Gate Neurosciences, in collaboration with the University of Pittsburgh (Pitt), has commenced a Phase II clinical trial to investigate the potential of apimostinel, a rapid-acting antidepressant drug, in extending its efficacy when used in conjunction with Pitt’s digital therapeutic, Automated Self-Association Training (ASAT). This study aims to provide a more sustained relief for individuals suffering from depression by leveraging a 'primed window of brain plasticity'.
Study Design and Objectives
Dr. Rebecca Price, Associate Professor of Psychiatry, Psychology, and Clinical and Translational Science at the University of Pittsburgh, leads the study. The primary objective is to determine whether combining apimostinel with ASAT can prolong the antidepressant effects observed with apimostinel alone. ASAT is a digital neurocognitive training tool designed to condition subjects to associate self-referential thoughts with positive attributes.
Apimostinel: Mechanism and Prior Data
Apimostinel is a second-generation intravenous N-methyl-D-aspartate (NMDA) receptor-positive allosteric modulator (PAM). It enhances neuroplasticity, similar to ketamine, but with an improved safety profile. Previous Phase II trials have indicated that apimostinel exhibits rapid and significant antidepressant effects, lasting up to seven days. A recent Phase I biomarker study also revealed positive quantitative electroencephalography (qEEG) biomarkers indicative of NMDA target activation.
Synergistic Approach
The combination of apimostinel and ASAT is designed to be synergistic. Apimostinel rapidly enhances synaptic function and neuroplasticity, while ASAT aims to reinforce positive self-associations, potentially extending the duration of antidepressant effects. Mike McCully, President and CEO of Gate Neurosciences, stated that this partnership with Pitt offers an exciting opportunity to extend apimostinel’s treatment benefit in depressed patients using the innovative ASAT platform.
ASAT's Role in Extending Treatment Benefits
Dr. Price highlighted the potential of ASAT to complement rapid-acting treatments for psychiatric disorders. ASAT is designed for efficient, short digital administrations and has shown promise in extending single-dose outcomes by months, building on previous success in extending ketamine’s benefit for depressed patients.
