Medicinal
Awakn: developing the next generation of psychedelic therapeutics
Establishing a network of psychedelic clinics in the UK, Awakn is hoping to help treat people living with addiction and mental health problems.

Published
2 years agoon

Co-founder and CEO Anthony Tennyson spoke to Psychedelic Health about Awakn’s mission to transform mental health and addiction care through psychedelics.
Biotechnology company Awakn Life Sciences has established the first-ever network of psychedelic-assisted therapy clinics in the UK and is developing the next generation of psychedelic therapeutics.
Its two-pronged approach of clinic provisions and drug development aims to provide transformative healthcare – combining drugs and therapies to better treat addiction and other mental health conditions such as anxiety, depression, PTSD and eating disorders.
Co-founded by Tennyson and world-leading psychedelic scientist and psychiatrist Dr Ben Sessa, the company has a robust team of experts in the field.
The team includes leading addiction scientist and global authority on psychedelics, Professor David Nutt; expert in neuroscience drug discovery, Dr Shaun McNulty; expert in ketamine-assisted psychotherapy for addiction, Professor Celia Morgan; and leading psychologist, Dr Laurie Higbed. Awakn is also working with Steve Page as an independent non-executive director, who has helped to build the largest network of mental healthcare hospitals and clinics in the UK.
CEO Anthony Tennyson, commented: “Addiction is substance addictions like alcohol and tobacco, prescription drugs, behaviour addictions like gambling, and also sexual behaviour and binge eating disorders. These are massive problems that are poorly treated. We have the ability to do a much better job than the incumbent industry – that is why we decided to focus on addiction.”
In the last year Awakn has acquired a number of assets, including exclusive rights to the world’s only Phase IIb clinical trial looking at ketamine-assisted psychotherapy for treating Alcohol Use Disorder (AUD), carried out by professor Celia Morgan, and the world’s only Phase IIa clinical trial looking at MDMA-assisted psychotherapy, also for the treatment of AUD.
“The core purpose of the company is to democratise psychedelics for the better treatment of addiction,” said Tennyson. “We are developing therapeutic package therapies and drugs to be used together. We are working with MDMA and ketamine in the near term to develop the therapy, but we are also developing our own drugs and therapies together into a single package in due course.
“Historically, companies have tried to treat addiction in two ways – with drugs or with talk therapy. With drugs, there tend to be three approaches. Trying to switch off individual receptor sites to stop the binding of the active ingredient and therefore negating the effects of those drugs. In our opinion, that is not a long-term solution. Another approach is to switch off other binding sites that create a craving, which may be may or may not be effective – once you stop taking those drugs and the craving comes right back.
“The other approach is swapping out one drug for another – swapping heroin for methadone, for example. It is not very effective. And talk therapy is not always effective for people.
“There is a massive societal problem. 20 per cent of the planet is affected by substance addiction or have a substance addiction. Gambling disorder affects up to 6 per cent of the population on the planet – that is up to 400 million people. Compulsive sexual behaviour, which includes pornography addiction, affect 5 per cent – up to 350 million people.
“So, we are coming to treating addiction in a revolutionary way. We are targeting the brain circuits rather than individual receptors – targeting a multi-receptor approach. There are essentially three levels to your brain, lower, mid and upper. Upper is your cognitive function, mid is the salience attribution – the importance upon which your brain or your personality applies to certain things – and the lower level is memory formation and reward.
“What happens in a normal brain, is that the cognitive part of the brain has control over the whole system and the connections between the whole system and the cognitive part are strongest. In an addicted brain, the cognitive part actually shrinks and the reward attribution part of the brain grows.
“We are using drugs to provide temporary disruption between the connections of those circuit levels. That provides temporary relief, but, in the space that disruption provides, we bring in proprietary psychotherapy to enable people to understand why they have a predisposition to consumption of addictive substances. That gives us the ability to work across both substance and behavioural addictions.”
Awakn’s ketamine programme and its overall research strategy have been set by Professor Nutt, and its data from Morgan’s ketamine-assisted psychotherapy trial will be published in the American Journal of Psychiatry, later this year.
“When published it will indicate that ketamine is quite effective at treating alcohol use disorder in combination psychotherapy. So, we are the only company in the world delivering evidence-backed ketamine-assisted psychotherapy for Alcohol Use Disorder [AUD]. We are also going to be licensing that into the North American markets. We are in discussions to see how we can bring that forward into a Phase III trial so that we can execute on our purpose, and could potentially have ketamine on-label in the UK for the treatment of AUD.
“We have also initiated a mechanistic study in conjunction with the University of Exeter to assess ketamine in the context of gambling addiction. We believe memory plays quite an important part in the dynamic of gambling addiction, and ketamine is quite effective at disrupting memories.
“So, we are trying to see how ketamine affects memory, recall and reward mechanisms in the brain for people who have a problem with gambling. If that is effective, and if there is a positive correlation, we will then look to bring that forward into later-stage research and follow the same path as with AUD.
“For MDMA, David, Ben and Laurie ran the Phase IIa trial that was published in February of this year in the Journal of Psychopharmacology. Typically speaking, there is a 75 per cent relapse rate with AUD. The team had between a 30 and 20 per cent relapse rate with the six and nine-month observation. It is a small safety and tolerability trial, but that is a strong paradigm shift in results. We are working to bring that research forward from Phase IIa to Phase IIb and to develop the clinical trial protocol.
“We have submitted that to The Medicines and Healthcare products Regulatory Agency (MHRA) for scientific advice. We have received our scientific advice. We are updating the protocol and intend to submit that for clinical trial approval this calendar year.”
Working with leading drug discovery, Evotec, Awakn has harnessed Artificial Intelligence (AI) to discover over 100 compounds that have the ability to interact at a neurobiological level in the same way as MDMA.
It recently announced the success of its new chemical entity (NCE) development programme, which has now identified a novel MDMA-like series. Four leading compounds have been selected to be taken into in vivo analysis to assess their efficacy for substance and behavioural addictions.
“MDMA is a bit of a challenge because it takes six hours to work, with a six-hour recovery window. The NHS does not have the facility to have someone sitting in a treatment room for six hours for 12 hours, so, we are looking to develop the next generation of entactogens that will disrupt brain circuits in the way that we want them disrupted – but will work in a potentially shorter window.
“We believe, based upon the evidence available, that psychedelics have the ability to transform how mental health and addiction are treated on an international level. So, we would hope that we will be able to treat addiction with a higher level of higher efficacy. We are in a position to really have a positive impact on families, individuals and communities, who are adversely affected by addiction and mental health – we like to think we have the ability to provide hope for people for whom the current status quo is not working.
“The only way that you can monetise this is you get it through trials and marketing authorisation, so the insurance companies will reimburse the public healthcare systems, and will be able to refer patients. If we can do that collectively and collaboratively we are in a position to really provide help to an awful lot of people.
“If that doesn’t happen – if regulation doesn’t move at speed and politicians get in the way and this remains off label, and remains only available to people who can pay for these kinds of services – that is a challenge. We are fully committed to doing the right thing, which is driving the research in order to secure democratisation, but working hand in hand with the capital markets – because capital markets gives us access to the capital to enable us to move faster. That, ultimately, will enable us to help more people much faster.”
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Medicinal
Integrating metaphysics into psychedelic therapy

Published
2 months agoon
29th September 2023
Dr Peter Sjöstedt-Hughes, Lecturer at Exeter University, has proposed incorporating metaphysical philosophy into psychedelic therapy to help improve therapeutic outcomes.
Sjöstedt-Hughes suggests that psychedelic therapy may gain more advantage by extending its scope into metaphysics, helping patients better integrate and understand psychedelic-induced metaphysical experiences.
Such improved outcomes may be seen if patients undergoing this therapy “are provided with an optional, additional, and intelligible schema and discussion of metaphysical options at the integrative phase of the therapy.”
In the paper, Sjöstedt-Hughes puts forward this schema as the “Metaphysics Matrix” and an accompanying “Metaphysics Matrix Questionnaire (MMQ)” which can be utilised by therapists and researchers as a tool for the quantitative measurement of a psychedelic experience.
The paper ‘On the need for metaphysics in psychedelic therapy and research’ has been published in Frontiers in Psychology.
What is metaphysics?
While mysticism deals with understanding the universe through direct experience, such as revelation, metaphysics is a branch of philosophy that deals with understanding the fundamental nature of reality through logic/argument.
Sjöstedt-Hughes writes that “metaphysics is not mysticism” but there is overlap: “[…] metaphysics is broader and its positions can be logically deliberated — as such metaphysics can encompass mystical experiences induced by psychedelic intake yet metaphysics can also ground those experiences in a manner that can be more intelligible, comprehensive, viable, and acceptable to participants than that which the framework of mysticism alone can offer.”
The Metaphysics Matrix
A number of clinical trials investigating psychedelic-assisted psychotherapy for the treatment of mental health conditions, such as anxiety and depression, report that participants who undergo a “mystical experience” during a psychedelic session often have higher levels of sustained therapeutic outcomes.
In clinical trials, mystical experiences are measured by different scales including the Mystical Experience Questionnaire (MEQ), the Hood Mysticism Scale (HMS), the Hallucinogen Rating Scale (HRS), the Five Dimensions Altered State of Consciousness Questionnaires (5D-ASC) and Eleven Dimensions Altered State of Consciousness Questionnaires (11D-ASC).
Sjöstedt-Hughes writes: “Data derived in this manner is obviously limited and abstract not only because psychedelic experience need not be “mystical,” but also because the definition of “mystical” could be expanded to include other criteria […]
“With regard to psychedelic-assisted psychotherapy […] speaking about mystical experience per se will not be sufficient to provide a meaningful explanation of the significance of such experience to a person, for the simple reason that mystical experience is the phenomenon to be explained — mystical experience is the explanandum rather than the explanation.
“It is metaphysics that is the means of explanation, the explanans of the mystical explanandum.”
The Metaphysics Matrix has been designed to provide a “menu” of metaphysical options that may help people to “frame, make sense of, and give significance to, their experiences”, and would be another tool in the belt of therapists to better understand these experiences.

Image provided by Dr Peter Sjöstedt-Hughes.
Such experiences could be understood through metaphysical systems such as Neutral Monism, Pantheism, Panpsychism, Animism, Substance Dualism, and Idealism, says Sjöstedt-Hughes.
Some examples provided include the common experience of the Universe being God – which can be understood in the context of Pantheism – or of all matter having a basic form of sentience – such as plants having a basic drive or process – which can be understood in the context of Panpsychism.

Image provided by Dr Peter Sjöstedt-Hughes.
Additionally, enabling people who have had these experiences to understand them within these frameworks may make them less likely to dismiss the experiences as delusional, says Sjöstedt-Hughes.
“ […] Relatedly, that the worldview hitherto adopted by the participant is but one metaphysical position amongst others,” he writes.
Sjöstedt-Hughes commented: “This is a conjecture that hasn’t been tested but can be tested – offering a patient an additional and optional discussion in the integrative phase of psychedelic-assisted psychotherapy.
“Giving them this Metaphysics Menu for integration may extend the long-term benefits of psychedelic therapy and beyond because there’s a number of studies that seem to show that certain peak psychedelic experiences have the longest and most beneficial health outputs results.
“If in the integrative phase [of therapy] one looks at that experience and starts to frame it intelligibly, then the conjecture is that the participant will not in a few weeks after that, think it must have been a delusion – they will say that we don’t know what reality is.
“Therefore, we can’t dismiss something as a delusion necessarily. By doing that it might extend the significance of that experience for the person.
“When we use Mysticism Scales, by definition, mystery can’t explain itself. Metaphysics, however, incorporates those experiences and offers an explanation to what they mean. For example, the relation between oneself and the universe.”
Sjöstedt-Hughes points out that in practice, one of the immediate issues is the practical issue of implementation of Metaphysics Integration, suggesting this could be supported through resources such as a handbook or practitioner training.
He further concludes the integration would need to be “further bridged by the therapist to the participant’s life, concerns, values, aims, and outlook.”
The Metaphysics Schema is already being utilised in studies taking place at Ohio State University, US, and Exeter University, UK.
Medicinal
Ketamine nasal spray for anxiety and PTSD advances

Published
4 months agoon
9th August 2023
Silo Pharma has announced it has advanced the formulation development for its therapeutic drug, SPC-15, which utilises ketamine.
The liquid nasal formulation will be used in SPC-15’s novel protocol that aims to treat and prevent anxiety, post-traumatic stress disorder (PTSD), and other stress-related disorders.
Chief Executive Officer of Silo Pharma, Eric Weisblum, stated: “The progress of our feasibility study investigating dose strengths of SPC-15 is a significant advancement in our development work with this pipeline candidate.
“Results of the feasibility study will determine our selection of the manufacturing processes, and we are currently in discussions with potential delivery partners.
“We may also use the feasibility data for upcoming studies related to our SPC-14 therapeutic targeting Alzheimer’s disease.”
The company has stated that the formulation development was in accordance with its sponsored research agreement and option with Columbia University, and that linearity, accuracy, and repeatability were achieved in the feasibility study.
In May 2023, Silo Pharma was awarded a U.S. Patent titled “Biomarkers for Efficacy of Prophylactic Treatments Against Stress-Induced Affective Disorders,” with claims protecting the key technology behind SPC-15 and further drug discovery.
The company is also carrying out a Sponsored Research Agreement with the University of California, San Francisco (UCSF) – Effect of Psilocybin on Inflammation in the Blood – which is investigating psilocybin’s effect on inflammatory activity in humans, with plans to accelerate its implementation as a potential treatment for Parkinson’s, chronic pain and bipolar disorder.
Medicinal
How psychedelics could help those living with alcohol use disorders

Published
4 months agoon
3rd August 2023
Alcohol use disorders (AUD) are estimated to affect around 237 million people across the globe, with 3 million deaths each year attributed to the harmful use of alcohol.
Despite this prevalence, there is a lack of effective treatment options and relapse rates remain high, but hope is on the horizon in the form of clinical research that is starting to show the therapeutic potential of psychedelic compounds for problematic drinking.
AUD affects millions of people around the world. In fact, approximately one in every 20 deaths globally are in some way related to alcohol, be it through disease, injury, or accident. There are over 600,000 dependent drinkers in England alone, and, in the US, roughly a third of people meet the criteria for AUD on a lifetime basis. Sadly though, only 21.9% of patients across the globe receive treatment for AUD and many struggle with relapse.
Why is this? Well, put simply, the treatment landscape for AUD is incredibly complex and there are many barriers throughout the treatment pipeline. Whether it’s the mental barrier of actually wanting to stop drinking, physical dependence, fear of withdrawal symptoms, the lack of awareness of what support is actually available, or the cost of treatment, it can be difficult for people living with AUD to know what to do.
And even if they are screened by a healthcare professional, the treatments available may not be effective for them. There may be undesired side effects and up to 70% of people taking pharmacological treatments for AUD find no positive outcomes. This means there is a huge unmet need for better, more effective and more accessible treatments – and this is where psychedelics come in.
How psychedelics are offering hope to those that struggle most
Thanks to a growing body of research, psychedelics have become a new medicine of interest for those looking to ease the burden substance use disorders have on individuals, families and healthcare systems. Psychedelics are believed to work by inducing a ‘window of neuroplasticity’ in the brain, which opens up the possibility for new behaviours or patterns of thinking to be developed. It is this ability that makes psychedelics so interesting in the case of treating conditions like AUD where addiction-related habits and emotions play a huge part.
The science is promising. In the U.S, a recent study led by the New York University Grossman School of Medicine showed that psilocybin treatment improved drinking outcomes in patients with AUD relative to outcomes observed with a placebo medication. Specifically, the study found that two doses of psilocybin, when combined with psychotherapy, reduced heavy drinking by 83%. Another study found that ibogaine, a psychedelic derived from the roots of a West African shrub, when used in conjunction with psychotherapy, could increase periods of abstinence in those with alcohol and other substance addictions.
At Beckley Psytech, we’re exploring the potential of our synthetic formulation of 5-MeO-DMT, BPL-003, for AUD in a Phase IIa study. Phase I healthy volunteer data has already shown that BPL-003 is well-tolerated and can reliably induce profound subjective experiences (a correlate of positive clinical outcomes) with a rapid onset and timely offset of perceptual effects. The Phase IIa study will explore the safety, efficacy and pharmacokinetics of BPL-003 alongside an abstinence-oriented cognitive behavioural programme in patients diagnosed with AUD. Topline results are expected later this year.
Collaboration is critical
It is, of course, still early days but the science seems to be indicating that psychedelics, when administered in the right context and with the right support, can help those who are suffering from a range of mental health conditions. With clinical studies progressing, and approval for other psychedelic treatments expected in the next few years, now is the time to develop the infrastructure that will allow us to actually deliver these interventions to people living with AUD. This involves us all: patients, regulators, investors, healthcare professionals and drug developers.
At Beckley Psytech, we are always looking to hear from others in the space so please head over to www.beckleypsytech.com to learn more about our work in AUD and how to get in touch.
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