Cybin: FDA Authorizes Feasibility Study To Measure Ketamine's Effect On Cerebral Cortex

Cybin Inc. CYBN CYBN, a biotechnology company focused on progressing psychedelic therapeutics, announced Wednesday that the U.S. Food and Drug Administration (FDA) has authorized an Investigational New Drug application to proceed with the company’s sponsored feasibility study using Kernel’s Flow technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.

Leveraging Kernel’s quantitative neuroimaging technology (“Kernel Flow”) may lead to new frontiers in psychedelic therapeutics by enabling the acquisition of longitudinal brain activity before, during and after a psychedelic experience, providing quantification of what was previously subjective patient reporting.

“The word psychedelic means ‘mind-manifesting,’ but what has been missing is useful ‘mind-imaging’ (the ability to dynamically trace the neural correlates of human conscious experience). Conventional neuroimaging just isn’t dynamic enough to study the psychedelic experience in the brain as it happens,” said, Dr. Alex Belser, Cybin’s chief clinical officer in a Tuesday press release. 

“This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding,” added Belser.

Bryan Johnson, founder and CEO of Kernel noted that “quantitatively measuring the brain within the context of a psychedelic experience is a promising frontier. With Kernel Flow, Cybin's researchers can start putting numbers and quantification to subjective states of mind, including altered ones.”

"Kernel Flow"

Kernel Flow uses pulsed light instead of continuous-wave light to increase measured brain information. In contrast with electroencephalography (“EEG”) electrodes that usually require gel on the head or functional magnetic resonance imaging (“fMRI”) studies that require a participant to lie in a scanner.

The entire system is the size and look of a bicycle helmet and could, in the future, be more broadly used for neuroscientific or physiological studies of brain activity during psychedelic use.

As part of Cybin’s sponsorship of the feasibility study, the company will retain exclusive interest in any innovations that are discovered or developed through its independent analysis of the study findings. Kernel will hold the same rights relating to its Kernel technology.

"We hope this feasibility study can bridge the gap of real-time quantitative data collection during psychedelic treatments to further understand the correlation of effects from these powerful molecules. The ability to access real-time brain activity data during a psychedelic experience has tremendous potential for the development of future psychedelic therapeutics," stated Doug Drysdale, CEO of Cybin.

Photo by CDC from Pexels