Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 204

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 204
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 mg  |     |                       0.26 |     |  0.0476 |     | 84 |
| 75 mg  |     |                       0.41 |     |  0.0027 |     | 74 |
| 100 mg |     |                       0.66 |     |  0.0018 |     | 20 |

We believe that the magnitude of cognitive improvement and dose-dependent effect observed in this trial supports the further evaluation of the potential cognitive impacts of LB-102in schizophrenia including in patients who have been stabilized with respect to positive symptoms of the disease. We also expect to study cognition in other diseases where cognitive impairment is well recognized to be a domain of the disease, including bipolar depression. We are also encouraged by the improvements observed in cognition in this trial and intend to further investigate the effects of LB-102on cognition in both schizophrenia and bipolar depression. Improvements in cognition, if replicated in our subsequent clinical trials, have the potential to further support the differentiation of LB-102. Planned Phase 3 Trial of LB-102in Acute Schizophrenia and Additional NDA-EnablingStudies We are planning to initiate a six-weekPhase 3 trial of LB-102in participants with acute schizophrenia in the first quarter of 2026, which, if positive, may be sufficient to support a regulatory approval application along with our Phase 2 trial and other planned NDA-enablingstudies. The Phase 3 trial is anticipated to be a three-arm,inpatient, double-blinded, placebo-controlled, oral once-daily dose of LB-102in patients with acute schizophrenia, with a six-weektreatment duration. We plan to study the effects of 50 mg LB-102or 100 mg LB-102versus placebo in this trial, and patients will be randomized in a 1:1:1 ratio across the three arms of the trial. The sample size will be approximately 400 patients, and we plan to conduct this trial entirely in the United States at approximately 25 sites, a similar number of sites as were utilized in our Phase 2 acute schizophrenia trial. We expect there to be significant overlap between the sites utilized in our Phase 2 trial and those we plan to utilize in the Phase 3 trial. The primary endpoint of the trial is anticipated to be change from baseline in PANSS at Day 42. To mitigate the risk of an elevated placebo response in this trial, we expect to employ the same strategies which proved effective in our