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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.



Study to investigate 5-MeO-DMT candidate for alcohol use disorder

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.

See also  NHS Trust enters MOU to increase psychedelic-assisted therapy in 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.

See also  Awakn’s second psychedelic therapy clinic to open in London 

“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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MDMA for PTSD receives priority review for New Drug Application



Photo by iStrfry , Marcus on Unsplash

Lykos Therapeutics, formerly MAPS Public Benefit Corporation, has announced it has received FDA acceptance and priority review for a New Drug Application (NDA) concerning its MDMA-assisted therapy for PTSD.

The FDA has accepted Lykos’s NDA for MDMA capsules used in combination with psychological intervention. This intervention includes psychotherapy and other supportive services provided by a qualified healthcare provider for individuals with PTSD. 

Lykos has stated that the FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024. Current statistics show that 89% of applications that meet their PDUFA deadline are approved. If this application is approved, it would make this the first MDMA-assisted therapy and psychedelic-assisted therapy.

In a press statement, Amy Emerson, chief executive officer of Lykos Therapeutics, commented: “Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD.

“We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved.”

The NDA submission was supported by results from several studies on the therapy, including two Phase 3 studies that looked at the efficacy and safety of the therapy. Both of these studies met their primary endpoints, which were a change in PTSD symptom severity and an improvement in functional impairment associated with PTSD. 

While no serious adverse events were reported in the MDMA group in either study, Lykos highlights that the safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.

The news has been welcomed across the pond by European campaign groups advocating for access to psychedelic-assisted therapy. 

In a press statement, campaign group PAREA commented: “Innovation in mental health has stagnated for decades. In the past three years, Europe has approved only one new psychiatric treatment, compared to 68 in oncology. 

“While the U.S. is on the brink of approving the first psychedelic-assisted therapy, Europe significantly lags behind. This is primarily because the current incentives and rewards for companies to conduct large-scale pivotal trials on psychedelics are insufficient in Europe, highlighting the need for enhanced support and incentives to advance novel mental health treatments.”

While the US makes strides in advancing psychedelic healthcare, Europe is now beginning to take note of this scientific development, with the European Medicines Agency (EMA) set to hold a multi-stakeholder workshop on medical psychedelics in April 2024.

The workshop aims to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe.

The continent also made a recent historic advancement in the field of psychedelic research. In January 2024, the European Union announced €6.5 million in funding for research into psychedelic therapy as part of its Horizon Europe programme. 

The funding has been awarded to a consortium of 19 partners from nine different European countries for a clinical trial – the PsyPal trial – which will study psilocybin-assisted psychotherapy for psychological and existential distress in people who are diagnosed with either chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) or atypical Parkinson’s disease (APD). 

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Doctors warn against potentially harmful psychedelic “trip killers”



Photo by Altin Ferreira on Unsplash

Doctors have raised a warning against so-called “trip killers” that are used to end challenging psychedelic experiences on compounds such as LSD or psilocybin.

The doctors have published the warning in a letter in the Emergency Medicine Journal. In the letter, an analysis of relevant Reddit threads is provided that show drugs such as benzodiazepines and antipsychotics recommended to help end these challenging psychedelic experiences. However, the doctors emphasise that these recommendations rarely include information about potential side effects.

A total of 128 Reddit threads created were discovered that were created between 2015 and 2023, yielding a total of 709 posts. With 440 recommendations, amounting to nearly half – 46% – of all the ‘trip-killers’ mentioned in posts, were various benzodiazepines, followed by several different antipsychotics at 171%.

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The team found that one in 10 recommendations were for antidepressants, while one in 20 were for alcohol. Opioids, antihistamines, herbal remedies, such as camomile and valerian, and prescribed sleeping pills, attracted 3% each, with cannabis and cannabidiol at 2%.

Trip-killers were mostly discussed in reference to countering the effects of LSD (235 recommendations), magic mushrooms (143), and MDMA (21). Only 58 posts mentioned potentially harmful side effects.

The authors write: “The popularity of benzodiazepines raises concerns. Benzodiazepines are addictive and have been repeatedly implicated in overdose deaths. 

“The doses described on Reddit risk over-sedation, hypotension [low blood pressure], and respiratory depression [stopping breathing or shallow breathing].”

Doses of one of the recommended antipsychotics, quetiapine, were also high the authors note, with only a few posts differentiating between fast and slower release formulations.

“Information on trip-killers isn’t available through drug advice services, despite the probable risks they pose,” highlight the authors.

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Integrating metaphysics into psychedelic therapy



Integrating metaphysics into psychedelic therapy

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.” 

See also  Study explores relationship between psychedelics and consciousness

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.

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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.

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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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