Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 171

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 171
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imaging trial, we observed that LB-102 achieved a level of dopamine receptor occupancy in the brain of approximately 70% (50 mg dose) and approximately 80% (100 mg dose) under steady-state conditions;
typically, 60% to 80% dopamine receptor occupancy is desired to treat schizophrenia. The dopamine receptor occupancy levels seen in the imaging trial at 50 mg of LB-102 are approximately equivalent to those
observed with 300 to 400 mg of amisulpride. By dosing LB-102 at a lower level, we are aiming to decrease side effects common to amisulpride and other antipsychotic drugs currently used to treat schizophrenia.
We believe that fewer side effects of a drug may lead to stronger adherence, continued use of the drug, and therefore, better efficacy results and long-term control of the disease. Because each relapse of psychotic symptoms can result in a
functional deterioration from which the patient does not fully recover, long-term control of the disease is a key treatment goal.

While
our current Phase 3 trial is designed to investigate LB-102 as a treatment for people experiencing the acute phase, or positive symptoms, of schizophrenia, we believe
LB-102 also has potential to addresspredominantly negative symptoms, an indication with significantly fewer treatment options as well as CIAS, an indication for which there are no approved therapies. We
believe that our data with LB-102 as well as data previously generated with amisulpride support the further investigation of LB-102 in these settings and that, if
positive, such data have the potential to further differentiate LB-102 from other drugs available for schizophrenia. A literature review published in 2002 showed that amisulpride may yield more effective
results in some specific outcomes related to efficacy, such as improvement of negative symptoms of schizophrenia when compared to typical antipsychotic drugs. Additionally, our Phase 2 trial data showed a statistically significant impact on negative
symptoms versus placebo at the 50 mg dose even though the inclusion criteria enriched for patients experiencing predominantly positive symptoms of schizophrenia. An exploratory post-hoc analysis of our Phase 2
data on the treatment effect in patients with negative symptoms at baseline (i.e., those patients with a PANSS Negative Subscore greater than or equal to 24) yielded similar results with a statistically significant impact on negative symptoms versus
placebo at the 50 mg dose. We find these results highly encouraging and plan to explore options to advance LB-102 in this