Additional Positive Data on LB-102 for the Treatment of Acutely Exacerbated Schizophrenia

LB Pharmaceuticals presented additional positive data from NOVA1, a phase 2 clinical trial of N-methyl amisulpride (LB-102) in patients with acutely exacerbated schizophrenia, at the 2025 Annual Congress of the Schizophrenia International Research Society (SIRS) being held in Chicago, Illinois, from March 29 to April 2, 2025. 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.

Initial data from NOVA were shared in early January; this presentation shares additional data from this trial. According to the data, 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 of LB-102. The study also measured mean change from baseline in Clinical Global Impression of Severity (CGI-S) score as a secondary endpoint. At week 4, 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); participants treated with the 75 mg dose (n=108) achieved a mean change in baseline CGI-S score of -0.67 compared with placebo (P =0.0048); participants treated 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 significant improvement in CGI-S scores observed in NOVA1 reinforces that LB-102 may provide a meaningful clinical impact on disease severity and further validates its strong potential as a next-generation treatment for schizophrenia,” said Heather Turner, chief executive officer of LB Pharmaceuticals. “These results support our vision for LB-102 as a therapy that provides a compelling balance of efficacy and safety, addressing the urgent need for better-tolerated, efficacious therapies for people with schizophrenia. As we advance toward the initiation of a phase 3 clinical trial in Q4 2025, this data strengthens our confidence in LB-102 as a first-in-class benzamide antipsychotic in the United States.”

Treatment with LB-102 was generally safe and well-tolerated. The most common adverse events were insomnia, headache, anxiety, and agitation, consistent with existing antipsychotics. Increases in prolactin were observed with few clinical adverse events associated with those increases. Some participants experienced modest weight gain, but it was not associated with a clinically meaningful signal in metabolic parameters.

“These CGI-S scores are compelling. In combination with the statistically significant change from baseline in the PANSS total scores, the findings of NOVA1 reflect the potential real-world clinical impact of LB-102 on patients with acute schizophrenia. While PANSS scores provide a structured measure of symptom changes, CGI-S offers an independent, clinician-driven, assessment of overall disease severity. The meaningful reductions in CGI-S scores suggest that study participants are experiencing not just statistical improvement, but tangible, clinically relevant benefits that could translate to better daily quality of life. Given the ongoing need for effective and well-tolerated treatment options, these findings further support the potential of LB-102 to help address a critical gap in schizophrenia care,” said John M. Kane, MD, professor of Psychiatry and Molecular Medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, the codirector of the Institute for Behavioral Science at the Feinstein Institutes for Medical Research, and the principal investigator of NOVA1.

You can watch an interview with Dr Kane on this new data here, exclusively with Psychiatric Times.²

References

1. LB Pharmaceuticals presents new data from phase 2 clinical trial of LB-102 at the 2025 Annual Congress of the Schizophrenia International Research Society. News release. March 31, 2025. https://www.globenewswire.com/news-release/2025/03/31/3052289/0/en/LB-Pharmaceuticals-Presents-New-Data-from-Phase-2-Clinical-Trial-of-LB-102-at-the-2025-Annual-Congress-of-the-Schizophrenia-International-Research-Society.html

2. Kane JM. LB-102 for the treatment of acutely exacerbated schizophrenia: insights from the principal investigator. Psychiatric Times. March 31, 2025. https://www.psychiatrictimes.com/view/lb-102-for-the-treatment-of-acutely-exacerbated-schizophrenia-insights-from-the-principal-investigator