Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 177

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 177
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. Based on existing third-party data investigating amisulpride and a non-racemic form of the
drug as a treatment for several types of depression, including bipolar depression, and the approval of amisulpride in multiple countries outside of the United States for the treatment of dysthymia, a form of depression, we have identified bipolar
depression as our next development opportunity for LB-102. There is wide use of amisulpride in bipolar disorder with approximately 3.4% of at least two million monthly 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 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