공시 • Mar 28
LB Pharmaceuticals Inc Presents New Analysis From The Phase 2 NOVA-1 Trial Highlighting LB-102’s Potential Impact On Cognitive Performance
LB Pharmaceuticals Inc. announced the presentation of new data further evaluating the effects of LB-102 on cognitive performance in the Phase 2 NOVA-1 clinical trial in patients with acute schizophrenia. LB-102, a novel, once-daily, oral investigational small molecule, is a 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. The post hoc analysis was designed to assess whether the improvement in cognitive performance, as measured by the Global Cognition composite score, was a direct effect of LB-102 or an indirect consequence of the effect of LB-102 on total schizophrenia symptoms. Results of the analysis demonstrated that the cognitive benefit was primarily, and statistically significantly, a direct effect of LB-102. The presentation, titled “LB-102 for Cognition in Patients with Schizophrenia: An Exploratory Post Hoc Analysis from a Randomized, Double-blind, Placebo-controlled Phase 2 Study” was highlighted at the Schizophrenia International Research Society (SIRS) meeting on March 27th in Florence, Italy. In addition, an encore oral presentation titled "LB-102 for Acute Schizophrenia in Adults: Results from the Phase 2 NOVA-1 Clinical Trial, with a Focus on PANSS Marder Factor Scores” was also presented at SIRS. This presentation reviewed an analysis exploring LB-102’s effect on PANSS Marder factor, which provides a more nuanced framework for understanding the complexities of schizophrenia symptoms. This analysis evaluated LB-102’s effects across the five PANSS Marder factors: Positive Symptoms, Negative Symptoms, Disorganized Thought, Hostility/Excitability, and Anxiety/Depression. In the Phase 2 NOVA-1 trial, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial. LB-102 was generally safe and well tolerated, exhibiting a potentially class-leading safety profile with low rates of extrapyramidal symptoms (EPS) (including akathisia), minimal sedation and few gastrointestinal (GI) side effects alongside effects on negative symptoms and cognitive performance. A dose dependent, and statistically significant improvement in the global cognition composite score was observed at all dose levels in a patient population that was not enriched for severe cognitive impairment at baseline. In addition to the oral and poster presentation, the Company sponsored a Satellite Symposium titled “Next-Generation Perspectives in Schizophrenia: Translating Emerging Science Into Practice” featuring John Kane, M.D., Professor, Psychiatry and Molecular Medicine at the Donald and Barbara Zucker School of Medicine and Christoph Correll, M.D., Professor of Child and Adolescent Psychiatry at the Charité-Universitätsmedizin Berlin and Donald and Barbara Zucker School of Medicine. The poster and oral presentations are available on the LB Pharma Publication page on LB Pharmaceuticals website at https://lbpharma.us/. LB-102 is a novel, once-daily, orally administered investigational small molecule and potential first benzamide antipsychotic in the U.S. for the treatment of neuropsychiatric disorders. A methylated derivative of amisulpride, a widely used antipsychotic outside the U.S., LB-102 was developed to retain amisulpride’s benefits while addressing its limitations. LB-102 is a potent and selective antagonist of D2, D3, and 5HT-7 receptors with few off-target effects and broad therapeutic potential across psychosis and mood disorders. 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, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside effects on negative symptoms and cognitive performance. These data underscore LB-102’s potential to address multiple dimensions of neuropsychiatric illness. A Phase 3 clinical trial (NOVA-2) of LB-102 for schizophrenia and a Phase 2 clinical trial (ILLUMINATE-1) of LB-102 for bipolar depression have been initiated, and a Phase 2 trial in adjunctive treatment of MDD is planned. Additional expansion opportunities for LB-102 include predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as other neuropsychiatric diseases.