LB Pharma’s Phase II Success Revives Promising Antipsychotic Class for US Patients with Schizophrenia

LB-102 is a novel once-daily oral antipsychotic being developed as a potential first-in-class benzamide for schizophrenia in the US13.

The Phase II NOVA1 trial met its primary endpoint, showing statistically significant reductions in PANSS total scores compared to placebo across all tested doses13.

At 4 weeks, the 50 mg dose reduced PANSS scores by 5 points vs placebo (p=0.0009), 75 mg by 4.7 points (p=0.0022), and 100 mg by 6.8 points (p=0.0017)13.

LB-102 was generally safe and well-tolerated, with low rates of side effects like extrapyramidal symptoms, sedation, and weight gain13.

The positive results support advancing LB-102 to Phase III trials, which are expected to start in late 2025 or early 2026310.

LB-102 is a methylated derivative of amisulpride, a benzamide antipsychotic used outside the US, and may offer improved efficacy and tolerability10.

If approved, LB-102 would be the first benzamide antipsychotic available in the US, potentially providing a new treatment option for schizophrenia patients13.

Sources:

1. https://www.psychiatrictimes.com/view/lb-102-sees-positive-phase-2-topline-results

3. https://www.biospace.com/press-releases/lb-pharmaceuticals-announces-positive-topline-results-from-phase-2-trial-of-lb-102-in-schizophrenia

10. https://www.fiercebiotech.com/biotech/lb-pharmas-twist-old-sanofi-drug-passes-schizophrenia-test-teeing-phase-3-push