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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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Awakn: developing the next generation of psychedelic therapeutics

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.”

Medicinal

Canada’s SAP patients to receive Blue Serenity psilocybin

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Canada’s SAP patients to receive Blue Serenity psilocybin

Optimi Health has launched Blue Serenity – Canada’s first natural therapeutic psilocybin product, in collaboration with psilocybin patient advocate Thomas Hartle.

Once approved by health authorities under Canada’s Special Access Program (SAP) or an authorized clinical trial, patients, doctors, and researchers will receive Blue Serenity in blister packs of eight psilocybin capsules.

Blue Serenity is standardised to contain a total of 25 milligrams of natural psilocybin in the form of EU-GMP biomass grown as Panaeolus cyanescens mushrooms cultivated at Optimi Labs Inc. in Princeton, British Columbia. 

See also  Brain activity in depressed people increases following psilocybin use

Optimi’s Chief Science Officer, Justin Kirkland, and Head of Cultivation, Todd Henderson, collaborated with Hartle to breed a specific genetic strain based on Hartle’s previous therapeutic experiences.

Optimi CEO, Bill Ciprick, commented: “Anyone who has entered the psychedelics space in the last two years will tell you that Thomas Hartle’s story of compassion and kindness inspired them in some way to want to make a difference.

“We are tremendously excited to be partnering with Thomas to become the first Canadian company to launch a natural psilocybin product specifically to help patients seeking relief through the Special Access Program.”

Proceeds from the sale of Blue Serenity will directly benefit psilocybin patients through Hartle’s new charity, a venture that will provide access to psilocybin therapy for underserved adults. 

Optimi will also make a $5,000 monetary donation to the charity in commemoration of the two-year anniversary of Hartle’s Health Canada approval to undergo psilocybin-assisted therapy.

Ciprick said: “It’s an excellent opportunity for Optimi to give back to those in need, while helping to build a network of trust between business, advocacy, patients, and doctors, that we hope will further the framework for compliant access and increase the overall confidence of practitioners in this medicine.”

Optimi Health has explained that Hartle’s choice of the name “Blue Serenity” touches on the emotional and visual aspect of his psilocybin experience, specifically in how he was able to redefine the inner sense of peace his therapy brought him.

Hartle said: “Blue Serenity was born from an experience that took me from a state of extreme anxiety to a feeling of calm that I never knew existed.

“Knowing that my journey will live on in a natural substance that others will be able to access goes to the core of everything that is right about psychedelic therapy, and that in itself is an incredibly moving experience for me.”

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Project Solace: world’s largest medical psilocybin access and data project launches

The project will be led by Canadian non-profit TheraPsil in conjunction with UK non-profit Drug Science. 

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Project Solace medical psilocybin access and data project launches

In a move that aims to provide patients in Canada with the “life-changing opportunity” to receive psilocybin-assisted psychotherapy, TheraPsil and Drug Science are collaborating to launch ‘Project Solace’.

Project Solace is a medical psilocybin access and data project aiming to inform the development of regulated psilocybin therapy. The project will be working to expand legal access to medical psilocybin for patients in Canada, and collect evidence documenting psilocybin-assisted psychotherapy.

Using a real-world data registry, the non-profit organisations will be collaborating to collect anonymised data through Project Solace. The data will be provided to regulatory bodies, including Health Canada, to facilitate decision-making surrounding the regulatory system for the future of medicalised psilocybin.

Access to psilocybin-assisted psychotherapy in Canada is currently only authorised through Canada’s Special Access Program (SAP) in emergency situations. The SAP is Health Canada’s preferred pathway, outside of clinical trials, for patients in medical need to access legal psilocybin-assisted psychotherapy and psilocybin for medical purposes. 

See also  Canada's amendment allowing patients access to psychedelics welcomed

TheraPsil, which is dedicated to advocating for patients in medical need of psilocybin and psilocybin-assisted psychotherapy, and Drug Science, an independent scientific body on drugs in the UK, emphasise that the SAP is inaccessible to many patients, as:

  • The SAP is limited to emergency situations where other treatments have been tried and failed. 
  • Accessing the SAP requires working through layers of bureaucracy and puts unfettered discretion in the hands of the government. 
  • Healthcare professionals who are proficient in psilocybin-assisted psychotherapy, and carry the confidence to request this treatment option, are few and far between.

Professor of Neuropsychopharmacology at Imperial College London and founder and chair of Drug Science, David Nutt, stated: “The Canadian Special Access Program has the potential to provide thousands of Canadian patients with a life-changing opportunity to receive psilocybin-assisted psychotherapy from a team of trained medical professionals. 

“The clinical trial procedure is not an appropriate process for many patients due to the severity of the conditions that psilocybin-assisted psychotherapy attends to treat. Project Solace will be the largest database of prescribed psilocybin in the world and real-world data gathering helps us to understand how these drugs are affecting patients.” 

See also  Patient approved to receive psilocybin therapy for MDD

A patient who has been able to access a psilocybin-based medical product with TheraPsil’s support, Thomas Hartle, commented: “Getting access to this proven treatment through the SAP is bittersweet for me. I am grateful to receive the treatment. 

“However, the vast majority of Canadians who need this therapy do  not have access to the level of professional support that TheraPsil provided to me, and that played such a great role in my SAP application being approved.”

Aims of the project

The project aims to expand legal access to psilocybin medicine for patients in Canada suffering from conditions such as end-of-life distress, Major Depressive Disorder and other serious conditions, which have failed to respond to traditional treatment options. 

It also aims to develop a substantial body of evidence, using a real-world data registry, to document clinical effectiveness, safety and clinician and patient reported outcomes in patients who have received psilocybin-assisted psychotherapy through Canada’s Special Access Program (the SAP), or, under exemptions authorizing possession of psilocybin.

See also  Global coalition launches to push for psilocybin rescheduling 

Through Project Solace, TheraPsil will support prescribing healthcare practitioners in Canada to feel confident and capable to request psilocybin-based medical products on behalf of their patients through the SAP. 

As part of ensuring patient safety and treatment efficacy, TheraPsil will also identify and connect prescribing healthcare professionals with trained treatment therapy teams across Canada that will support patients in medical need through the facilitation of psilocybin-assisted psychotherapy. 

See also  Calls for psilocybin access rights for UK cluster headache sufferers

Director of research at TheraPsil, Julia Joyes, Msc, highlighted: “The SAP represents a giant leap forward in our healthcare system, allowing unprecedented early access to medications that are clearly on the path to full Health Canada approval. 

“This expanded access also presents an invaluable opportunity to collect real-world data on the  use of psychedelic medicine in clinical practice. 

“We should certainly cherish this opportunity.”

TheraPsil will help patients connect to prescribing healthcare professionals who can request cGMP psilocybin from licensed dealers enrolled in Project Solace – including HAVN Life Sciences, Filament Health and Psygen.

Project Solace plans to begin assisting patients in five primary regions in British Columbia, Ontario and Quebec, and plans to expand as additional treatment teams are onboarded.

The data will be released to licensed dealers enrolled in Project Solace and the general public. 

Patients who consent to participate in Project Solace will complete standard healthcare questions at various points in their psilocybin-therapy journey.

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IND application submitted for psilocybin alcohol use disorder programme

B.More has submitted the application.

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IND application submitted for psilocybin alcohol use disorder programme

B.More has submitted an Investigational New Drug (IND) application for its Psilocybin Alcohol Use Disorder Programme.

According to the US Centers for Disease Control and Prevention, excessive alcohol use kills roughly 95,000 Americans each year and is the leading cause of preventable death.  

In addition to increased risk of chronic disease and death, excessive alcohol use can negatively impact memory, learning and mental health and carries massive economic and social costs.

See also  Ketamine-assisted therapy for alcohol addiction could save lives

B.More is a non-profit, clinical-stage biopharmaceutical company focused on the development of psychedelic medicines for substance abuse disorders. Founded in 2017 by Carey and Claudia Turnbull, B.More is named after Claudia Turnbull’s brother, Brett Moore, who died of a drug overdose 50 years ago

The company has submitted the application to begin a Phase 2b trial to determine the efficacy and safety of synthetic psilocybin (SYNP-101) in treating alcohol use disorder (AUD).  

The trial, which will be initiated in early 2023, will be led by principal investigator Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine.

Co-founder and CEO of B.More, Carey Turnbull, commented: “B.More’s psilocybin AUD program IND application is a major step forward in our mission to develop psychedelic medicines for individuals struggling with alcohol use disorder.  

“Our Phase 2b trial builds on the impressive work led by Dr Bogenschutz and will provide vital data to further advance our drug development programme.”

B.More’s Phase 2b, multicentre, randomised, double-blind, active placebo-controlled clinical trial will assess the 24-week efficacy and safety of synthetic psilocybin (SYNP-101) in treating moderate to severe alcohol use disorder (AUD).  

With a planned 226 participants, it will be the second largest psychedelics clinical trial ever conducted.

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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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