The UK’s first trade association for psychedelics – Psychedelic Industry UK (PsyIndyUK) – has launched today, 18 September, to represent the country’s growing psychedelic medicine sector.

PsyIndUK has launched to encourage collaboration and knowledge sharing across the psychedelics industry, as well as representing the sector with policymakers and regulators.

2024 has been a turbulent year for the development of psychedelic medicines, with some unexpected setbacks and overpromising. To counter this, a shared mission of PsyIndUK is to build the future of psychedelic medicine in the UK in a sustainable, evidence-based, and equitable way.

The team leading the trade association has decades of experience in undertaking scientific research, raising capital, running organisations, and political and regulatory engagement.

Led by psychedelics regulatory expert James Bunn, the PsyIndUK team also includes chair Dr Rayyan Zafar of Imperial College, and advisors Lucas McHugh and Mike Morgan-Giles.

Psychedelic Industry UK CEO James Bunn commented: “We’re proud to announce the launch of Psychedelic Industry UK. Now is the right time for this nascent industry to come together and collaborate to drive progress.

“Psychedelic Industry UK is delighted to welcome a range of leading players in the UK industry as founding members, with others expected to join in the coming period.”

PsyIndUK will take a holistic approach to psychedelic medicines, but will focus primarily on psilocybin, LSD, mescaline, DMT, MDMA, and ketamine.

Psychedelic Industry UK Chair Dr Rayyan Zafar added: “The psychedelic industry is expanding at a rapid pace, with notable progress with clinical trials and a growing recognition among the medical and wellness community.

“PsyIndUK is committed to rigorous scientific and medical research to guide therapeutic delivery, professional training for healthcare providers, and regulations to protect patient safety. We look forward to working across the sector to achieve this.”

The founding members of PsyIndUK are as follows:

• Heroic Hearts
• Onaya
• Psilonautica
• PsyAware
• Psych
• Psychedelic Health
• PsyEdu
• Shortwave Life Sciences
• Volteface

Membership of PsyIndUK is open to companies and groups across the UK’s psychedelics space. Members will receive a range of benefits and services, including working groups, events, and advocacy. To find out more, please visit www.psyind.uk

Awakn Life Sciences has entered into a new collaboration with Graft Polymer to advance its New Chemical Entity (NCE) programme, developing novel molecules for innovative addiction and mental health treatments. 

Both MDMA and ketamine have been showing promise as innovative mental health treatments for conditions such as depression, anxiety, and PTSD. However, these treatments can take hours to administer and use up high amounts of staff resources.

Awakn’s new collaboration with biopolymer drug delivery systems company Graft Polymer (LON: GPL) will be harnessing Graft Polymer’s expertise to develop Awakn’s Aminoindane NCE programme.

LSE-listed Graft Polymer develops biopolymer drug delivery systems and has a proprietary patented platform – a bioabsorbable self-nanoemulsifying drug delivery system (SNEDDS), which represents a cutting-edge solution in drug delivery technology. 

The NCE programme aims to reduce the time the therapies last, improve accessibility and reduce strains on healthcare resources. 

Professor David Nutt, Chief Research Officer at Awakn Life Sciences and Senior Scientific Advisor for Graft Polymer, sat down with Psychedelic Health to tell us more. 

Helping transformative mental health therapies reach patients

The new collaboration will see an initial phase focused on completing pre-clinical research activities, and Graft Polymer will contribute £300,000 along with its expertise in novel drug delivery systems in a bid to enhance bioavailability and improve the pharmacokinetics of the Aminoindane NCEs. 

“We’ve been working on programmes to try to see if we can improve acute, rapid-acting treatments with ketamine and with MDMA,” explained Professor Nutt.

“There are two ways to do that. One is to develop new molecules, which is complex and expensive and needs a lot of investment. The other is to see if we can improve on the kinetics, and there are different ways of doing that. 

“You can get different routes – you can go through sublingually, you can go through buccally, you could go through the skin. But those different approaches need different formulations. Graph Polymer has a nanosphere formulation that they develop, which might begin to minimize some of the peripheral metabolism of both currently existing molecules, and you could potentially reformulate MDMA or ketamine. 

“If you develop new molecules, you want to optimize the kinetics, and that technology can be very helpful.”

“Optimising ketamine to make sure you get the optimal duration, speed of onset, speed of offset, and functional occupation of the brain, that’s never been done before.”

“MDMA is less challenging because currently, the MDMA treatment takes all day.

“If you’re giving someone MDMA therapy for PTSD, they come in at nine, they get the medicine at 10, and they don’t leave till five or six. That’s hugely tiring for the patient. It’s stressful for the therapists, because you have got to have someone present all the time, and no one knows whether that’s optimal.”

Reducing the time these treatments take will enable the scale-up of psychedelic therapy, allowing more patients to be treated, as well as improving the therapy’s safety due to less exposure time to the compounds.

Using Graft Polymer’s technology, which integrates active pharmaceutical ingredients into novel, patented delivery systems, the collaboration aims to to improve the bioavailability, pharmacokinetics, and stability of MDMA and ketamine. 

“We’re certainly going to be aiming to improve tolerability as well as the kinetics gap, but the scalability of MDMA therapy is the biggest challenge,” added Professor Nutt. 

“The other way is to look at therapies which can be given in groups. You can do four or five people at the time, so you might get it down from 10 hours with one person, to to three hours with 10 people. 

“Then we can begin to see how to approach the public health issue of trauma.”

Accelerating psychedelic therapies in the UK

The UK is currently facing a mental health crisis with one in six people in the UK living with some form of mental health condition, and with suicide being the leading cause of death in men under 50.

Equally, with unprecedented waiting times for therapy and no innovation in mental health treatments since the advent of SSRIs, there is a desperate need for new and effective mental health therapies.

Historically, the UK has been a leader in psychedelic research and remains so today, with multiple research institutions and companies developing cutting-edge treatments. However, current regulatory barriers are making it difficult to bring psychedelic therapies to UK patients.

“The problem we have in the UK is that we’ve got great science, but in terms of rolling it from the research lab into clinical treatment is proving quite difficult. However, we now have a new government, so there’s a chance for things to change,” commented Professor Nutt.

“Up to now, the decision-making about so-called “illegal” drugs has been driven almost completely by the Home Office which has wanted to stop people using these drugs recreationally. That has impeded research. 

“I hope the new government will be much more open-minded because there is very little evidence that current drug laws stop use. However, they certainly stop research. There are around six universities that have got a license to work with these drugs clinically and we’ve got to change that.”

Nutt highlights that the compounds in Awakn’s NCE programme are not controlled drugs, providing huge advantages in terms of both the costs of development and the costs of rolling the therapies out, as well as making it easier for hospitals to pharmacies to hold the compounds. 

“There’s a huge amount of pressure developing now to, at the very least, get the scheduling altered so that researchers can really go ahead and find out the real potential of these therapies,” added Professor Nutt.

“We have a crisis but people are not looking at solutions to the crisis. Psychedelics, entactogens, they are much more powerful treatments for trauma disorders than anything we’ve ever had, and we should be investing heavily in them and facilitating the research.”

“At Awakn, we are hoping that the governments will see the light. If you look back 20 years, there were no companies in this space. Now, there are probably worldwide, 40 to 50 companies. 

“The door is open for the UK if we want to walk through it. We could be innovative. We should. Whether we will, that’s a political, not a scientific decision.”

With the upcoming decision on Lykos Therapeutics (formerly MAPS Public Benefit Corporation) MDMA therapy from the US FDA later this month, the outcome may hugely influence decisions by policymakers elsewhere in the world, including the UK.

“I think the MHRA would be reluctant to be the first in the world to fully approve. If the FDA supports it, that will give the whole field an enormous boost, because the current MAPS therapy works. Now all we have got to do is optimize it.”

Shortwave Life Sciences, previously Psych Capital, has received a positive patent report from the PCT confirming its mucoadhesive buccal film as a novel and inventive drug delivery platform for psychedelic-based drugs.

Shortwave Life Sciences (PSY:Aquis AQSE) is working to transform Anorexia nervosa care through innovative approaches and treatments, including psychedelics.

Anorexia nervosa is a complex mental health condition as well as a metabolic disease, with one of the highest fatality rates. However, there is currently no FDA-approved pharmacological treatment for the condition, underlining an urgent need for innovation in this area.

To tackle this challenge, Shortwave Life Sciences has developed a novel drug based on psilocybin and another API, which Shortwave says provides an expanded mechanism of action and a therapeutic effect superior to psilocybin alone, impacting more than one group of receptors in the brain.

The company has developed its novel delivery method in the form of a buccal film. This method of administration is designed to be sensitive to patient needs, who may not want to swallow the medicine, and also provides higher bioavailability.

Positive patent report

Shortwave recently received its positive report from the PCT examining authority acknowledging all of its claims regarding its buccal film as novel, non-obvious and industrially applicable, marking a major milestone for the company.

Rivki Stern Youdkevich, CEO of Shortwave Life Sciences, commented: “This acknowledgement by the PCT committee is very important for us as we progress in our drug development path.

“The PCT’s examining committee’s report acknowledging all our claims as free of prior art confirms our belief in our patient-focused IP and drug development strategy. As we move to the national phase, we are reaffirmed in our mission of pioneering breakthrough therapies that transform the landscape of mental health care, especially psychedelics-based.”

With this IP confirmation, Shortwave has confirmed it can now begin to utilise its buccal film delivery platform, which is currently in clinical testing, in administering additional drug combinations including under licensing agreements with future potential partners.

Stern Youdkevich continued: “Our Buccal film, which is a topical route of administration applied in the cheek, allows our psilocybin-based drug combination to diffuse through the oral mucosa and enter directly into the bloodstream, providing better bioavailability and more rapid onset of action compared to oral administration because the medication does not pass through the digestive system and thereby avoids first-pass metabolism.

“We believe this can be extremely beneficial for anorexia nervosa patients who experience severe metabolism-related challenges. We are very excited to study this further in our upcoming clinical trials coming up.”

The company has stated that it is aiming for a rapid approval process through the FDA pathway for approval.