LB Pharmaceuticals Initiates Phase 2 Trial Evaluating Efficacy And Safety Of LB-102 In Patients With Bipolar Depression; Topline Data Expected In 1Q 2028

Phase 2 bipolar depression trial initiation follows positive Phase 2 results in acute schizophrenia

NEW YORK, Jan. 26, 2026 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc ("LB Pharmaceuticals" or the "Company") (NASDAQ:LBRX), a clinical-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, and other neuropsychiatric diseases, today announced the initiation of a Phase 2 trial evaluating the efficacy and safety of LB-102 in patients with bipolar depression. LB-102, a novel, once-daily, oral investigational small molecule, is a potent and selective antagonist of D2, D3, and 5HT7 receptors that is being advanced as a potential first benzamide antipsychotic in the U.S. for the treatment of neuropsychiatric disorders.

Phase 2 Bipolar Depression ILLUMINATE-1 Trial Design

The Phase 2 trial is a multi-center, randomized, double-blind, placebo-controlled trial with fixed- and flexible-doses and is designed to evaluate the efficacy and safety of two doses (25 mg and 50 mg given once daily) of LB-102 for the treatment of bipolar depression. The two-arm, six-week, outpatient trial is expected to enroll approximately 320 patients with bipolar 1 depression at approximately 30 sites in the U.S. Patients will be randomized 1:1 to receive either LB-102 or placebo. The primary endpoint is the Montgomery–Åsberg Depression Rating Scale (MADRS)-10 at week six. The primary statistical analysis will compare results from all patients receiving LB-102, regardless of dose, with placebo. Secondary endpoints include MADRS-6, and CGI-BP, cognition, and anhedonia, as well as safety and tolerability. Topline results from the trial are anticipated in the first quarter of 2028.