Partnership to advance EEG biomarkers, tech to be used in pending phase 2 MDD study

Key takeaways:

• The trial will include a headband device and neurobiomarker platform to conduct EEG and sleep analyses in those with major depressive disorder.
• The trial is scheduled to begin later this year.

A biotechnology company has announced a partnership with a precision biomedicine firm to advance the use of electroencephalogram biomarkers across its clinical pipeline in neuropsychiatry and cognition.

According to a press release from Gate Neurosciences, its collaboration with Beacon Biosignals will first involve utilization of Beacon’s FDA-cleared Dreem 3S headband device and neurobiomarker platform to conduct exploratory EEG and sleep analyses in those with major depressive disorder enrolled in Gate’s pending phase 2 trial of zelquistinel, slated to initiate by the middle of this year.

Zelquistinel is a rapid-acting, once-weekly oral N-methyl-D-aspartate (NMDA) receptor positive modulator in development for treating MDD.

“The Gate team is excited to partner with Beacon in pioneering a new era of precision

psychiatry with innovative biomarker insights, approaches and technology,” Gate Neurosciences CEO Mike McCully said in the release.

Announcement of the partnership comes 2 months after Gate revealed positive results from a phase 1 EEG biomarker study of apimostinel, a second-generation injectable NMDA receptor modulator, which demonstrated a consistent, dose-dependent human EEG signature representing NMDA receptor target activation, the company said in the release.

Gate is expected to employ Beacon’s biomarker platform in the phase 2 trial to gain insight into patient diagnoses, treatment response and target activation over the 6-week dosing interval. The platform, which includes the wearable Dreem 3S headband, combines large clinical EEG databases and proprietary machine-learning algorithms to identify neurobiomarkers that assist with patient stratification, assessing drug activity and therapeutic efficacy, per the release.

“In psychiatry, outcomes can vary widely within the same diagnosis, making it difficult for patients, families and providers to determine the best treatment pathway for any individual,” Beacon Biosignals CEO Jacob Donoghue, MD, PhD, said in the release. “We look forward to working with the team at Gate on the upcoming clinical trial for zelquistinel and to making further progress on this cutting-edge research.”