Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 173

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 173
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emic form of amisulpride showed 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 across these studies. The non-racemic form of amisulpride was also shown to be substantially similar to amisulpride in preclinical models. We also believe that the strength and selectivity of our binding profile for each of the D, D, and 5HT7 receptors suggests that LB-102 is potentially well suited for development in bipolar
depression since Dmediates effects on psychosis and mania and 5HT7 and D mediate effects on depression and cognition.

There are two types of bipolar disorder, distinguished as bipolar 1 and 2, which are characterized by chronically occurring episodes of mania
or hypomania alternating with depression. A person diagnosed with bipolar 1 disorder experiences a manic episode defined as a distinct period of persistently elevated or irritable mood with increased activity or energy lasting for at least seven
days or requiring hospitalization. The manic episode may be preceded or followed by a hypomanic or major depressive episode. A bipolar 2 disorder diagnosis is based on experiencing a hypomanic episode and major depressive episode without a manic
episode. Manic episodes are markedly more severe than hypomanic episodes. It is estimated that 2.8%, or approximately seven million Americans, experience bipolar disorder in a year. For those living with bipolar disorder, an estimated 82.9% have
serious impairment due to the disease, the highest percent of serious impairment among all mood disorders, indicating there is significant need for new and better treatment options.

In a 2022 placebo-controlled proof-of-concept trial conducted
by a third party in 341 patients across U.S., European, and Japanese clinical sites, non-racemic amisulpride demonstrated meaningful improvement over placebo on the MADRS in treating bipolar depression.
Although the trial did not meet its primary endpoint, which was defined as MADRS delta versus placebo in United States and European patients, the results when analyzed for all patients across all geographies demonstrated a statistically significant
benefit versus placebo in favor of non-racemic amisulpride with a 3.4 to 3.7-point MADRS delta versus placebo and an approximately
18-point reduction in MADRS versus baseline in each of the two treatment arms. The mean reduction from baseline in the placebo arm in this trial was 14.3 points. The