LB-102 Shows Promise as Potential First-in-Class Benzamide Antipsychotic for Schizophrenia in US
LB Pharmaceuticals announced positive Phase II results for LB-102, a once-daily oral benzamide antipsychotic, in adults with acute schizophrenia.
The trial met its primary endpoint, showing statistically significant reductions in PANSS total scores compared to placebo across all tested doses:
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)
LB-102 was generally safe and well-tolerated, with low rates of side effects like extrapyramidal symptoms, sedation, and weight gain.
The company plans to advance LB-102 to Phase III trials, potentially making it the first benzamide antipsychotic available in the US.
LB-102 is a methylated derivative of amisulpride, an antipsychotic used outside the US for decades.
The positive results suggest LB-102 could provide a new treatment option for schizophrenia patients in the US with a favorable efficacy and safety profile.