Apimostinel is an antidepressant drug that improves synaptic plasticity. Credit: Pormezz / Shutterstock.

Gate Neurosciences and the University of Pittsburgh (Pitt) have commenced a Phase II clinical trial to evaluate the potential of extending the efficacy of the rapid-acting antidepressant drug apimostinel, when used alongside the university’s digital therapeutic.

Led by the university’s psychiatry, psychology, and clinical and translational science associate professor Dr Rebecca Price, the study aims to determine if combining the drug with the university’s digital neurocognitive training tool, Automated Self-Association Training (ASAT), can prolong its antidepressant effects.

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Gate Neurosciences president and CEO Mike McCully said: “Our precision drug candidates work by rapidly enhancing synaptic function and neuroplasticity, which has broad potential across mental health and cognitive disorders.

“This Phase II study partnership with Pitt gives us an exciting opportunity to potentially extend apimostinel’s treatment benefit in depressed patients with the ASAT platform, a synergistic and innovative digital tool.”

The ASAT programme conditions subjects to associate self-referential thoughts with positive attributes. This approach, when paired with apimostinel, is expected to leverage a ‘primed window of brain plasticity’, offering a more targeted method to sustain relief for individuals with depression.

Dr Price said: “We are thrilled to partner with Gate to further explore ASAT’s efficacy with apimostinel, and build on our previous success with extending ketamine’s benefit for depressed patients.

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“ASAT was crafted to complement rapid-acting treatments for psychiatric disorders. It is designed to be as efficient as possible, with short digital administrations, and shows promise for extending single-dose outcomes by months.”

Apimostinel and another Gate molecule, zelquistinel, share ketamine’s mechanism of enhancing neuroplasticity but with a better safety profile.

A second-generation intravenous N-methyl-D-aspartate (NMDA) receptor-positive allosteric modulator (PAM), apimostinel is claimed to have exhibited rapid and significant antidepressant effects lasting up to seven days in an earlier Phase II trial.

A recent Phase I biomarker study of the drug revealed positive quantitative electroencephalography (qEEG) biomarkers of NMDA target activation.