Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 203

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 203
---
 form of depression, 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.

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,

144

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 written for this indication. A non-racemic form of amisulpride showed strong antidepressant activity in two independent third-party,
placebo-controlled bipolar depression trials with an approximately 17 to 18-point reduction in MADRS from baseline observed in each trial. The non-racemic form of
amisulpride has been shown to be substantially similar to amisulpride in preclinical models. 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 with troubling adverse events and insufficient efficacy for certain symptoms, including cognitive impairment associated with the disease.

Planned Phase 2 Trial of LB-102in Bipolar Depression

We are planning to initiate a Phase 2 trial of LB-102 in participants with depressive episodes
associated with bipolar 1 disorder or bipolar depression