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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.

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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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Markets & Industry

Netflix Premieres New Documentary on Ibogaine as Ambio Launches Europe’s First Physician-led Ibogaine Facility

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Ambio Life Sciences, a company known for its physician-led ibogaine therapy programmes, has been thrust into the global spotlight with the release of In Waves and War on Netflix, a documentary filmed at one of its treatment facilities, while simultaneously announcing the opening of its first European clinic in Malta. 

Ambio is a clinical organisation that offers medically supervised ibogaine programmes focused on trauma recovery, neuroregeneration and substance use disorders. The company’s leadership will be part of PSYCH Symposium: London 2025, occurring at London’s Conway Hall on December 4.

 In Waves and War 

The new Netflix documentary follows several former U.S. Navy SEALs as they confront the psychological and neurological scars of combat, including post-traumatic stress and traumatic brain injury, through ibogaine-assisted therapy. Filmed partly at Ambio’s clinic in Mexico, the film presents a rare, direct view of what such treatment entails and how it fits into the broader debate about the role of psychedelics in addressing mental health and substance use disorders.

In the film, Ambio showcases a clinical model that departs from the underground or informal settings that have long characterised ibogaine use. The company’s approach, grounded in medical oversight and structured aftercare, contrasts sharply with earlier practices and aligns with emerging calls for regulated, evidence-informed psychedelic care.

Ambio Life Sciences CEO and Co-Founder Jonathan Dickinson said to Psychedelic Health that the film’s timing is both urgent and consequential. “It is now 24 years after the start of the Global War on Terrorism, and rates of veteran suicide continue to rise. This film is being released to a global audience at a crucial time. The good news is, ibogaine is uniquely capable of addressing the intersection of mental health challenges, neurocognitive injury, and substance use,” he said. “Over the past five years, ibogaine in Mexico has quietly become the treatment of choice for the operator community, many describing immediate and lasting relief, often after years of failed conventional treatments.”

The documentary also foregrounds patient voices. Retired Navy SEAL and Ambio patient DJ Shipley, one of the film’s central figures, described his experience: “Ibogaine allowed me to become a better, more well-rounded version of myself, someone with more empathy, more compassion, but without losing my edge. I’m incredibly proud of my castmates and the directors. They did a beautiful job telling our story. I truly hope this film changes lives and helps people find strength in its vulnerability.”

The New Malta Clinic

Alongside the film’s debut, Ambio announced the launch of its new clinic in Malta, described as Europe’s first physician-led ibogaine facility. According to the company’s release, the centre offers a structured residential programme that combines medical screening, 24-hour physician supervision and integrated therapeutic support. Treatments will take place in a medically equipped environment with on-site emergency protocols, a full-time medical team, and facilities designed for private accommodation and holistic therapies such as breathwork and somatic work.

The Malta site marks Ambio’s first expansion beyond North America and establishes a strategic base for patients from Europe, Canada and the eastern United States. By creating a clinic that operates under formal medical oversight, Ambio seeks to raise safety standards and expand accessibility in a field that has often been criticised for its lack of regulation.

Ambio Life Sciences, founded by clinicians with experience treating addiction and trauma through ibogaine, positions itself as a provider of evidence-based, medically supervised psychedelic care. The company’s work has focused on neuroregenerative and trauma-related conditions, with a particular emphasis on veterans and first responders.

The combination of global media exposure and clinical expansion underscores Ambio’s role in shaping the public perception and practical delivery of ibogaine treatment. As both scrutiny and interest in psychedelic medicine intensify, Ambio’s visibility through In Waves and War and its new European operations will test how far the treatment can move toward mainstream medical acceptance.

Picture courtesy of Ambio Life Sciences.

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Evegreen

Psilocybin Shows Promise in Treating Obsessive-Compulsive Disorders: Is the Industry Getting Involved?

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A newly published systematic review titled on psilocybin’s effects on obsessive‑compulsive behaviours provides an up-to-date synthesis of research into the compound’s potential for treating OCD and related disorders. 

The study integrates findings from both animal models and early human trials, drawing attention to a consistent signal: reductions in obsessive or compulsive behaviours following psilocybin administration.

The review shows that in preclinical models (for example mice with altered grooming behaviours) psilocybin (or its active metabolite) produced marked reductions in compulsive-like behaviours, sometimes lasting beyond the immediate administration period. 

Clinically, although data remain limited, participants in early trials or case reports experienced rapid reductions in symptom severity (for example within hours or days) after single doses. The authors emphasise that while the mood-disorder applications of psilocybin are more advanced, this compulsive-behaviour indication is an important frontier.

In humans, single doses of psilocybin led to rapid symptom reductions. For example, in an open‑label study of nine treatment‑resistant OCD patients, reductions of 23 % to 100 % on the Y‑BOCS scale were recorded between 4 and 24 hours after dosing. A pilot trial in body dysmorphic disorder (a related OCRD) using a 25 mg psilocybin dose reported sustained improvements over 12 weeks in 58.3 % of participants. 

Mechanistically, the review highlights that psilocybin’s effects on compulsivity may not map exactly onto its classic psychedelic mechanism (5-HT₂A receptor activation). Some animal data suggest alternate or additional pathways (for instance 5-HT₇ receptor involvement, synaptic protein modulation) may underpin the anti-compulsive outcomes. The authors call for more robust, placebo-controlled human trials, ideally with neuroimaging and circuit-level biomarkers, to validate these early signals and clarify therapeutic protocols. 

The authors of the review emphasise that while the findings are promising, the evidence remains early stage. Key limitations include small clinical sample sizes, lack of placebo‑controls, short follow‑up intervals and heterogeneity in doses and models. They call for larger, double‑blind, placebo‑controlled trials incorporating neuroimaging of fronto‑striatal circuits, to more precisely map psilocybin’s effect in OCRDs. 

The authors propose that psilocybin may one day serve as a treatment for disorders characterised by repetitive, intrusive behaviours, not just mood disorders.

Are companies developing psilocybin-based treatments for OCD?

Several biotechnology companies are advancing psilocybin-based therapies for obsessive-compulsive disorder (OCD), signalling growing clinical interest in this area. 

Ceruvia Lifesciences has received U.S. FDA approval for an Investigational New Drug application to begin a Phase 2 trial using its synthetic psilocybin compound, SYNP-101, for OCD. The multicentre, randomised, double-blind, placebo-controlled study will administer a single oral dose and monitor participants for 12 weeks to assess symptom reduction, making it one of the most advanced OCD-focused psilocybin programmes.

Filament Health is developing PEX010, a botanical psilocybin drug exported to Israel for a trial investigating treatment-resistant OCD and PTSD.

MycoMedica Life Sciences lists OCD among its target indications, though its programmes remain early stage, while Compass Pathways is exploring broader psychiatric uses for COMP360, including potential applications in OCD.

Photo by Mélissa Jeanty on Unsplash.

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Insight

Is Ketamine Therapy Only Reaching The Wealthy? Dr. Celia Morgan On Expanding Equitable Access

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Dr. Celia Morgan is one of the UK’s leading figures in ketamine and psychedelic research, especially in the domain of addiction and mental health.

Based at the University of Exeter, she holds the Chair of Psychopharmacology and leads trials exploring how ketamine, paired with psychotherapy, can break cycles of relapse in substance misuse.

Morgan has led some of the largest clinical trials on ketamine-assisted therapy for alcohol use disorder and will be speaking at the upcoming PSYCH Symposium: London 2025, to be held at Conway Hall on December 4.

“I think that the most promising findings from our work with ketamine are of the sense of agency and autonomy in their recovery that the people we are working with experience,” she told Psychedelic Health in a written interview.

Still, she thinks several key challenges need to be tackled for these treatments to be able to reach more people. One of the biggest of such challenges is ensuring equitable access to these treatments.

“We see a relatively homogenous and privileged group in most studies, our work has tried to address this,” she said.

Building the infrastructure to safely deliver these treatments in public healthcare systems is another big challenge for the industry, she said.

Yet the healthcare sector can also take advantage of Ketamine’s regulated status to allow for a faster roll-out, when compared to other psychedelics like MDMA or psilocybin.

“Some of the recent recommendations by the Royal College fo Psychiatrists are steps on the way towards more widespread use,” she said.

What distinguishes Morgan in the psychedelics field is her dual commitment. She studies the risks and harms of recreational ketamine use while simultaneously designing controlled, clinical applications for it.

One of her flagship projects is Exeter’s KARE trial (Ketamine for Reduction of Alcohol Relapse), which blends ketamine infusions with psychotherapy for patients with alcohol use disorder. Early published data show dramatic improvements in abstinence rates during six-month follow-ups, far exceeding baseline relapse rates. Morgan has also worked on trials for gambling disorder and other behavioral addictions, expanding the frontier of what ketamine-assisted therapy might treat.

Morgan also plays a role in academia’s response to the psychedelic renaissance, she’s a co-lead on Exeter’s postgraduate certificate in psychedelic studies, a program designed to train clinicians, researchers, and therapists in the science and ethics of psychedelic medicine.

“I think its important to keep on with our efforts to study, regulate and roll out these treatments principally for the patients who might benefit from psychedelics as I have seen first hand in my work,” she said.

Picture is extracted from an interview with Dr. Morgan at PSYCH Symposium’s 2022 edition.

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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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