Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 205

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 205
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 to employ two doses of LB-102 in the trial, thereby increasing the
chances for a patient to derive clinical benefit from treatment with LB-102, while retaining the advantages of a two-arm trial, which is known to mitigate the risk of a
high placebo rate. The primary endpoint is expected to be MADRS-10 and will compare all LB-102 treated patients regardless of the dose received versus placebo. Secondary
endpoints are expected to include MADRS-6, CGI-BP-S, cognition, anhedonia, as well as safety and tolerability. We have designed
this trial to highlight what we believe will be differentiating attributes of LB-102 in bipolar depression. Specifically, we are targeting competitive MADRS-10 versus
other approved agents, improved tolerability as evidenced by lower rates of sedation and gastrointestinal side effects compared with other approved agents, a rate of EPS consistent with or lower than what we observed in our schizophrenia Phase 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.

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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.

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