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Cybin aims to quantify brain activity during the psychedelic experience 

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Cybin aims to quantify brain activity during the psychedelic experience 

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.”

See also  First-of-its-kind research collaboration to investigate MDMA for TBI injury

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.”

Measuring microdosing

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.

See also  Europe to host Phase I DMT clinical trial

“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’s investigations

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. 

See also  New programme to explore R(-)-MDMA for autism and social anxiety

“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.”

 

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Top UK and European academics join Clerkenwell Health advisory board

Renowned academics in the field of psychedelics from leading European universities will be joining clinical research organisation Clerkenwell Health.

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Top UK and European academics join Clerkenwell Health advisory board

Clerkenwell Health is expanding its pan-European advisory board with the addition of Dr David Erritzoe, Dr Dea Siggaard Stenbæk, Dr Kim Kuypers and Dr James Stone from Danish, Dutch and British universities.

With psychedelic research flourishing in Europe, Clerkenwell Health says it is building connections between commercial research organisations and academic institutions. 

The expansion of its advisory board will give the company access to knowledge and networks from some of the most prestigious European universities – working to fulfil the company’s mission to create a more vibrant psychedelic clinical trial ecosystem and foster wider sharing of best practices across Europe.

Discover how Clerkenwell Health is developing a gold standard for psychedelic care

Chaired by Dr Henry Fisher, the Clerkenwell Health CSO, the board will focus on clinical research and therapy, with its new members bringing expertise in areas of psychotherapy, psychopharmacology, mental health, experimental medicine and psychedelics.

Speaking to Psychedelic Health, CEO of Clerkenwell Health, Tom McDonald, said: “The UK is an attractive location to undertake psychedelic drug development as the government are opening up innovation pathways and championing clinical research.

“We are excited to be joined in our work exploring psychedelics-assisted therapy here in the UK with leading experts from prestigious European universities. Their involvement ensures we have a variety of expert opinions to shape innovative trial designs whilst preparing a platform for European expansion in the coming years.”

See also  Clerkenwell Health is launching a free UK psychedelic therapist training programme

With an aim to support the commercial research ecosystem in the UK and Europe, the new board additions place Clerkenwell Health as an ideal partner to support drug developers wishing to conduct trials in European countries.

CSO of Clerkenwell Health, Dr Henry Fisher, stated: “I am delighted to be able to bring together such high calibre advisors into the Clerkenwell Health scientific advisory board. These researchers are leaders in their respective fields in Europe and are shaping the direction of clinical and fundamental research with psychedelics. 

“This gives us access to the knowledge and network built in some of the most prestigious universities from Copenhagen to Maastricht and London, and it is a privilege to be able to consult with these figures on our own research.”

Meet the advisory board

Dr David Erritzoe is clinical director and deputy head of the Centre for Psychedelic Research at Imperial College London.

Erritzoe is currently investigating brain mechanisms and therapeutic potential of MDMA, ketamine and classic psychedelics, and is clinical senior lecturer in general psychiatry in Centres for Neuropsychopharmacology and Psychedelic Research at Imperial, as well as consultant psychiatrist at St Charles Hospital, CNWL Mental Health NHS Foundation Trust. Erritzoe also heads a NHS-based research clinic at St Charles Hospital, the CIPPRes Clinic.

Dr Dea Siggaard Stenbæk is an associate professor at University of Copenhagen and Copenhagen University Hospital. 

Stenbæk’s research mainly focuses on neuropsychopharmacological effects of the 5-HT2A receptor agonist psilocybin. She collaborates with the Centre for Psychedelic Research at Imperial College London and is currently an honorary clinical research fellow in this group. As the clinical lead, she works on a study of psilocybin as a treatment for obsessive compulsive disorder.

Dr Kim Kuypers is an associate professor at Maastricht University. Her PhD focused on memory and risk-taking during MDMA intoxication. 

Kuypers’ main goal is to understand the neurobiology underlying flexible cognition, empathy and wellbeing. To accomplish this she uses a psychopharmacological model, studying the (sub)acute and longer-lasting effects of psychedelics on these behaviours and their underlying biology.

Dr James Stone worked as a clinical senior lecturer at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, with a focus on experimental medicine and clinical trials. 

During his time there, Stone set up the ketamine clinic at the Maudsley Hospital for patients with treatment-resistant depression. He also worked at Imperial College London as a senior lecturer, working as co-director of the intercalated BSc in neuroscience as well as continuing research into the role of glutamatergic abnormalities in psychosis.

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Psychedelics for addiction research gets $2.7m grant

The grant will fund research to investigate the efficacy of psychedelics for treating a variety of addiction disorders.

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Psychedelics for addiction research gets $2.7m grant

The University of California, Davis (UC Davis) and the University of Colorado Anschutz Medical Campus have received a $2.7m (~£2.15m) grant from the National Institute on Drug Abuse, part of the National Institutes of Health, to research psychedelics.

The researchers will use the funding to screen hundreds of compounds to discover new, non-hallucinogenic treatments for substance use disorders. 

With previous research having shown that psychedelic drugs can rewire parts of the brain involved in depression, substance abuse and post-traumatic stress disorder, David Olson, associate professor in the departments of Chemistry, and Biochemistry and Molecular Medicine at UC Davis, is searching for similar effects among compounds without the hallucinogenic effects of drugs like LSD. 

He calls these compounds psychoplastogens, for their ability to modify the brain.

See also  World’s first study on ketamine for behavioural addiction now complete

Olson commented: “I’m very excited that NIDA is recognising the potential that psychoplastogens might have for patients with substance use disorders.

“This grant will help us to understand the basic mechanisms by which these compounds impact addiction, and hopefully develop more effective and better-tolerated treatments.”

Olson’s work is part of a growing focus on psychedelics research at UC Davis and UC Davis Health. His lab has synthesised hundreds of molecules related to psychedelics in the search for new drug therapies. 

One such molecule, tabernanthalog, or TBG, produces both rapid and sustained anti-addictive effects in rodent models of heroin and alcohol self-administration.

The research will include mechanistic studies to understand how TBG impacts addiction and the development of new compounds with psychoplastogenic effects, he said. The team will use high-throughput screening to test for efficacy, safety and treatment potential. Promising compounds will undergo additional animal testing at CU Anschutz.

Delix Therapeutics, a startup founded by Olson, is also investigating non-hallucinogenic psychoplastogens for treating depression, anxiety and related disorders but is not involved in the project.

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Beckley Psytech strengthens leadership team as it progresses clinical pipeline

Dr Laura Trespidi has been appointed as chief development officer (CDO).

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Beckley Psytech strengthens leadership team as it progresses clinical pipeline

Dr Laura Trespidi is joining the Beckley Psytech leadership team as CDO, bringing more than 30 years’ experience in global pharmaceutical and biotechnology companies.

Trespidi will bring world-class leadership and technical expertise to the Beckley Psytech team, having worked across clinical product development and manufacturing, from pre-clinical research through to market approvals and global product launches. 

Trespidi will support the progression and development of Beckley Psytech’s investigational assets, including the proprietary formulations of intranasal 5-MeO-DMT, currently in Phase 1 studies.

See also  Beckley Psytech collaboration to develop next-gen psychedelic medicines

CEO of Beckley Psytech, Cosmo Feilding Mellen, said: “Dr Trespidi joins us as our chief development officer at an exciting time, with our lead drug candidates in Phase 1 clinical studies. Laura’s impressive track record and expertise across clinical development and manufacturing will be invaluable, as Beckley Psytech continues to grow and progress its clinical pipeline in this groundbreaking area of medicine.”

Trespidi’s former roles were placed at Summit Therapeutics and other leading companies such as Mundipharma, Shire Pharmaceuticals and GlaxoSmithKline. Most recently Trespidi worked as senior vice president of chemistry, manufacturing and controls (CMC), supply chain and technical operations at Summit Therapeutics, successfully leading global CMC and external manufacturing teams through the development and market preparedness of investigational medicines, including end-to-end supply chain and manufacturing readiness and expansion.

Trespidi’s expertise extends further to formulation development, technology transfers, outsourcing and offshoring, with additional experience developing and executing change management strategies. 

Throughout her career, Dr Trespidi has played a pivotal role in over 40 first-in-human clinical trials and pre-clinical trials, as well as contributing to four New Drug Applications (NDA) and market approvals, and over 40 Investigational New Drug (IND) applications.

Trespidi said: “I am thrilled to be joining Beckley Psytech at such a transformative time for the Company and for psychedelic medicines. 

“Beckley Psytech’s innovative pipeline has real potential to offer meaningful improvement to patients’ lives, and I am looking forward to working alongside a world-class team to turn this vision into a reality.”

Trespidi received her PhD in Pharmaceutical Science from the University of Milan, Italy; an MSc in Medicinal Chemistry and Biochemistry from the University of North Carolina, US; and in 2008 she received an M.B.A from the Open University Business School, UK. She has also authored a number of papers published in peer-reviewed journals and is a member of several scientific societies and associations.

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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