Gate Neurosciences Announces Clinical Collaboration with Beacon Biosignals to Advance Precision EEG Biomarkers in Major Depressive Disorder

INDIANAPOLIS ~ Indianapolis - Gate Neurosciences, a clinical-stage biotechnology company, has announced a strategic collaboration with Beacon Biosignals to advance the use of electroencephalogram (EEG) biomarkers in their clinical pipeline for neuropsychiatry and cognition. This partnership will utilize Beacon Biosignals' FDA-cleared Dreem™ 3S headband device and neurobiomarker platform to conduct EEG and sleep analyses in patients with depression who are enrolled in Gate's upcoming Phase 2 trial of zelquistinel.

Zelquistinel is a once-weekly oral NMDA receptor positive modulator that is currently being developed for the treatment of major depressive disorder (MDD). The collaboration between Gate Neurosciences and Beacon Biosignals marks a new era of precision psychiatry, as they aim to use innovative biomarker insights, approaches, and technology to improve outcomes for patients with mental health, cognitive, and neurodevelopmental disorders.

Mike McCully, CEO of Gate Neurosciences, expressed excitement about the partnership, stating that they will apply data and key learnings from their combined experience in psychiatric clinical studies and EEG analyses to ultimately benefit patients. He also mentioned that this collaboration is the next phase of precision psychiatry for Gate, building on their existing biomarker research including EEG data from prior zelquistinel clinical studies.

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In November 2023, Gate announced positive results from a Phase 1 EEG biomarker study of apimostinel (a second-generation injectable NMDA receptor modulator), which showed consistent human EEG signatures representing NMDAR target activation. In the upcoming zelquistinel Phase 2 depression study, Gate will utilize Beacon's biomarker platform to gain deeper insights into patient diagnoses, treatment response, and target activation over six weeks of dosing.

Beacon Biosignals' CEO Jacob Donoghue highlighted the challenges in determining the best treatment pathway for patients with psychiatric disorders, as outcomes can vary widely within the same diagnosis. He believes that their collaboration with Gate will provide a level of precision understanding never before possible, thanks to the use of Beacon's at-home hardware and AI-powered software to measure brain activity during sleep.

Beacon Biosignals' analytics platform combines their large clinical EEG databases and proprietary machine-learning algorithms to identify neurobiomarkers that assist with patient stratification, assessing drug activity, and therapeutic efficacy. The platform's key component is the Dreem™ 3S EEG device, which is FDA-cleared and clinically validated. This wearable device measures sleep architecture and EEG activity in patients with central nervous system disorders and is designed for comfortable, longitudinal brain monitoring. The data collected by the Dreem™ 3S device will flow into Beacon Biosignals' analytics platform to provide validated neurophysiological endpoints for clinical trials.

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This collaboration between Gate Neurosciences and Beacon Biosignals represents a significant step forward in precision psychiatry and has the potential to greatly improve treatment outcomes for patients with mental health disorders. With their combined expertise and innovative technology, they aim to pave the way for more effective treatments in the future.
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