Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 174

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 174
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 placebo rate observed in this trial was
higher than the average placebo rate from a recent set of bipolar depression trials which was an approximately 12-point reduction in MADRS from baseline. We believe that the high placebo rate in this trial was
in part a result of poor trial design and conduct. A Phase 3 trial was subsequently initiated by the same third party with non-racemic amisulpride and though the trial was terminated prior to completion,
results from 82 patients enrolled in the trial were reported. These results showed a 4.0 to 6.4-point MADRS delta versus placebo and an approximately 14 to 17-point
reduction in MADRS versus baseline in the two treatment arms. Amisulpride and the non-racemic form studied in these two trials have been shown to be substantially similar in
pre-clinical models. Additionally, amisulpride has been shown to be effective in clinical trials addressing other forms of depression, such as in a 1999 head-to-head trial conducted by a third party in dysthymia and major depression which showed amisulpride and another study drug each leading to a statistically significant improvement over placebo on the
MADRS. A 2001 head-to-head trial conducted by a third party also found amisulpride to be as clinically effective as sertraline, a commonly used antidepressant, in
treating dysthymia, and a 2002 head-to-head trial conducted by a third party found amisulpride to be as clinically effective as paroxetine, another commonly used
antidepressant.

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It is widely recognized that episodes of major depression whether unipolar (as in MDD)
or bipolar (as in bipolar depression) are characterized by a similar imbalance in the neurotransmitters serotonin, noradrenaline, and dopamine, regardless of the underlying pathophysiology of the disease. 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. We believe that the approval of amisulpride in the United Kingdom for the treatment of psychosis and mania serves as additional supportive evidence for the broader utility of LB-102 to
treat neuropsychiatric disorders.

We plan to initiate this