
| Caplyta |     | Dopamine Receptor Antagonist      |     | 88.1 (Trial 1) 90.0 (Trial 2) |     | 13.2 (Trial 1) 14.5 (Trial           
 2)                                   |     | 5.8 (Trial 1)                       
 4.2 (Trial 2)