The first subject has been dosed in a Phase I biomarker study of apimostinel, a rapid-acting N-methyl-D-aspartate receptor (NMDAR) modulator for major depressive disorders (MDD).
The injectable treatment was developed by clinical-stage biotechnology company Gate Neurosciences for acute depressive disorders such as postpartum and episodic depression, and depression with suicidality.
Apimostinel previously demonstrated proof-of-concept in a Phase IIa MDD study. The ongoing biomarker study aims to further the understanding of dose dynamics using various electroencephalogram (EEG) measures after single and multiple ascending doses in 40 healthy subjects.
The study also aims to confirm NMDA receptor target engagement and evaluate measures of cognitive processing and synaptic function using event-related potentials (ERP) such as mismatch negativity and P300 latency. Topline readout from the study is expected in the first half of 2023.
“The ongoing apimostinel biomarker study enables us to further define optimal dose levels and intervals and de-risk a next apimostinel Phase IIb confirmatory efficacy study,” said Dr Anantha Shekhar, Chief Scientific Officer at Gate Neurosciences and Dean of the University of Pittsburgh School of Medicine.
In a previously completed Phase IIa study, a single dose of apimostinel showed statistically significant antidepressant effects at 24 hours and no ketamine-like dissociative or psychotomimetic side effects.
Gate Neurosciences plans to use results from the EEG biomarker study to further de-risk dose selection in a confirmatory Phase IIb efficacy study of apimostinel planned for mid-2023.