LB-102 Shows Promise as Potential First-in-Class Benzamide Antipsychotic for Schizophrenia
LB-102 is a once-daily oral antipsychotic being developed as a potential first-in-class benzamide antipsychotic in the US for schizophrenia treatment.
The Phase 2 NOVA1 trial met its primary endpoint, showing statistically significant reductions in PANSS total scores compared to placebo across all tested doses (50 mg, 75 mg, 100 mg).
Effect sizes ranged from 0.41 to 0.83 across the dose groups, with PANSS score reductions of 4.7 to 6.8 points versus placebo.
LB-102 was generally safe and well-tolerated, with low incidence of common antipsychotic side effects like extrapyramidal symptoms, prolactin elevation, and QT prolongation.
Average weight gain was 2 kg and only one case of sedation was reported across 251 treated patients.
LB-102 is a methylated derivative of amisulpride, designed to potentially improve on amisulpride's efficacy and tolerability profile.
Based on these positive results, LB Pharma plans to advance LB-102 to Phase 3 trials for schizophrenia.
The company also aims to explore LB-102 for other psychiatric indications and develop a long-acting injectable formulation.
If approved, LB-102 would be the first benzamide antipsychotic available in the US, potentially offering a new treatment option for schizophrenia patients.