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Exploring psychedelics for the treatment of dementia

Return Health is investigating the efficacy of psychedelic derivatives for halting the progression of the devastating condition.



Exploring psychedelics for the treatment of dementia

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. 

See also  Could psychedelics combat the cognitive decline of 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.”


Canada’s SAP patients to receive Blue Serenity psilocybin



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. 



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.



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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