Schizophrenia is a mental disorder affecting nearly three million people in the US. Credit: Raman Oza from Pixabay.

US-based biotechnology company LB Pharmaceuticals has started the dosing of LB-102, a benzamide formulation intended for the treatment of patients suffering from schizophrenia, in a Phase I trial.

LB-102 is meant to serve as an improved version of amisulpride, which is used in Europe but is not available in the US.

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Amisulpride is used to treat schizophrenia in approximately 50 countries, as well as the EU.

LB-102 is designed to imitate the biding affinity of amisulpride to the D2/D3 and 5HT7 receptors and improve brain permeability. In-vitro testing showed that the drug candidate has a strong affinity for the D2/D3 receptors and some affinity for the 5HT7 receptor.

In-vitro, the drug candidate was better able to cross a neutral membrane compared to amisulpride. The efficacy of LB-102 was comparable or superior to amisulpride in three in-vivo schizophrenia models.

LB Pharmaceuticals president and CEO Zachary Prensky said: “The preclinical activity profile of LB-102 suggests that it has the potential to build upon the excellent efficacy and safety profile observed in the clinical use of amisulpride for over 20 years.

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“We believe that, if approved, LB-102 would make for a useful addition to the toolbox of treatments available to psychiatrists for the treatment of schizophrenia.”

Nearly three million people in the US are impacted by schizophrenia and many patients experience modest efficacy and significant side effects with existing antipsychotics.

Last month, Sunovion Pharmaceuticals reported positive results from the SEP361-202 open-label extension study of SEP-363856 in schizophrenia. SEP-363856 is a trace amine-associated receptor 1 (TAAR1) and serotonin 1A (5-HT1A) receptors agonist discovered in partnership with PsychoGenics.

The open-label extension study evaluated the long-term safety and effectiveness of the drug over 26 weeks in 157 patients who completed a four-week, double-blind treatment phase.