(RTTNews) - LB Pharmaceuticals Inc. (LBRX), a clinical-stage biopharmaceutical company, announced the initiation of a Phase 2 trial of investigational drug LB-102 in bipolar depression, dubbed ILLUMINATE-1.
The trial initiation is backed by positive Phase 2 results of LB-102 in acute schizophrenia.
LB-102 is LB Pharma's lead candidate, a once-daily oral investigational small molecule with the potential to be the first U.S.-approved benzamide antipsychotic for neuropsychiatric disorders. It was developed to retain amisulpride's benefits while addressing its limitations. (Amisulpride is a widely used antipsychotics outside the U.S.)
The Phase 2 ILLUMINATE-1 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.
In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia.
In this trial for acute schizophrenia, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid and sustained benefit. Notably LB-102 is also advancing into a Phase 3 clinical trial for schizophrenia.
Bipolar disorder is a chronic, debilitating mood disorder in which patients alternate between manic and depressive states. There are approximately 7 million patients in the U.S. and 40 million patients worldwide suffering from bipolar disorder.
Antipsychotic medications, with or without mood stabilisers, are a mainstay of therapy for bipolar depression due to their ability to control depressive symptoms while preventing the emergence of mania.
LB-102, if approved, has the potential to become a key support of psychiatric practice by offering a balanced clinical activity and tolerability profile for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases.
"Our year is off to a strong start, and the initiation of this Phase 2 trial in patients with bipolar depression marks an important step in our strategy to expand the potential of LB-102 for the treatment of mood disorders," said Heather Turner, Chief Executive Officer of LB Pharmaceuticals.
He also added that LB Pharmaceuticals looks forward to late-stage clinical catalysts, including results from this Phase 2 trial in the first quarter of 2028, and from their planned Phase 3 trial in schizophrenia, which remains on track to initiate this quarter with results expected in the second half of 2027.
LBRX has traded in a range of $13.36 to $24.46 in the last 1 year. The stock is currently trading at
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