Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 181

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 181
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) 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 indication. For example, we have developed a synopsis for a Phase 2 trial in patients with predominantly negative symptoms of
schizophrenia and expect to seek regulatory guidance on the design of this trial in 2026 to establish a clinical registration path in this setting. We also expect to generate additional negative symptoms data in our planned Phase 3 trial. We also
plan to further explore the impact of LB-102 on cognition in patients with schizophrenia both clinically and pre-clinically. For example, concurrently with our Phase 3
trial in patients with acute schizophrenia, we expect to initiate an open label trial in patients with stable schizophrenia that will enroll both patients who participated in the Phase 3 trial as well as patients who did not. Although the primary
objective of this trial is to collect the requisite safety data required for an NDA submission, we also expect to collect efficacy data in certain subsets of patients enrolled in this trial. Efficacy measures will include periodic assessments of
cognition as well as open label assessments of improvements in positive and negative symptoms, including in patients with prominent negative symptoms at enrollment in the trial. Although we do not expect data from this open label trial to lead to
product label claims

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without additional randomized clinical trials, we believe these data have the potential to further support the differentiation of LB-102 and expect these
data to provide publishable valuable insights as we consider further investigating LB-102 as a potential treatment for CIAS as well as in patients with predominantly negative symptoms of schizophrenia.
Following the potential approval for the treatment of schizophrenia, we may also consider conducting another Phase 3 trial in acute schizophrenia where LB-102 is used as an adjunctive therapy.

Beyond the potential advantages in treating schizophrenia, we believe there is significant potential for
LB-102 as a treatment for mood disorders and other neuropsychiatric diseases. Based on existing third-party data investigating amisulpride and a non-racemic form of the
drug as a treatment for several types of depression, including bipolar depression, and the approval of amisulpride in multiple countries outside of the United States for the treatment of dysthymia, a form of depression, we have identified bipolar
depression as our next development opportunity for LB-102. There is wide use of amisulpride in bipolar disorder with approximately