Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 143

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 143
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 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 utilize a fixed-flexible dose of LB-102. This trial design allows us to employ two doses of LB-102 in the trial, thereby increasing the chances for a patient to derive clinical benefit from treatment with LB-102, while retaining the advantages of a two-arm trial which is known to mitigate the risk of a high placebo rate. Additionally, flexible dose trials typically have better signal detection than fixed dose trials for depression, as flexible dose trials lower the magnitude of symptom reduction with placebo. We believe LB-102 has the potential to provide improved tolerability and clinical activity in bipolar depression compared to currently available treatments worldwide, which are associated