Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 216

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 216
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 benefit. This is the
dosing model that was used by Vraylar and Latuda, both of which are approved for schizophrenia and bipolar depression. In contrast, Caplyta, another drug approved for use in both schizophrenia and bipolar depression, utilized the same dose in both
indications, in part because of its low rates of EPS. In selecting doses for our Phase 2 trial, we are blending these two paradigms. We plan to initiate all patients on half the lowest dose used in our acute schizophrenia trial (25 mg). Importantly,
we believe that results of our Phase 2 acute schizophrenia trial, which demonstrated <1% EPS and no sedation even at 50 mg, provide us an opportunity to explore that dose in bipolar depression similar to Caplyta, which used a single dose across
both indications. All patients randomized to receive LB-102 will begin treatment at 25 mg for the first three weeks of the trial. At the end of Week 3, if a patient has not improved based on a protocol guided
set of specific items in the Clinical Global Impression-Bipolar Illness, or CGI-BP, scale and the patient is tolerating the drug, the dose of LB-102 will be increased in
this patient to 50 mg for the remaining three weeks of the trial, subject to an allowance for up to one dose reduction for safety reasons. This trial design allows us to evaluate 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,

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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