Phase 1 Study of Apimostinel for Depression Doses First Participants

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A Phase 1 biomarker and multiple ascending dose study of apimostinel for the treatment of depression has dosed its first cohort of participants.

Apimostinel is a second-generation, rapid-acting, injectable N-methyl-D-aspartate receptor (NMDAR) modulator program in development by Gate Neurosciences for the treatment of acute depressive disorders and depression with suicidality. Phase 1 dosing follows a previous Phase 2a major depressive disorder (MDD) study, wherein 1 dose of apimostinel demonstrated rapid, statistically significant antidepressant effects after 24 hours (p=0.0034) and a safe, well-tolerated profile with no psychotomimetic or dissociative adverse effects.¹

Overall, the ongoing apimostinel study aims to enhance understanding of dose dynamics with the use of electroencephalogram (EEG) measures after giving 40 healthy participants single and multiple ascending doses.¹

“The ongoing apimostinel biomarker study enables us to further define optimal dose levels and intervals and de-risk a next apimostinel Phase 2b confirmatory efficacy study,” said Dr. Anantha Shekhar, MD, PhD, chief scientific officer at Gate Neurosciences and dean of the University of Pittsburgh School of Medicine, in a press release. “Understanding dose dynamics is central to this emerging treatment paradigm in neuropsychiatry where rapid and durable changes in synaptic function are achieved with single doses of our NMDAR modulators.”

Gate Neurosciences has announced that it plans to use the EEG biomarker study results to de-risk dose selection in a Phase 2b efficacy study, which will be initiated in mid-2023.¹

“Apimostinel is an acute injectable procedure that is complementary to our lead oral candidate, zelquistinel, and this paradigm could completely transform how depressive disorders are managed,” concluded Mike McCully, president and CEO of Gate Neurosciences, in a press release. “Apimostinel offers an opportunity for physicians to administer a safe rapid-acting antidepressant to patients onsite, providing advantages for both patients and physician practices alike.”

Reference

1. Gate Neurosciences doses first subject in a translational EEG biomarker study of apimostinel, a rapid-acting treatment for acute depressive disorders. News release. Business Wire. November 29, 2022. Accessed November 30, 2022. https://www.businesswire.com/news/home/20221129005198/en/Gate-Neurosciences-Doses-First-Subject-in-a-Translational-EEG-Biomarker-Study-of-Apimostinel-a-Rapid-Acting-Treatment-for-Acute-Depressive-Disorders