Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 145

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 145
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 2 trial will explore the utility of LB-102 in controlling the depressive symptoms of the disease. We plan to initiate this potentially registrational Phase 2 trial in bipolar depression in the first quarter of 2026 with topline data expected in the first quarter of 2028. We believe LB-102’s strong antagonism of the D2, D3, and 5HT7 receptors makes it well suited for treating bipolar depression, providing potential to control psychosis and mania through its effects on D2 and potential for antidepressive and pro-cognitive effects through its antagonism of 5HT7 and D3. 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 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. There is wide use of amisulpride in bipolar disorder with approximately 3.4% of at least 2 million prescriptions written for this indication in a select group of European countries including Germany, France, Italy, Spain, and several others. A non-racemic form of amisulpride also showed antidepressant activity in two independent third-party, placebo-controlled bipolar depression trials with an approximately 17- to 18-point reduction in Montgomery—Åsberg Depression Rating Scale, or MADRS, from baseline observed across these studies. Additionally, among the four antipsychotics 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. Our planned Phase 2 trial for bipolar depression will