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.”
Clinical trial application submitted for psilocybe medicine
Numinus Wellness has submitted the application for a Phase I trial.
The application is for a clinical trial that intends to test the psilocybin extract for bioavailability and tolerability on 20 healthy volunteers.
HOPE is a two-phase study that will take place at a Numinus’ clinic in Vancouver. The company intends to begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers, if approved.
Science officer and general manager at its Health Canada-licensed research facility, Numinus Bioscience, Sharan Sidhu, commented: “This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies.
“The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development.
“This natural product has been developed to be shelf stable, minimally variable and consistently meet label claims. The trial will not only assess safety but also give us data on comparative bioavailability.”
“At Numinus, we are focused on developing products and services in-house to ensure that high-quality standards are maintained,” added Payton Nyquvest, founder and CEO.
”I am very proud of the Numinus team – from our Bioscience experts who developed the product, to our clinical research team who will administer the study.
“We look forward to achieving more milestones in our mission to make psychedelic-assisted therapies accessible to all who wish to safely use them.”
NBIO-01 is Numinus Bioscience’s first proprietary formulation developed from extracts generated using patent-pending technology.
A patent was earlier submitted to the US Patent and Trade Office and announced on June 24, 2021. The formulation has been developed to stably deliver psilocybin and other synergistic compounds.
Lion’s mane: what is it and why should I include it in my daily routine?
In this article, MyFunghi explores the benefits of the lion’s mane mushroom as a functional supplement to daily routines.
The lion’s mane mushroom has a long and complex history of being used as a supplement as part of a healthy diet.
Ancient civilisations were aware of the healing and wellbeing effects of lion’s mane and successfully harnessed them using a variety of ways including powders, tonics and tinctures.
Also known as Hericium erinaceus, the mushroom gets its nickname from the long, flowing, hair-like structures that grow from it, giving it the distinctive look of a shaggy lion’s mane. It can grow up the size of a football and is often found growing on dying or dead trees.
So how can his funny-looking fungus be beneficial to us?
Current research on its benefits show very promising results. Positively affecting every major organ in the human body, lion’s mane really is the miracle mushroom. Millions of people already use this fungus as part of their daily routine, so why should you?
Benefits of lion’s mane
Increased brain function and memory
This is probably one of the most well-known benefits. Known as a nootropic, which is a substance that can boost memory and mental capacity, it is thought to help some people improve their focus, memory and clear brain fog.
A study conducted with older adults showed that 3g daily caused a significant improvement in cognitive function and ability. There is also some research showing it can help repair and heal damage or trauma that is sustained to the brain.
Lion’s Mane has been shown to have strong anti-inflammatory properties. Recent studies with animals have shown that lion’s mane can effectively reduce chronic inflammation with long-term use. Inflammation can occur as a symptom of chronic illness or disease. Lion’s mane can offer relief to chronic inflammation and particularly help with inflamed joints due to arthritis as well as chronic bowel inflammation due to IBS, IBD and other such digestive diseases.
Recent research has shown that lion’s mane effectively reduces cholesterol which can reduce the risk of heart disease in later life.
Furthermore, studies have shown lion’s mane reduces the oxidation of cholesterol in the blood. Oxidized cholesterol molecules tend to attach to the walls of arteries of the heart.
This causes the arteries to harden, increasing the risk of heart attack and stroke. Therefore, reduced oxidisation of cholesterol in the bloodstream is hugely beneficial for maintaining a healthy heart.
As if this wonder mushroom couldn’t do anymore for the heart, the mushroom also contains a compound called hericenone B, which can decrease the rate of blood clotting further lowering the risk of heart attack or stroke.
Diabetes symptom relief
Diabetes occurs when an individual can no longer control blood sugar levels effectively and so the blood sugar levels in that individual remains at an elevated level. If left untreated this can result in severe complications from blindness, kidney disease, loss of limbs and even death.
Recent research has shown that the mushroom has significant promise in the treatment of high blood sugar levels, as several animal studies have shown that it can cause significantly lower blood sugar levels.
Lion’s mane lowers blood sugars by blocking the activity of the enzyme alpha-glucosidase, which breaks down carbs in the small intestine. When this enzyme is blocked, the body is unable to digest and absorb carbs as effectively, which results in lower blood sugar levels.
So with all these benefits, are there any side effects when taking lion’s mane?
No, studies have shown that lion’s mane is very safe to take with no adverse effects.
The exception to this is if you have an allergy or sensitivity to mushrooms. Lion’s mane is a variety of mushroom and if you have an allergy or sensitivity to mushrooms, we advise you contact your doctor before consuming.
Want to try and start benefiting from this miracle mushroom?
Head over to our organic oil. Here at MyFunghi.com our lion’s mane tincture is 8:1 concentrated and equivalent to 12,000mg per product, making it the most potent Lion’s Mane extract in the world.
You can find our lion’s mane by clicking here.
Psychedelic Health is not responsible for the contents of this article.
Ketamine-assisted therapy for alcohol addiction could save lives
Findings from the world’s first controlled study of ketamine-assisted psychotherapy for alcohol addiction have been published in the American Journal of Psychiatry.
The world’s first controlled study exploring the use of ketamine-assisted psychotherapy for the treatment of alcohol use disorder (AUD) has shown positive results.
Results from the Awakn Life Sciences’ Phase IIa/b study investigating ketamine-assisted therapy for the treatment of AUD has shown 86 per cent abstinence for six months following treatment. The therapy has the potential to save lives, according to the study’s lead researcher.
The primary and secondary endpoints of the double-blind placebo-controlled clinical trial, which included 96 patients with severe AUD, were days abstinent and relapse at six-month follow-up.
Results from the study have been published in the American Journal of Psychiatry.
“Alcohol Use Disorder is pervasive and persistent public health issue, affecting at least 390 million people globally. Treatment rates are low and relapse rates post-treatment tend to be high. We urgently need new and more effective treatments,” said psychopharmacology professor Celia Morgan, who led the trial conducted by the University of Exeter.
The findings demonstrated that ketamine combined with proprietary manualised therapy (KARE) therapy, resulted in total abstinence in 162 of 180 days in the following six-month period. This was an increase in abstinence from around 2 per cent prior to the trial to 86 per cent post-trial.
The results for relapse at six months showed that the Ketamine plus KARE group’s risk of relapse was 2.67 times less than the placebo plus alcohol education group.
Morgan, who is also Awakn’s head of ketamine-assisted therapy for addiction, added: “We found that controlled, low doses of ketamine combined with manualised psychological therapy can significantly increase post-treatment abstinence rates.
“This is extremely encouraging, as we normally see three out of four people returning to heavy drinking within six months of treatment. With the data we’ve collected from this study, along with emerging data from other studies of ketamine to treat AUD, they strongly suggest that further trials of this treatment are warranted.”
Participants in the trial were randomised into four groups. The first, three ketamine infusions plus KARE; the second, three saline infusions plus KARE; the third, three ketamine infusions plus alcohol education; and the fourth, three saline infusions plus alcohol education.
The secondary outcomes of the study also identified encouraging results including improved liver function across several different markers, a statistically significant decrease in depression after three months and a decrease in anhedonia, which is the inability to experience pleasure.
Morgan identified further significant results in the reduction in heavy drinking days.
At six months post-trial, there were only 12 heavy drinking days in the ketamine plus KARE group – a steep reduction compared to other trials in this area. For example, a US study of detoxified alcoholics in outpatient alcohol treatment reported 52 heavy drinking days at the same six-month marker and it is widely believed the real-world data is far higher than this.
There was also a 10-fold decrease in the risk of mortality; one in eight patients would have died within 12 months without treatment, a number which decreased to one in 80 following the treatment.
In total, the trial demonstrated that three subanaesthetic infusions of ketamine support abstinence from alcohol and that abstinence may be further enhanced when ketamine treatment is combined with therapy.
Anthony Tennyson, Awakn’s chief executive, commented: “We are so pleased to see such encouraging results in an area of treatment that has been stagnant for so long, leaving so many people with little or sub-par options available to them.
“We will continue to support this research and future clinical trials as we push to bring a radical shift in the alcohol addiction treatment industry.”
Awakn has acquired the intellectual property to the therapy under license for use in further research, its clinics in Europe, and its partnerships globally.
- Italian campaign on psychotropic substances has signatures verified
- Dealers licence for psychedelic medicines received by Psygen Labs
- Numinus wellness now trading on the Toronto Stock Exchange
- Clinical trial application submitted for psilocybe medicine
- Psilocybin for major depression trial launches at neuroscience institute
- Lion’s mane: what is it and why should I include it in my daily routine?
- Lion’s mane: what is it and why should I include it in my daily routine?
- Global coalition launches to push for psilocybin rescheduling
- Ketamine-assisted therapy for alcohol addiction could save lives
- Canada’s amendment allowing patients access to psychedelics welcomed
- New MHRA guidance will help with access to psychedelic medicines
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