Phase I clinical trial validates qEEG biomarker in CNS disorders


Gate Neurosciences has announced positive topline quantitative EEG (qEEG) biomarker and safety results from its Phase I multiple ascending dose study of apimostinel in healthy volunteers.

The results demonstrated a dose-dependent increase in qEEG pharmacodynamic biomarkers of NMDA receptor target activation from baseline, compared with subjects who received placebo.

Maximal qEEG effects were observed at dose levels consistent with antidepressant efficacy observed in a prior Phase IIa proof of concept (POC) study of apimostinel, validating the biomarker for informing dose selection in future clinical efficacy studies across the class of molecules.

Apimostinel was also generally well-tolerated with no ketamine-like dissociative side effects, highlighting its novel mechanistic approach of enhancing synaptic function.

The positive human qEEG biomarker results with apimostinel are consistent with prior biomarker observations with zelquistinel, Gate’s lead programme, which is currently being developed as a rapid-acting, once weekly, oral treatment for major depressive disorder (MDD).

“We are very excited to see a consistent, objective biomarker of receptor activation across two independent clinical programmes in both apimostinel and zelquistinel. These new positive qEEG results further advance our confidence in dose selection and our understanding of how this novel class of molecules achieves rapid and durable effects through event-driven pharmacology,” said Mike McCully, CEO of Gate Neurosciences. “We now have even more conviction in our upcoming Phase II depression study of zelquistinel, our lead rapid-acting oral programme.”

Apimostinel is a rapid-acting injectable programme behind the company’s lead oral small molecule zelquistinel, both of which are novel positive modulators of the NMDA receptor designed to enhance synaptic function in patients with mood and cognitive disorders.

Gate plans to initiate a Phase II study of zelquistinel to confirm efficacy in MDD in Q1 2024.

Read DDW’s interview with Mike McCully, CEO of Gate Neurosciences.

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