Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 169

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 169
---
 amisulpride, our data suggest that approximately 60% are for schizophrenia and schizoaffective disorders,
approximately 20% are for mood disorders, approximately 14% are for anxiety, and the remainder are for a variety of other indications. We developed LB-102 in order to address the limitations of amisulpride
with a differentiated therapeutic profile and strong intellectual property protection. We believe LB-102’s mechanism of action, data from our recently completed Phase 2 trial of LB-102 in acute schizophrenia, and the legacy of clinical experience with amisulpride support the continued development of LB-102 in schizophrenia and bipolar depression. If
successful in treating bipolar depression, we may also develop LB-102 in the treatment of major depressive disorder, or MDD. In the future, we may also develop LB-102
for the treatment of other neuropsychiatric disorders, including schizophrenia with predominantly negative symptoms, Alzheimer’s disease-related agitation and psychosis, manic episodes associated with bipolar disorder, and cognitive impairment
associated with schizophrenia, or CIAS. We believe that LB-102, if approved, can become a mainstay of psychiatric practice by offering a potentially attractive alternative to branded and generic therapeutics
for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases.

Our product candidate, LB-102, is a Phase 3-ready oral, small molecule for the treatment of acute schizophrenia, defined as a sudden and severe episode of psychotic symptoms, characterized by
hallucinations, delusions, and other positive symptoms. Schizophrenia is a chronic, severe, complex, and debilitating psychiatric disorder that affects approximately 1% of the U.S. population and is a leading cause of disability. Symptoms are
divided into three categories: (i) psychotic or positive symptoms, which include delusions, hallucinations, thought disorder, and movement disorder; (ii) negative symptoms, which include lack of motivation, interest, or enjoyment in daily
activities, withdrawal from social life, and difficulty showing emotions; and (iii) cognitive symptoms, which encompass problems with attention, concentration, and memory. The disease is associated with increased mortality, with approximately
5% of schizophrenia patients dying by suicide, and average overall life expectancy decreasing by as much as 29 years compared to the general population. There is currently no cure for schizophrenia, which means the disease must be managed with
life-long therapy, increasing the importance of therapies that can improve compliance rates and dosing challenges.

In January 2025, we
ann