Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 214

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 214
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-102 in MDD. In the future, we may also
develop LB-102 for other psychiatric disorders, including schizophrenia with predominantly negative symptoms, psychosis and agitation in Alzheimer’s disease, manic episodes of bipolar disorder, as well
as CIAS. We plan to initiate a registrational-quality randomized Phase 2 trial in this indication in the first quarter of 2026, with topline data expected in the first quarter of 2028. Our initial Phase 2 trial will explore the utility of LB-102 in controlling the depressive symptoms of the disease. We may also develop LB-102 as a potential treatment for the manic episodes of bipolar disorder in the future.

We believe LB-102’s strong antagonism of the D, D, and 5HT7 receptors makes it well suited for treating bipolar depression, providing potential to control psychosis and mania through its
effects on Dand potential for antidepressive and pro-cognitive effects through its antagonism of 5HT7 and D. Our Phase 2 trial of LB-102 in acute schizophrenia demonstrated strong antipsychotic activity and suggests opportunities for potential differentiation in
bipolar depression given the observed tolerability profile (low rates of EPS, sedation, and gastrointestinal side effects) and positive impact on cognition. Amisulpride is approved for the treatment of dysthymia, a form of depression, in certain
countries outside of the United States and has been shown to be as effective as certain approved agents for MDD and dysthymia. We believe that results in dysthymia and MDD

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provide strong scientific and clinical rationale for development of LB-102 in the treatment of depressive episodes associated with bipolar disorder or bipolar depression because episodes of major
depression, whether unipolar (as in MDD) or bipolar (as in bipolar depression), are typically characterized by a similar imbalance in the neurotransmitters serotonin, noradrenaline, and dopamine, regardless of the underlying pathophysiology of the
disease.

Additionally, among the four antipsychotics currently approved for schizophrenia and MDD or treatment resistant depression that
were also studied in late-stage bipolar depression trials (quetiapine, cariprazine, aripiprazole, and olanzapine), three out of four, or 75%, generated positive data for the treatment of bipolar depression. There is also widespread use of
amisulpride in bipolar disorder with approximately 3.4% of at least two million monthly prescriptions in Europe