LB-102: Promising Phase 2 Results Revive Benzamide Antipsychotics for Schizophrenia Treatment in the US

LB Pharmaceuticals announced positive Phase 2 results for LB-102, a potential first-in-class benzamide antipsychotic for schizophrenia treatment in the US13.

The NOVA1 trial enrolled 359 patients with acute schizophrenia and tested three doses of LB-102 (50 mg, 75 mg, and 100 mg) against placebo13.

All three doses showed statistically significant reductions in PANSS total scores compared to placebo:

50 mg:
5.0-point reduction (p=0.0009)

75 mg:
4.7-point reduction (p=0.0022)

100 mg:
6.8-point reduction (p=0.0017)1315

LB-102 demonstrated a favorable safety profile with low incidence of extrapyramidal symptoms, minimal QT prolongation, and average weight gain of 2 kg13.

The drug is a methylated derivative of amisulpride, a benzamide antipsychotic widely used outside the US15.

LB-102 is designed for once-daily dosing, potentially improving upon amisulpride's typical twice-daily regimen315.

Based on these results, LB Pharmaceuticals plans to advance LB-102 to Phase 3 clinical development in late 2025 or early 20261315.

The company also aims to explore LB-102's potential in other psychiatric indications and develop a long-acting injectable formulation13.

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

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