Real-time quantification of brain activity during the psychedelic experience has been a major barrier within psychedelic research. A unique partnership between Cybin and Kernel aims to tackle this problem using a near-infrared spectroscopy system.
Life sciences company Cybin, which is taking classical psychedelic drugs and transforming them into scalable therapeutics for mental health disorders such as depression, anxiety, and addiction, has teamed up with neurotech company, Kernel, to harness its innovative technology to gather longitudinal brain activity data before, during and after a psychedelic experience.
Kernel Flow is the first commercially scalable time-domain functional, near-infrared spectroscopy system that enables the quantification of what was previously subjective self-reporting, says Doung Drysdale, CEO at Cybin.
“There is currently some neuroimaging data around psychedelics from Imperial College, London. Robin Carhartt-Harris has been using fMRI, to look at brain activity during the psychedelic treatment but that is quite difficult to do. fMRI machines are expensive and they are hard to access. From a practical point of view, putting someone in a metal tube with 120 decibels while they are on a psychedelic drug doesn’t sound great.
“The Kernel team has done something really quite spectacular. They have taken near-infrared spectroscopy, which has been around for quite a while, however, they have managed to miniaturise it. They have created far more intense lasers and are pulsing the light with full head coverage, and then measuring the scatter that comes back from what it hits, whether that is cranium, or tissue or a blood vessel, for example.
“Because it is pulsed to get real-time data from the cranium, that means we should be in a position to collect far more data because this helmet should be a lot more accessible.
“We are hoping to see real-time brain activity data before, during and after a psychedelic treatment. Maybe we will be able to see neuroplasticity that we have seen under fMRI, and we might be able to see how long that persists after dosing because it will be a easier to keep the patients under the neuroimaging device. We may see specific areas of the brain light up, which may help us create more targeted treatments in the future. But we are at the early stages with the device.”
Cybin is running a study with Kernel using ketamine, which is expected to complete before the end of this year, and which Drysdale says will help guide how to use the device with psychedelics in the future.
“With this device I think it is inevitable that we will learn more. When you think about the scarcity of neuroimaging data with psychedelics, because of lack of access to technology, then we are bound to. What we don’t know yet with the device is exactly what we will see, what kind of detail. But I’m optimistic – I think being able to finally have a quantitative tool when investigating these drugs is going to be really valuable.
“With many kinds of clinical trials, whether it’s pain or depression, for example, often the patients are just getting a questionnaire which doesn’t really replace the quantitative data that we hope to get from the Kernel device.”
Drysdale highlights the device could also help to understand the efficacy of microdosing, for which there is currently very limited evidence to show whether or not it is beneficial for conditions such as treatment-resistant depression.
“When you think about doses that are the sub-hallucinogenic, where there is a barely perceptible effect, perhaps in attention deficit or cognitive impairment, we have seen a lot of anecdotal data around microdosing that it can be beneficial. However, no one has really proven that – there have not been any robust large-scale clinical studies, because those kinds of studies are hard to do when you have got a very small effect size.
“It’s hard to measure as you need that large sample size with lots of patients. So, it is possible that the device might help us detect and quantify activity with these sorts of treatments or with very low doses that might lead to future treatments in these kinds of indications.
“There is still a stigma around these molecules from decades of the war on drugs and regulators like data. So, if we have data we have pictures that show, quantify or help us understand in more detail what kind of activity is really going on in the brain during these treatments then it just goes to further support the science.
“We know what receptors these molecules bind to and we believe that there is this period of neuroplasticity that occurs during psychedelic treatment, but we really do not know how those two things are connected. We do not really know why this neuroplasticity occurs, or how it occurs, or what mechanism drives it. You can have drugs that hit the 5-HT2A receptor, but do not give you neuroplasticity, so, maybe we can start to understand the connection between those events.”
Cybin is carrying out a number of studies exploring anxiety, depression and alcohol use disorder and is currently waiting for regulatory approval for a further study with the University of Washington, Seattle, exploring the use of psilocybin as a treatment for PTSD from COVID-19 in frontline healthcare workers.
“When we look at classical psychedelic molecules, we know an awful lot about them, and we know a lot about their metabolism, toxicology, the chemistry – that is a great starting point for drug development. But many of these molecules have challenges that make them really quite difficult to use in their classic form as therapeutics,” says Drysdale.
“Firstly, is bioavailability – DMT has almost no oral bioavailability, and psilocybin has quite low bioavailability, maybe 40 per cent, and that is very variable. Another challenge is that they are quite long lasting. So, a psilocybin session might be six hours, an LSD session might be as much as eight hours, and with MDMA, patients might have to stay overnight, maybe can’t even drive the next day, technically. So, those don’t really provide opportunities for scalable treatments – it is hard to see how depression clinics or addiction clinics can really adapt these treatments on a large scale.
“Our goal is to use medicinal chemistry and drug delivery technologies to modify these classical psychedelic drugs, retain their efficacy and retain their receptor-binding properties, to create treatments that have a faster onset of action, or have a shorter duration, that might fit within a typical kind of therapy window of 45 minutes to two hours.”
Cybin is focusing on improving the bioavailability of psilocybin through the development of a sublingual formulation that will be explored as a treatment for major depressive disorder, aiming to achieve rapid onset of action by avoiding the GI tract and liver.
“Our programmes for alcohol use disorder and anxiety disorders are using a similar approach, however, rather than taking a long-acting molecule like psilocybin and trying to make it shorter, we are starting these two programmes with very short-acting tryptamines that would typically last maybe only ten minutes, and slowing the breakdown of those tryptamines in the body to make them last longer.
“Instead of a rocket spike plasma concentration, we expect to see more of a flatter curve, keeping the drug levels in the therapeutic window, but removing the spike that causes side effects, and extending the duration.
“Our anxiety programme is based on a molecule that has almost no oral bioavailability at all, so, we’ll be combining that with an inhalation technology so we can deliver the drug directly through the lungs, and right into the bloodstream very effectively. Again, bypassing the liver and the GI tract.”
Psychedelic therapy programmes launch to address heartbreak, burnout and more
Mindbloom has launched its new Mastermind Series of psychedelic programmes for overcoming heartbreak, burnout and other unique mental health challenges.
Led by and developed with leading experts in the field, each programme combines specialised teachings with ketamine therapy.
All programmes will include six ketamine therapy sessions focusing on a specific mental health issue, expert-led audio, video, and written content for preparation, treatment, and integration, practical tools such as meditation, one-on-one coaching and group integration sessions.
The first programme in the Series is ‘Recovering from Rejection and Failure’, led by Dr Guy Winch who is a leading authority on emotional health, and a best-selling author and TED speaker whose talks have received over 30 million views.
Winch’s programme focuses on healing and preventing emotional injuries that people suffer in their personal, professional and romantic lives.
Mindbloom CEO and Founder Dylan Beynon stated: “More than 100 studies and 20 plus years of clinical use show that ketamine therapy may be the most transformational mental health treatment available today.
“In the face of epidemics of mental illness, addiction, and loneliness, we’re thrilled to offer our clients access to top experts across a range of issues – and to pair their expertise with our best-in-class ketamine therapy honed over hundreds of thousands of treatment sessions.”
“Emotional wounds like rejection and failure can be even more devastating than physical wounds, yet we don’t give them the same time and attention,” added Dr Winch.
“I’m thrilled to combine my techniques for emotional first aid with ketamine therapy, which has been shown to increase neuroplasticity and help build emotional resilience.”
“Americans are struggling with heartbreak, burnout, and other challenges every day, and they’re looking for new tools to address them,” said Mindbloom’s Medical Director Dr Leonardo Vando.
“I’m grateful to these experts for providing Mindbloom’s clients with the unique practices and insights they’ve cultivated during their distinguished careers, to help them overcome the biggest obstacles in their lives.”
Psilocybin analogue shows positive results in Phase 2 depression study
Cybin has announced positive Phase 2 topline safety and efficacy data for its proprietary deuterated psilocybin analogue – CYB003 – for the treatment of major depressive disorder (MDD).
Results from Cybin’s study have shown that 79% of patients were in remission from depression at six weeks after receiving two doses of CYB003.
CYB003 demonstrated a large improvement in symptoms after one dose and a total of 79% of patients were responsive to the treatment. The compound also demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to moderate and self–limiting.
Additionally, Cybin has stated that the magnitude of improvement was superior compared to approved antidepressants and recently reported data with other psychedelics, stating that the effects translate into an unprecedented effect size.
The company has said that the results compare favorably to pooled data from 232 industry studies of current standard-of-care antidepressants, SSRIs, submitted to the FDA.
The announcement follows Phase 2 interim results in early November 2023, which demonstrated that CYB003 saw a “rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo”.
Cybin CEO, Doug Drysdale, stated: “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.
“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month.”
Drysdale emphasised that the strength of the data will support CYB003 into Phase 3 of the study.
Cybin CMO, Amir Inamdar, added: “The significant reduction in depression symptoms observed in our Phase 2 study is highly gratifying.
“At the three-week primary efficacy endpoint, a single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS.
“This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo.
“These effects were evident on day one with the 16mg dose and were also highly statistically significant. When data from 12mg and 16mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12mg).
“With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”
Cybin is planning on submitting topline data to the FDA with an aim to hold a Phase 2 meeting in Q1 of 2024, with further 12-week durability data from Phase 2 CYB003 expected in Q1, and recruitment for the Phase 3 study anticipated to begin by the end of Q1 2024.
Mychedelica launches to revolutionise psychedelic medicine
A new company specialising in psychedelic medicine – mychedelica – is offering a comprehensive suite of services to support the advancement of this transformative field.
With a team of experienced medical writers and research support specialists, mychedelica is committed to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in the psychedelic medicine space.
Psychedelic medicine is rapidly gaining recognition for its potential to treat a wide range of mental health conditions, including depression, anxiety, addiction, and post-traumatic stress disorder (PTSD). However, the field is still in its early stages of development, and there is a critical need for high-quality medical writing and research support services to facilitate its progress.
CEO of mychedelica, Bilal Bham, commented: “We are thrilled to launch mychedelica and contribute to the advancement of psychedelic medicine.
“Our team of experienced professionals is dedicated to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in this groundbreaking field.”
mychedelica provides a comprehensive range of services, including:
Medical writing: Experienced medical writers will craft clinical trial protocols, regulatory submissions, and peer-reviewed publications, ensuring that research findings are communicated clearly and effectively.
Funding research support: Experts in grant writing and fundraising strategies will assist researchers in securing funding for their psychedelic medicine studies.
Regulatory consulting: mychedelica’s team of regulatory experts will navigate the complex regulatory landscape surrounding psychedelic medicine, ensuring that clinical trials and products comply with all applicable laws and regulations.
With its commitment to quality and innovation, mychedelica is poised to play a pivotal role in shaping the future of psychedelic medicine. The company’s services will empower researchers to conduct rigorous clinical trials, clinicians to provide effective treatments, and pharmaceutical companies to develop safe and effective psychedelic medicines.
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