LB Pharma’s Phase II Success Revitalizes Benzamide Antipsychotics for US Schizophrenia Treatment
LB Pharmaceuticals announced positive Phase II results for LB-102, a potential first-in-class benzamide antipsychotic for schizophrenia treatment in the US13.
The trial met its primary endpoint, showing statistically significant reductions in PANSS total scores across all tested doses (50 mg, 75 mg, and 100 mg) compared to placebo13.
LB-102 demonstrated a favorable safety and tolerability profile, with low incidence of extrapyramidal symptoms, minimal QT interval prolongation, and limited weight gain14.
The drug is a methylated derivative of amisulpride, a benzamide antipsychotic widely used outside the US but never approved by the FDA10.
LB-102's once-daily dosing and efficacy profile could potentially address unmet needs in schizophrenia treatment310.
Based on these results, LB Pharmaceuticals plans to advance LB-102 into Phase III clinical development, with trials expected to begin in late 2025 or early 202613.
The success of LB-102 could revive interest in the benzamide class of antipsychotics, which has been largely dormant in the US market10.
Sources:
1. https://www.drugtargetreview.com/news/155351/lb-pharma-positive-schizophrenia-trial/
3. https://www.biospace.com/press-releases/lb-pharmaceuticals-announces-positive-topline-results-from-phase-2-trial-of-lb-102-in-schizophrenia
4. https://www.psychiatrictimes.com/view/lb-102-sees-positive-phase-2-topline-results
10. https://www.fiercebiotech.com/biotech/lb-pharmas-twist-old-sanofi-drug-passes-schizophrenia-test-teeing-phase-3-push