LB Pharmaceuticals Initiates Phase 2 ILLUMINATE-1 Trial in Bipolar Depression, Expanding LB-102 Development Program

Core Insights - LB Pharmaceuticals has initiated a Phase 2 trial for LB-102, targeting bipolar depression, following positive results in acute schizophrenia trials [2][3] - The company anticipates topline results from the bipolar depression trial in the first quarter of 2028, with a Phase 3 trial for schizophrenia also on track for initiation this quarter [3][4] Company Overview - LB Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for schizophrenia, bipolar depression, and other neuropsychiatric diseases [8] - The lead product candidate, LB-102, is a novel, once-daily oral small molecule that acts as a selective antagonist of D2, D3, and 5HT7 receptors, potentially becoming the first benzamide antipsychotic approved in the U.S. [5][8] Clinical Trial Details - The Phase 2 trial, named ILLUMINATE-1, is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of LB-102 at doses of 25 mg and 50 mg [4] - Approximately 320 patients with bipolar 1 depression will be enrolled across 30 sites in the U.S., with the primary endpoint being the Montgomery–Åsberg Depression Rating Scale (MADRS)-10 at week six [4] Market Context - Bipolar disorder affects around 7 million patients in the U.S. and 40 million globally, with significant unmet needs in treatment options, particularly regarding onset speed and side effects [7] - Current antipsychotic medications have limitations, including adverse events and inadequate efficacy against residual symptoms, highlighting the potential market opportunity for LB-102 [7]