Asking a patient to describe how they are feeling gives psychiatrists and therapists helpful but subjective information about what’s going on inside a person’s mind. By comparison, cardiologists have a variety of diagnostic tools that allow them to check blood pressure or perform electrocardiograms to check for heart conditions. But researchers developing psychedelic-assisted therapies are now beginning to use advanced technology to gather more precise data about brain functions that could help them develop a new generation of compounds.
Toronto-based biotechnology company Cybin Inc. announced last month that it was partnering with Kernel, a Los Angeles-based company that is innovating neuroimaging for drug development. Cybin, which is developing psilocybin-based treatments for psychiatric illness, will use Kernel’s Flow technology to conduct studies that aim to quantify the psychedelic experience in real time and inform the development of future therapies.
It’s not that good neuroimaging technology doesn’t already exist, says Doug Drysdale, CEO of Cybin. It’s just that the technology can cost millions of dollars to operate and take up an entire room, making it expensive and time consuming to use with patients on a regular basis.
“That’s not very practical,” Drysdale said. “What [Kernel] has done is miniaturized this technology and made it very precise.”
Kernel says that it can document patterns of brain activity through Flow, a headset which resembles the marriage between a bicycle helmet and a fractured egg shell. Flow beams light through the skin into the skull, then measures its scattering and absorption in the brain through sensors positioned around the headset. This allows the device to record brain activity in real time, albeit on a smaller and more intimate scale than an MRI. Kernel says the technology is safe, non-invasive and costs only a few thousand dollars to manufacture.
“That enables us to take that room-sized technology and apply it to patients,” says Drysdale.
According to Drysdale, Cybin intends to start performing studies with Flow in the second half of 2021. Studies will focus on observing brain function before, during and after treatments with psychedelic compounds, with research potentially targeting depression, addiction, cognitive impairment and ADHD.
“The primary aim is to turn what was once qualitative into quantitative data that can be used to expand our understanding and potentially support future drug development,” says Drysdale.
Cybin hopes that these research findings will help develop treatments that are scalable and accessible for patients, physicians and providers. “It’s very much a learning process at this stage,” says Drysdale. “The first step will be to establish some baseline datasets against which to compare various dosing and therapeutic scenarios.” Once a baseline is established, studies can start to look at other factors, he adds.
Future studies can also monitor changes in the brain over longer and more precise periods, to see if alterations from psychedelic treatments are one-offs, or form long lasting modifications in the brain, says Drysdale.
Drysdale says Cybin will also use the Flow data to optimize the onset time of treatment and reduce the amount of time patients need to be observed by therapists. “It’s a burden on the system, and we’re trying to remove some of the time and duration of the treatment, and the therapist resource time,” says Drysdale.
Since most past studies have looked at larger doses of psychedelic molecules, another drug development pathway that Flow could open up is the effect of lower doses, says Drysdale.
“Where it starts to get interesting to me is when you move to sub-perceptible doses, where the response the patient is feeling might be small and difficult to capture,” says Drysdale. “We’re hopeful that the Flow device will help us get a lot more insight there.”
A Partnership Between Psychedelics and Technology
According to both companies, the partnership between Cybin and Kernel is based on a shared mission. Bryan Johnson, founder and CEO of Kernel, says he has always been interested in the potential of psychedelics to alter the human condition for the better.
“It opens up opportunities for how we might improve ourselves and society in general,” says Johnson.
Johnson founded Kernel in part with capital from the sale of his previous venture, the web and mobile payments company Braintree. After Braintree acquired Venmo, Johnson sold the company to eBay in 2013 before switching gears.
“I was trying to find something that would be useful to the world,” says Johnson. “Most of our technology today is, by default, in service of the tech provider, not to enable the person to be better.”
Johnson saw personalizing the emergent science of quantifying brain function as a way to achieve that improvement. “We don’t have numbers for our brains and our minds,” he says.
Kernel has already performed some in-house studies on brain function including one investigation into sleep and cognition. The study serves as an example of the scope and flexibility the Flow device might offer researchers. The study followed 12 subjects—including Johnson—over six weeks. Participants wore Flow devices three times a week for 60 minutes at a time. For Johnson, one of the most interesting findings was the connection between his own willpower, as measured by an “impulse control task” and how much deep sleep the Flow device recorded him receiving.
Johnson says his aspiration is to see every house equipped with a Flow device by 2030, but for 2021, he’s putting it in the hands of commercial and academic partners for their own research purposes. “We have our program titled Kernel Flow 50,” says Johnson. “Fifty devices in the hands of partners. This fall, we will begin shipping our production.”
Cybin, which also plans to receive Flow this fall, plans to use three of those devices in parallel.
Cybin is Kernel’s first announced commercial partnership, says Johnson. Other partners include Harvard and Boston University, whose studies with Flow will focus on gathering data on a wide range of mental conditions and functions, from concussions, traumatic brain injuries, stroke and brain aging, to meditation, lucid dreaming and human social interactions.
“It opens up an entire new horizon of science,” says Johnson. “Once you have the science, it leads to engineering. Custom molecules. Custom doses. You would have precise recommendations.”
“I think Cybin recognizes the potential improvement that quantification of brain function can offer,” he added. “If our devices can indeed provide insights by quantification, it allows them to make better therapies, safer, more personalized.”
Cybin Expands Collection of Data and IP
According to Drysdale, Cybin is anticipating a busy 2021 with plans to expand its portfolio of intellectual property.
Cybin closed 2020 by acquiring Adelia Therapeutics, a biopharmaceutical company that has published more than 300 peer reviewed papers and holds more than 85 patents, says Drysdale. “That brings substantial preclinical bench strength,” he said. “Before the acquisition, we were very much a clinical company.”
Cybin currently holds 10 patents covering therapeutic molecules and delivery systems. The company is currently undertaking a clinical study of sublingual psilocybin for the treatment of major depressive disorder. “We continue to add to that on a monthly basis,” says Drysdale of the company’s patent portfolio. “We expect to see further expansions of our filings.”
Cybin’s psilocybin study is being done in partnership with the University of West Indies and will focus on determining optimal dosage to improve treatment. In most methods of delivery, about half of the psilocybin can be lost, says Drysdale.
“It’s a 2A and 2B study,”says Drysdale. “Because we want a faster onset of action, we don’t know what precisely the equivalent dose will be. That’s the first part of the study. That’ll be 40 patients in total. Once we’ve selected the dose, we move into the 2B, safety and efficacy.”
The second half of Cybin’s psilocybin study is anticipated to start around the middle of this year, says Drysdale. He says the company should see a tripling of patient sample size and expand into additional research sites in Canada and the United States.
Drysdale cites a study conducted last year at John Hopkins University that shows a combination of psilocybin treatments and psychotherapy produces rapid and lasting reduction in depression. A month after treatment, 71-percent of study participants showed the same decrease in symptoms of depression. Drysdale notes that these findings are significant when compared to SSRIs like Prozac, which he says are no better than placebo in the long term .
“If that effect will last for several months, this is a whole different paradigm for treating depression,” says Drysdale.
Cybin’s research and development plan has attracted an influx in capital since the company went public last year. In November 2020, Cybin completed a reverse takeover, of Canadian mining company Clarmin Explorations Inc. – a strategy for quickly going public in which a private company purchases controlling interest of a publicly traded company.
The go-public financing round raised gross proceeds of CAD$45 million ($35.2 million US), a record breaking figure in the Canadian psychedelics sector.
Cybin began trading on the NEO, a Toronto-based Canadian stock exchange, five days later. In its first month as a public company, Cybin stock was trading for around 75 cents a share, Drysdale says. Now, it’s consistently trading above CAD$2.
On February 4, Cybin announced it had closed an upsized offering deal, issuing more than 15 million shares to raise more than CAD$34.3 million in additional funding.
“It’s not just about the share price,” says Drysdale. “We’re fortunate to have a wide range of blue chip US funds invest in us.”
According to Drysdale, current investors include RA Capital Management, Janus Hendersen Investors and LifeSci Venture Partners.
To date, Drysdale says Cybin has raised approximately CAD$88.8 million and plans to allocate about CAD$2 million for the Flow study.