Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 200

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 200
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 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 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 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. 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 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 PANSS ratings to ensure consistency and quality control throughout the trial. Secondary endpoints will include CGI-S,PANSS positive and negative subscales, Marder factor scores, the Personal and Social Performance Scale, or PSP, and cognition as well as safety and tolerability. We believe that the 6-weekduration of this Phase 3 trial has the potential to further improve PANSS reductions observed following treatment with LB-102given that in our Phase 2 trial, the PANSS score in the LB-102treated arms declined at a faster rate than placebo through the 28-dayduration of our Phase 2 trial. We expect to report topline data from the trial in the second half of 2027. Concurrently with the Phase 3 trial we expect to run an open label trial to accrue the requisite safety population required to support NDA submission as well as other clinical and non-clinical