Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 193

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 193
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 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 analysis also found that amisulpride was 20% more effective at reducing overall symptoms of schizophrenia compared to risperidone, which is a first-line treatment for schizophrenia in the United
States. A 2020 Lancet Psychiatry report of a head-to-head long-term study showed amisulpride to have greater reduction in PANSS

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score from baseline compared to first-line treatments of aripiprazole and olanzapine. In addition, a 2018 systematic review and meta-analysis across 21 randomized, controlled third-party trials
showed that in their analysis across these trials, amisulpride was the only antipsychotic drug that outperformed placebo in the treatment of patients who suffer from predominantly negative symptoms.

The following chart shows the antipsychotic efficacy as measured by overall average change in symptoms from the 2019 Lancet meta-analysis of
clinical trials on antipsychotic drugs.

Amisulpride was ranked as one of the most effective antipsychotic drugs in the 2019 Lancet meta-analysis of clinical trials on antipsychotic drugs.

The following chart shows the antipsychotic efficacy as measured by average change in
positive symptoms (left) and negative symptoms, a notoriously difficult aspect of the disease to treat, (right) from the 2019 Lancet meta-analysis of clinical trials on antipsychotic drugs.

Amisulpride was ranked the most effective antipsychotic drug in treating positive symptoms and third most effective in addressing negative symptoms of schizophrenia.

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In 2024, Cobenfy was approved for use in schizophrenia. A 2025 third-party study in European
Neuropsychopharmacology highlighted that its overall treatment effect on symptoms was 0.56 using an approach similar to that which was used in the 2019 Lancet meta-analysis. In the table below, we have included the treatment effect of Cobenfy
together with those antipsychotic drugs reviewed in the 2019 Lancet meta-analysis for comparison purposes. This table shows how amis