After a spring and summer of positive news (bullish analyst coverage, an uplisting to the NYSE, and a solid run of prices surges) Cybin has followed the rest of the psychedelic medicine market into a quiet spell and stock price pullback.
But this week the company returned to our news feeds with two solid announcements.
Cybin Announces FDA Authorization of New Feasibility Study Using Kernel Flow Technology
The company announced that the FDA has authorized an Investigational New Drug (“IND”) application to proceed with a feasibility study using Kernel’s Flow technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.
From the company’s press release:
“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. This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding,” said Dr. Alex Belser, Cybin’s Chief Clinical Officer.
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.
“Quantitatively measuring the brain within the context of a psychedelic experience is a promising frontier,” said Bryan Johnson, founder and Chief Executive Officer of Kernel. “With Kernel Flow, Cybin’s researchers can start putting numbers and quantification to subjective states of mind, including altered ones.”
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, Kernel Flow is easily wearable. 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 an 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.
Cybin Announces Launch of EMBARK Psychedelic Facilitator Training Program
Drug development is only one piece of the psychedelic puzzle. Therapy is the other. And delivering future treatments at scale will be one of the great logistical hurdles for the industry.
Which is why therapist training programs like the one Cybin just announced are un-flashy yet crucial bits of industry news.
From the company’s press release:
Led by a team of esteemed faculty, the program offers psychedelic clinical trial facilitators the foundational training needed to provide skillful and ethical care to participants receiving psychedelic treatment. With an emphasis on experiential learning, the training will kick off with an in-person training retreat at the Whidbey Institute, a home for transformational learning in Washington state. The training includes an experiential training component, in addition to the core training and practice sessions on the EMBARK model.
This fall cohort of EMBARK facilitators is a collaborative project with the University of Washington, and these facilitators are preparing for the first clinical trial exploring the potential of psilocybin-assisted psychotherapy to treat healthcare workers experiencing COVID-related distress. This clinical trial, co-sponsored by Cybin, will aim to treat symptoms of depression, anxiety, burnout and post-traumatic stress among frontline doctors, nurses, and healthcare professionals. The study’s Primary Investigator, Dr. Anthony Back, and Ladybird Morgan, RN, MSW, have contributed to an adapted version of the EMBARK therapy manual to address the unique needs of healthcare workers affected by the pandemic. The study will be hosted in Seattle, a city hit hard with an early coronavirus outbreak.
The training curriculum is based on EMBARK, a ground-breaking psychotherapy model that integrates leading clinical approaches to promote supportive healing with psychedelic medicine. EMBARK’s creators, Bill Brennan, PhD (cand.) and Alex Belser, PhD, Cybin’s Chief Clinical Officer, drew from process evidence in psychedelic clinical practice and the experience of senior teachers and supervisors. EMBARK is a transdiagnostic model that is adaptable to different clinical indications and challenges including depression, alcohol use disorder, and anxiety.
“We’re excited to host this training. When we first created EMBARK, we canvassed twenty different psychedelic-assisted psychotherapies. We found that some therapies left out important aspects, like people’s spiritual experiences, somatic experiences, or human relationships. Patients were telling us that these experiences were central to their healing, but many therapies seemed to be missing critical pieces. To address this challenge, we developed EMBARK, which provides an open architecture to support the varieties of psychedelic experience within a coherent therapeutic framework. This is a patient-centered approach for the whole person,” said Dr. Alex Belser, EMBARK’s co-author and Cybin’s Chief Clinical Officer.
EMBARK’s six clinical domains (Existential-Spiritual, Mindfulness, Body Aware, Affective-Cognitive, Relational, Keeping Momentum) represent the broad spectrum of ways in which therapeutic benefits may arise in psychedelic treatment and the equally broad training needed to prepare therapists to support them all. Training in EMBARK prepares facilitators to work within all of these domains, while inviting facilitators to bring in their own therapeutic training and expertise in a flexible, yet structured way. The EMBARK curriculum additionally emphasizes trauma-informed, culturally competent, and ethically rigorous care.
“Psychedelic medicines and the great healing potential they hold have only just begun to find their place in our culture and its array of therapeutic approaches. EMBARK represents an important step forward in that process. We designed it to be uniquely responsive to the distinctive and disruptive ways that these medicines heal people, while also able to incorporate synergistic aspects of other evidence-based treatments. Its flexible, six-domain structure allows us to open the aperture on our notions of healing and expand our ability to help patients reach a place of wellness. We offer EMBARK in a spirit of service and deep respect for psychedelic medicines and the many avenues of healing they open to us,” said Bill Brennan, PhD (cand.), EMBARK’s co-creator.
