Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 182

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 182
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 outcomes.
Additionally, an LAI has the potential to further simplify the patient experience and improve medication adherence. Currently, there are no LAIs available for Caplyta, Rexulti or Vraylar although several are in development. In addition, there are no
LAIs among the benzamide class of antipsychotic drugs currently available or in development worldwide.

Despite the availability of
several generic and branded treatments for schizophrenia, there remains a significant unmet need. Only 20% of people with schizophrenia report favorable treatment outcomes. The remaining population experiences numerous psychotic episodes, chronic
symptoms and a poor response to antipsychotic drugs. Additionally, patients who experience predominantly negative symptoms and those with treatment-resistant schizophrenia live with a significant disease burden that cannot be sufficiently alleviated
with currently available treatments, and there are no approved therapies for cognitive impairment associated with schizophrenia. We believe a treatment that is effective, tolerable, supports adherence in a fragile population and can address negative
and resistant symptoms could become a cornerstone of schizophrenia treatment. We believe LB-102 has the potential to meet this profile, given its derivation from amisulpride, an antipsychotic drug that
possesses many of these attributes and has one of the lowest all cause discontinuation rates among approved antipsychotics.

Development of LB-102:Improving upon Amisulpride

Amisulpride Overview

Amisulpride is a dopamine receptor antagonist originally developed in France in the 1980s and is approved in more than 50 countries worldwide
(not including the United States) for the treatment of schizophrenia and, in certain countries outside of the United States, for the treatment of dysthymia, a form of depression. In 2000, Sanofi S.A., the manufacturer of Solian, the branded version
of amisulpride, announced it would not pursue approval for schizophrenia in the United States because the development and regulatory requirements of the FDA were incompatible with its patent coverage on the drug.

Amisulpride in Schizophrenia

In multiple
third-party studies comparing the clinical efficacy of antipsychotic drugs on schizophrenia, amisulpride consistently scored near the top. For example, a 2019 Lancet meta-analysis of clinical trials, which included over 54,000 subjects and 32
medications, found that amisulpride had the highest efficacy as measured by effect on positive symptoms and was second only to clozapine at reducing overall symptoms of schizophrenia. This