Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 210

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 210
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 2 trial, and the potential to demonstrate improvements in anhedonia and cognition versus placebo, which we believe could address important unmet needs in this disease. Following a successful Phase 2 trial,
we believe that a single additional Phase 3 trial could support an approval for LB-102 as a monotherapy to treat bipolar depression. We expect an additional Phase 3 trial to be required to support approval as an adjunctive therapy for bipolar
depression. Based on historical precedent, we expect to be able to utilize the safety dataset that we generate from our open label acute schizophrenia trial to support a potential approval for LB-102 in bipolar depression as the doses utilized in
our bipolar depression trial will be equivalent to or lower than those utilized in our acute schizophrenia trials.

Flexible dose trials
typically have better signal detection than fixed dose trials for depression. A third-party study from 2003 examined if the dosing schedule (either a fixed dose or a flexible dose), in an antidepressant clinical trial affects the frequency with
which antidepressants show statistical superiority over placebo. In flexible dose trials, 59.6% (34/57) of the antidepressant treatment arms were statistically significant compared to placebo. In contrast, in the fixed dose trials, only 31.4%
(11/35) of the antidepressant treatment arms were statistically significant compared to placebo. These data suggest a significantly lower magnitude of symptom reduction with placebo in flexible dose trials compared to fixed dose trials. To further
reduce the potential for an elevated placebo rate, we expect to employ many of the same strategies which proved effective in our Phase 2 acute schizophrenia trial including consistent, frequent, and close engagement with clinical sites, the use of
two third-party vendors (including the one used in our Phase 2 trial) to help identify and exclude professional patients from the trial, and a centralized review of MADRS ratings to ensure consistency and quality control throughout the trial. We
also expect to utilize remote structured assessments to enhance enrollment precision in our clinical trial, which has been shown to reduce placebo response rates.

Future DevelopmentOpportunities of LB-102

Potential Additional Indications for LB-102

In addition to schizophrenia and bipolar depression, we are exploring the possibility of testing LB-102
in other neuropsychiatric disorders, such as major depressive disorder, psychosis and agitation in Alzheimer’s disease, predominantly negative symptoms of schizophrenia, and CIAS.

Based on existing third-party data investigating amisulpride and a non-racemic form of the drug as a