LB-102 for the Treatment of Acutely Exacerbated Schizophrenia: Insights From the Principal Investigator

John Kane, MD, shared new positive phase 2 data on N-methyl amisulpride (LB-102) for the treatment of patients with acutely exacerbated schizophrenia at the 2025 Annual Congress of the Schizophrenia International Research Society. LB-102 is a once-daily orally administered novel dopamine D_2/3/5-HT₇ inhibitor and potential first-in-class benzamide antipsychotic, in adult patients with acute schizophrenia.

Kane served as the principal investigator of NOVA, a phase 2 randomized, double-blind, placebo-controlled, multi-center inpatient trial evaluating the efficacy and safety of a once-daily oral dose of LB-102 in 359 adults, aged 18 to 55 with DSM-5 diagnosis of acutely exacerbated schizophrenia. Initial data from NOVA were shared in early January; this presentation shares additional data from this trial.

The primary endpoint of NOVA—a clinically meaningful change in Positive and Negative Syndrome Scale (PANSS) total score at week 4—was achieved with a high degree of statistical significance at all doses. The study also measured mean change from baseline in Clinical Global Impression of Severity (CGI-S) score, which rates illness severity on a scale from 1 (normal) to 7 (extremely ill) and has been shown to correlate with PANSS, as a secondary endpoint. At week 4 of the study, participants treated with the 50 mg dose (n=107) achieved a mean change in baseline CGI-S score of -0.72 compared with placebo (P=0.0008). Those who received the 75 mg dose (n=108) achieved a mean change in baseline CGI-S score of -0.67 compared with placebo (P=0.0048). Treatment with the exploratory dose of 100 mg (n=36) resulted in a mean change in baseline CGI-S score of -0.84 compared with placebo (P=0.0026).

"The results are very encouraging," Kane told Psychiatric Times. "Those patient randomly assigned to LB-102 experienced significant improvement on the PANSS total score between baseline and week 4."

You can read more about this data here.

Dr Kane is a professor of Psychiatry and Molecular Medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the codirector of the Institute for Behavioral Science at the Feinstein Institutes for Medical Research.