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Heroic Hearts: investigating psilocybin for brain trauma in veterans

In part two of two, Heroic Hearts UK research director discusses the organisation’s groundbreaking study.

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Psychedelic retreats are mushrooming

Heroic Hearts UK research director Grace Blest-Hopley discusses the organisation’s groundbreaking study that will investigate the use of psilocybin for treating brain trauma in veterans.

Part two of two.

Heroic Hearts UK is conducting a groundbreaking observational study to investigate both the psychological and physiological effects of psilocybin on the brains of veterans who are living with post-traumatic stress disorder (PTSD) or traumatic brain injury (TBI).

The study will be carried out with The Centre for Psychedelic Research at Imperial College London and headed by leading psychedelic researcher Dr Robin Carhart-Harris.

Psilocybin for brain trauma

Current research into psilocybin focuses on its use for the treatment of mental health conditions such as anxiety and depression, with clinical trial results demonstrating the compound’s efficacy for major depressive disorder. More recently, hopes have been raised around the compound’s efficacy for the treatment of PTSD. 

Blest-Hopley points out, however, that alongside promising evidence of its psychological effects, there is emerging anecdotal evidence showing promise for the use of psilocybin as a treatment for TBI – a condition affecting up to 20% of soldiers who served in Afghanistan or Iraq, according to the Ministry of Defence, with many more possibly going undiagnosed.

“If we take it down to a biological level, we know that psilocybin works on the serotonin system and generates a feeling of wellbeing and happiness,” said Dr Blest-Hopley, a postdoctoral researcher at King’s College London.

“When your body is in danger there is a “fire alarm” that goes off and psilocybin seems to dampen the effect of that. From a psychological perspective, it enables you to discuss, process and think about traumas that you have had, without that fire alarm going off – processing the trauma in a much more cognitive way without the body reverting to the more primal fight or flight instincts.

See also  Are there interactions between psychedelics and psychiatric treatments?

“PTSD is this idea that the unconscious part of the brain holds on to the memories or feelings around particular incidents, and those incidents are not properly dealt with. So, by taking psilocybin, you are able to take those memories out, as it were and go through them, allowing the more unconscious parts of you to process them.”

Blest-Hopley explains that one of the distinguishing features of psilocybin compared to other therapeutic substances such as MDMA, is that the compound floods the functional neuronal connections in the brain – breaking down continuous and repetitive thought processes.

“It allows for thoughts to come in from other areas of the cortex, and not just be driven by these primaeval responses. Once you have gone past that acute experience you then get the after-effects of psilocybin. We have seen in studies that have looked at animals and cells that have been treated with psilocybin, that there are alterations in the cells, which increases plasticity and actually causes neurogenesis, which is actually growing more of those connections. It also increases the expression certain of genes – all of which are very relevant for head trauma.

“One thing that is now important to research further at the brain cell level, is the idea that psilocybin appears to show some kind of anti-inflammatory effect. We talk about psilocybin’s effects on the 5-HT2A receptor, but there is a lot of serotonin receptors involved, one of which is involved in inflammation.

“There is a lot of work to be done now on exactly which receptors psilocybin is engaging with. But there is certainly good evidence to suggest that is what’s happening. So, these are the reasons, acute and chronic, biological and psychological, of why we think psilocybin will work for PTSD and brain trauma.”

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At the retreat, the team will be using a number of different methods to measure the impact of psilocybin including electroencephalogram (EEG) brain imaging, which will look at the functioning of the brain and different brain oscillations as current research on PTSD suggests that brain oscillations are altered.

Cognitive and attentional testing will also be carried out using a computer programme that will assess memory, attention and finger tapping, to understand the participant’s motor control, alongside questionnaires to investigate psychological aspects such as depression, anxiety and PTSD, as well as a subject’s head trauma.

The importance of group setting, mystical experiences and integration

The study will also explore the importance of different aspects of using psilocybin as a treatment, including the group setting, the ceremonial, mystical and psychedelic experience itself, and the importance of psychological integration.

“Questions will be included around the idea of the psychedelic experience, as well as the ceremonial and mystical experience because that is something Imperial College are very interested in. After discussing with them, we wanted that to be part of our protocol as well, but also, as we move forward and we collect more evidence, I think it is important for us to start thinking about what the optimum environment for improvement looks like. 

“If we do get allowances to use these treatments in a few years time, is that going to be someone going into a very sterile clinical environment on their own and going through that process alone? Or, do we find that they will find the group experience to be part of that process of getting better?” 

Participants will also go through an integration process following the ceremony through a combination of group and individual sessions.

See also  US patent granted for psychedelics portfolio

“The integration is being conducted by an external party that has been working for a number of years, and are very well versed in, the integration of psychedelic experiences, as well as having worked with veterans.

“We want integration to be in a group environment to foster the idea of camaraderie which is spoken about often within veteran populations. We have also decided to add individual sessions which will be counselling, where participants can speak on a more personal level about things they may not initially want to divulge in a big group setting. They can explore how they felt at the retreats and what they have discovered about themselves – all the work does not happen on one night. Actually, it is in the weeks after.

“We are also hoping to develop an alumni network within the project where veterans who have gone through the programme will have a support network with each other after the retreat.

“I really think it is time that we break down the preconceptions that we have around these medicines and start looking at them in a really serious way, and how they can be used going forward with veterans.

“This population are incredibly deserving of treatment, and it is something they have been really let down on. I think it is time that the people in power, as it were, perhaps look at why we are holding the regulation in the position that we are considering the evidence that now exists.”

Hopes are that the study will act as a pilot for larger and more rigorous investigations of head traumas and PTSD, and of how valuable the group and ceremonial experience is. 

Read part one:

The journey behind Heroic Hearts: psychedelic healing for military veterans

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Research

Phase 2a trial to investigate 5-MeO-DMT candidate for alcohol use disorder

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Beckley Psytech and Clerkenwell Health are collaborating on a Phase 2a trial investigating Beckley’s synthetic 5-MeO-DMT candidate combined with psychological support as a treatment for alcohol use disorder (AUD).

AUD is estimated to affect around 237 million people across the globe and over 7.5 million people in the UK.

Treatment options for the harmful use of alcohol are not always effective – there are high relapse rates and there are around three million deaths each year attributed to the substance’s misuse.

Increasing research is showing that psychedelics may hold promise as innovative treatments for addiction, including substances such as ketamine and psilocybin.

See also  How psychedelics could help those living with alcohol use disorders

BPL-003 is Beckley Psytech’s short-duration and fast-acting synthetic formulation of 5-MeO-DMT – a psychedelic found in several plant species and the glands of at least one toad species – which is administered intranasally via an FDA-approved delivery device.

The compound has shown in Phase I data to be well-tolerated with a reproducible and dose-linear pharmacokinetic profile.

The Phase 2a trial

Beckley and Clerkenwell have confirmed that the collaborative Phase 2a open-label trial will evaluate the safety, tolerability and pharmacodynamic effects of a single dose of Beckley BPL-003 combined with abstinence-oriented psychological support in participants with AUD.

Currently taking place at King’s College London, Clerkenwell Health’s clinic near Harley Street, London, will provide an additional trial site.

According to Beckley, BPL-003 has been successful in eliciting psychedelic experiences of “similar intensity but shorter duration than psilocybin”.

Dr Henry Fisher, Chief Scientific Officer at Clerkenwell Health, stated: “An estimated 600,000 people are dependent on alcohol in England. This, coupled with an alarming increase in alcohol-related deaths of 89% over the past 20 years, shows the status quo isn’t working.

“Conventional treatments for alcohol dependency aren’t producing meaningful improvements and new avenues must be explored. This trial will assess whether psychedelic-assisted treatment can be an effective therapy for alcohol use disorder, with the hope of rolling out the treatment widely.

“Health professionals and policymakers should seriously consider such treatments, which could be genuinely ground-breaking for the NHS and for the hundreds of thousands of people being treated for alcohol use disorder in the UK.”

Beckley Psytech and Clerkenwell have emphasised that the results of the trial may be used to provide support for further study of psychedelic-assisted treatment for alcohol dependency.

Dr Rob Conley, Chief Medical and Scientific Officer at Beckley Psytech, added: “We’re committed to developing a transformative and effective treatment option for individuals struggling with alcohol use disorder.

“Based on our preclinical and Phase I data, we are optimistic about the potential therapeutic benefits of BPL-003 for substance use disorders and we are excited to evaluate the compound further in this clinical trial.

“I want to extend my thanks to the team at Clerkenwell Health and King’s, as well as to the patients who have joined, and will join, this study. Their participation, support and collaboration are absolutely critical to furthering research into this area of huge unmet need.”

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Research

The Entourage Effect in Mushrooms: Natural psilocybin may outperform synthetic

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The Entourage Effect in Mushrooms: Natural psilocybin may outperform synthetic

A new study from the Hebrew University-Hadassah Medical Center has indicated that natural psilocybin extracts may demonstrate superior efficacy to synthetic psilocybin extracts.

Recent years have seen a boom in research into psilocybin for the treatment of mental health conditions such as anxiety and depression.

Many of the clinical trials investigating psilocybin use synthetic extracts rather than natural ones. This is because synthetic extracts will contain psilocybin alone, whereas natural psilocybe mushroom extracts will contain several different compounds such as psilocybin, psilocin, baeocystin and norbaeocystin.

Having multiple compounds can pose a challenge when running clinical trials as identifying which compounds are active and what their impact is becomes difficult to measure, and the concentrations of these compounds can vary depending on factors such as growth conditions and processing techniques.

This makes the standardisation of multi-compound medicines a huge challenge, as medicine consistency, reproducibility and dosing become difficult. However, these are essential factors when it comes to conducting clinical trials and receiving approval for medicines from regulators.

The Entourage Effect

In 2011 Dr Ethan Russo put forward the theory of the Entourage Effect in cannabis. 

The cannabis plant contains over 400 different cannabinoids that have so far been identified, such as THC, CBD, CBN and CBG.

Russo hypothesised that these different cannabinoid compounds work synergistically to create a therapeutic effect, as opposed to compounds such as THC or CBD working in isolation.

This hypothesis has been touched on only a few times in the scientific literature in relation to psychedelic mushrooms.

For example, in Dr Jochen Gartz’s 1989 paper ‘Biotransformation of tryptamine derivatives in mycelial cultures of Psilocybe’ which proposed a synergistic relationship between compounds in the mushrooms, and a 2015 paper by Zhuck et al, ‘Research on Acute Toxicity and the Behavioral Effects of Methanolic Extract from Psilocybin Mushrooms and Psilocin in Mice’, which observed that the effect of psychedelic mushroom extracts on mice was much stronger than pure psilocybin.

There has been very limited research on this hypothesis in mushrooms since. 

A new study: Natural may outperform synthetic

Now, a research team from Hebrew University-Hadassah Medical Center BrainLabs Center for the Psychedelic Research have compared a natural psilocybin extract to a chemically synthesised version.

Published in Molecular Psychiatry, results from the study indicate that the natural extract increased the levels of synaptic proteins associated with neuroplasticity in key brain regions, including the frontal cortex, hippocampus, amygdala, and striatum.

The ability of psilocybin to induce neuralplasticity has been indicated as one of the key features that contribute to its therapeutic effects.

The researchers suggest that these new study results indicate that nautral psilocybin extracts may offer unique therapeutic effects that may not be not achievable with synthesised, single-compound psilocybin alone. 

Metabolomic analyses also revealed that the natural extract exhibited a distinct metabolic profile associated with oxidative stress and energy production pathways.

The researchers write: “In Western medicine, there has historically been a preference for isolating active compounds rather than utilising extracts, primarily for the sake of gaining better control over dosages and anticipating known effects during treatment. The challenge with working with extracts lay in the inability, in the past, to consistently produce the exact product with a consistent compound profile. 

“Contrastingly, ancient medicinal practices, particularly those attributing therapeutic benefits to psychedelic medicine, embraced the use of extracts or entire products, such as consuming the entire mushroom. Although Western medicine has long recognised the “entourage” effect associated with whole extracts, the significance of this approach has gained recent prominence.”

However, compared to cannabis, the researchers suggest that mushroom extracts present a unique case, as they are highly influenced by their growing environment such as substrate, light exposure temperature and more.

“Despite these influences, controlled cultivation allows for the taming of mushrooms, enabling the production of a replicable extract,” the team writes.

The researchers emphasise that this research underscores the superiority of extracts with diverse compounds, and also highlights the feasibility of incorporating them into Western medicine due to the controlled nature of mushroom cultivation.

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Markets & Industry

Psychedelics in 2024: a year for investment

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Psychedelics in 2024: a year for investment

Following several transformative milestones in psychedelics, coupled with a surge in biotech investment, 2024 is set to see a profound shift for the sector as investors turn their attention toward solutions in mental health.

With a remarkable 48% surge in biotech investment in the UK recorded between June and August 2023, according to data from the UK BioIndustry Association (BIA) and Clarivate, the financial landscape is ripe for innovative ventures.

This increase in investment followed the introduction of a new pension reform package which includes the Mansion House Compact. This allows pension providers to allocate 5% of default pension allocations to unlisted equity, which could equate to a massive £50bn in investment for UK companies.

Specific sectors highlighted for allocation include fintech, life sciences, biotech, and clean technology in order to create growth and support jobs across the UK.

This development presents a unique opportunity for the UK’s psychedelics industry to thrive.

Psychedelic developments

Parallel to this influx of biotech investment, the psychedelics industry has recently seen several watershed moments that are setting the stage for the sector’s acceleration.

In January 2024, UK-based Beckley Psytech secured $50M investment from atai Life Sciences to expedite the development of Beckley’s psychedelic assets through Phase 2 trials.

Multiple clinical readouts are expected from Beckley this year, including from its Phase 2a trial for Alcohol Use Disorder in mid-2024 and a Phase 2b readout of BPL-003, Beckley’s intranasal 5-MeO-DMT, for Treatment Resistant Depression in the second half of 2024.

See also  Negev: funding psychedelic research in Europe and North America

Additionally, Canadian-based Filament Health announced that the FDA has accepted its Investigational New Drug application for PEX010, a botanical psilocybin drug candidate aimed at treating Substance Use Disorders (SUD).

February saw the FDA accept Lykos Therapeutics’ (formerly MAPS PBC) NDA for MDMA-assisted therapy for PTSD. The application has been granted Priority Review and the FDA is expected to announce its decision in August 2024. If approved, this will be a major development for psychedelic therapies following two decades of research by MAPS.

Elsewhere across the globe, 2024 has already seen the European Medicines Agency confirm it will be holding a meeting on psychedelics in April to help shape regulatory guidance, and the UK’s independent body, POST, confirm it intends to publish a major briefing on psychedelic drugs to treat mental health conditions later this year.

The decision to publish the briefing followed the country’s first parliamentary debate on access to psychedelics in 2023.

Furthermore, Australia’s MindBio Therapeutics announced results from its pioneering Phase 2a take-home microdosing trial of its proprietary titratable form of LSD, MB22001.

The study showcased rapid and statistically significant improvements in depressive symptoms, with a 60% reduction observed and 53% of patients achieving complete remission from depression. The compound was shown to be safe and well-tolerated, with no treatment-related severe or serious adverse events reported.

These results mark a significant milestone in understanding the potential for scaling up psychedelic therapies, and the company is working on building a proprietary treatment model that is scalable, safe and effective, and can be tailored to patients as a first-line treatment for depression.

Speaking to Psychedelic Health, Co-Founder & Chief Executive Director of MindBio Therapeutics, Justin Hanka, stated: “Microdosing is a scalable way to treat millions of people suffering from these conditions with psychedelic medicines and this data just confirms it is safe and effective and justifies the progress of this research in advanced stage clinical trials.”

Most recently, Cybin announced it had received FDA Breakthrough Therapy Designation for its novel psychedelic molecule CYB003. This will provide an expedited review pathway and increased access to FDA guidance on trial design, as well as the potential to reduce drug development timelines.

Cybin CEO, Doug Drysdale, stated: “The granting of Breakthrough Therapy Designation by the FDA underscores the potential of CYB003 to fill a gap in the treatment landscape for MDD and serves to expedite and de-risk our development programme going forward.

“This designation provides for a streamlined review process and enhanced engagement with the FDA. With the robust durability data from our Phase 2 study in hand, we are ready to move forward expeditiously. We are grateful for the opportunity to accelerate the development and regulatory review process that this designation affords, as we prepare to advance CYB003 toward a Phase 3 pivotal trial around mid-year.”

The company also announced its oversubscribed private placement of US$150m in March, led by Deep Track Capital and includes participation from RA Capital Management, Avidity Partners, Acorn Bioventures, Altium Capital, Logos Capital, Octagon Capital, Rosalind Advisors, Sphera Healthcare and other institutional investors. The net proceeds will be used for Phase 3 drug development activities for CYB003, working capital and general corporate purposes.

Adding to these developments, the FDA recently gave Breakthrough Therapy Designation to Australia-based MindMed’s MM120 (LSD) programme for the treatment of generalised anxiety disorder (GAD), another bolster for psychedelic therapies.

Robert Barrow, Chief Executive Officer and Director of MindMed, stated: “The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provides further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD.”

Supporting investment

Israel-based Negev Capital, a biotech venture capital firm in the psychedelics-based medical R&D space, saw its successful first fund of $31 million invested across 27 companies including Beckley Psytech, MindBio and Filament Health.

Ken Belotsky, Partner at Negev Capital, commented: “We remain dedicated to supporting and investing in the future of psychedelic medicine and see 2024 as a watershed year for the sector.

“These recent achievements of just some of our portfolio companies underscore the immense potential of psychedelics-based compounds to revolutionise treatment of a wide range of mental health conditions, substance use disorders and other illnesses.’’

These major developments underscore a growing confidence in the potential of psychedelics to revolutionise healthcare and wellness, and investors are set to capitalise on their therapeutic potential bringing in a wave of investment.

The rest of 2024 is set to see regulatory approvals in the US and the advancement of clinical milestones which could see major shifts in valuations for companies in the sector.

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