Return Health is exploring psychedelic derivatives for the treatment of dementia. CEO, James Kuo, MD, spoke to Psychedelic Health about the company’s aims and its use of Artificial Intelligence for finding the best treatment candidate.
Biotech company Return Health is developing novel, non-hallucinogenic psychedelic derivatives to alter the progression of dementia. It is aiming to develop treatments that can reduce behavioural and psychological symptoms associated with the disease, and reverse cognitive decline.
According to the World Health Organisation (WHO), there are more than 55 million people living with dementia across the globe, with nearly 10 million new cases every year. Alzheimer’s causes around 50 per cent of all dementia, and there are currently no effective FDA-approved treatments for the disease.
“Dementia is perhaps the largest unsolved medical problem out there today, and we have partly ignored it and just let it continue,” says Kuo. “We are applying psychedelics toward treating dementia.
“We have broken down the problem into two components. The first one is the behavioural and psychological symptoms of dementia – which is the emotional and personality changes that occur. Sometimes they are the first indicator that someone has dementia, including symptoms such as anxiety, agitation, depression and apathy.
“We believe that psychedelics have already been shown in existing clinical trials to have efficacy there. So, we think we should be able to demonstrate that psychedelics are effective in treating those symptoms.”
Studies into psychedelics, such as DMT, have demonstrated that the compounds increase neural plasticity – an effect that could be beneficial in the treatment of dementia.
“There is also the cognitive decline aspect. We are targeting three mechanisms there. The first is neuroplasticity – which is rewiring the brain. In dementia, typically, the problem is with the prefrontal cortex or the hippocampus which is responsible for memory. So, if the brain is damaged, the best thing to do is to rewire the brain. So, we are focused on doing that as one mechanism.
“The second mechanism is regrowing nerve cells. That is an aspect that is not so familiar to people, but it is called neurogenesis and drugs like Prozac are capable of doing that. We are applying psychedelics for neurogenesis.
“The third one is reducing neural inflammation. There is a lot of inflammation, damage by the immune system, to the brain associated with Alzheimer’s, and reducing that would be tremendously helpful.”
Return Health is currently searching for the best new chemical entity that could help the disease by looking at tryptamine compound structures – the chemical backbone of psychedelics.
“We are not just targeting one serotonin receptor and 5-HT2A – the main receptor that most people focus on for the psychedelic effects – but there are other serotonin receptors that we think are very important for neurogenesis and for reducing neural inflammation.
“Most likely it is going to be something similar to DMT, because DMT has been the compound that, in animal studies, has been shown to be the best for neurogenesis and for cognitive decline. We believe we will do that within a year, then we will be ready for clinical studies with that compound.”
Return Health will be using Artificial Intelligence (AI)-assisted drug discovery to identify new psychedelic derivatives that have the effect they are looking for, but which will not have hallucinogenic properties.
“The way it is traditionally done within a pharmaceutical company is that you take chemical structures and make a lot of derivatives called a chemical library. And that can be thousands of them. You then put them through an assay, using what is called an in vitro assay, to see if there is any effect. That is a very expensive, laborious and time-consuming process.
“The new technology that has been rolling out throughout the pharmaceutical industry is utilising AI where this process is all done on a computer. You can do the vast majority of drug screening and then when you get to the shortlist of ideal candidates, you can synthesise them and test them in the in vitro assays in animal models. This way you can compress the lengthy, multi-year process into a relatively shorter time period,” says Kuo.
“There is actually several receptors that we want our ideal candidate to touch – some very lightly and other receptors we wanted to avoid completely. So, it is a case of programming the algorithm into the computer and then letting the computer go through the known universe of all the tryptamine structures out there – everything that has been in the public domain – and ranking each candidate chemical structure for its affinity for binding to the serotonin receptors we want to touch.”
Dementia is currently the seventh leading cause of death, and healthcare costs associated with the disease reach USD$817bn globally. Kuo says finding a treatment for the disease could lift a huge burden on health and social care for the disease, and bring hope to millions of families across the globe.
“Dementia destroys the lives of patients and impairs their brain function. They cannot live independently – simple things such as going out in your car to the store – you cannot figure your way home you get lost, or you forget to turn the stove off when you start cooking. Things like that can be very dangerous and obviously, highly impair someone.
“There is also the caregiver component – the disease is very devastating for the families having to care for a patient, and that is really one of the things that we are targeting. If we can target the behavioural and psychological symptoms of dementia, it would be much more effective to have someone take a pill than to have them be under supervised medical care. This would lead to tremendous cost savings. Perhaps this could be the one pill that saves more money in the healthcare system than anything else.
“The very interesting thing about psychedelics is that they appear to work on the worst patients, the patients who have failed everything else. Most drug developers do not like to go in that area because they feel it puts an undue burden on candidate drugs. If a patient is very sick, they may die of many causes that are not related to the drug, but if they die, then they’ll be attributed to the drug. Psychedelics are just the opposite. For example, in treatment-resistant depression, by definition, these patients have failed multiple therapies for their depression. Psychedelics seem to work better in that condition, and they also work for a longer duration of time after just one or two, possibly even three doses – sometimes for up to six months. So, they are really quite remarkable.
“There has been really no innovation in CNS [central nervous system] care for 33 years. That is a long period of time for very little to happen. The last innovation was really when Prozac was launched, and there were other similar drugs that followed. But, while they provided some relief for some patients, the vast majority were not helped by them. They have terrible side effects, like sexual dysfunction, which is probably the main reason why people do not take SSRIs.
“Psychedelics have a very colourful, interesting story because they were around before and they were very promising but then the government weighed in and restricted them – stopping all research. They are now coming back to life again after several decades of dormancy, and it is very exciting. There is a history of their use for thousands of years for spiritual and medicinal reasons, by shamans, for example. So, we are very excited to be working in this area and developing drugs for patients and their families who desperately need them.”
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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