Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 192

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 192
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. Despite the burdensome side effects associated with these antipsychotic drugs, they are still commonly used, with patients frequently switching between different
medications in search of the right balance of tolerability and efficacy. We believe a medication with an improved tolerability profile, increased efficacy, including with respect to negative symptoms or cognition, or both, have the potential to
provide a much-needed alternative to currently available therapies. We also believe a simple administration profile, once-daily dosing with no food effect, would provide a significant advantage as it has the potential to improve patient adherence
and, therefore, improve long-term 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.

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, and predominantly negative symptoms of schizophrenia. 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