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Developing a gold standard for psychedelic care

Clerkenwell Health is aiming to accelerate the development of efficacy data and help deliver psychedelic clinical trials at speed and scale.

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Developing a gold standard for psychedelic clinical trials in Europe

UK company Clerkenwell Health is working to develop a gold standard in the delivery of psychedelic care.

Clinical trial company Clerkenwell Health is embarking on institutional partnerships to conduct psychedelic research and drug development, helping psychedelic compound manufacturers commercialise their products. The company is also building the first custom-designed Centre of Excellence for psychedelic clinical trials.

By focusing its research on the benefits of therapy alongside supportive technologies, Clerkenwell aims to create a best-in-class, regulatory approved framework for delivering psychedelic-assisted psychotherapy. 

Clerkenwell CEO Tom McDonald and CSO Dr Henry Fisher spoke to Psychedelic Health about its plans to accelerate the development of efficacy data and help deliver psychedelic clinical trials at speed and scale.

Set and setting for optimal patient outcomes

Clerkenwell is setting up its Centre of Excellence in 2022,  which will be built with set and setting in mind – aiming to create beautiful spaces that will optimise outcomes for patients. 

McDonald commented: “There has been a bit of a shift over the past 15 to 20 years towards more speciality clinical research outfits and we think psychedelics, in particular, are really relevant for this. 

“Typically, trials at the moment – be they for oncology or viruses, or now, psychedelics and mental health – they are typically taking place in pretty unpleasant looking environments. So, out of the back of a university hospital is really the option that companies have got here in the UK at the moment. 

See also  Partnership to advance patient access to psychedelics in Europe

“We will be creating a really beautiful setting – more akin to the priory than a university hospital – out in a nice remote place. The rooms will be designed specifically to be conducive to a positive psychedelic experience that might therefore get incremental gains in the outcomes that the patients are going to receive.

“This is what is needed to drive the industry forward. We have also got an ambitious scale-up process that will go hand in hand with our partners’ drug development, as they are looking to increase the number of sites and then potentially increase the number of countries as well.”

Best-in-class psychedelic therapy training

Clerkenwell is working with The University of Manchester to design its own study exploring the therapy component of psilocybin depression treatment.

The team aims to build a best-in-class, accredited therapist training programme aligned with regulation, working closely with Dr Sara Tai, a senior lecturer in clinical psychology at the University of Manchester. Dr Tai, who previously helped design the therapist training programme for COMPASS Pathways, focuses her research on the similarities and differences between types of therapy. 

“We think there is a real uniqueness to psychedelics – unlike any other drugs really in the history of them, the talking therapy component is so important for the vast majority of these conditions,” said McDonald.

“So, by building expertise in understanding what therapy works, working across a range of different psychedelic compounds and a range of different conditions, we are going to be able to build a real best-in-class, therapist training programme that is closely aligned to what the regulators know and understand, and we will look to get that accredited by a serious body.

“There are still a lot of unknowns around the therapy component of these treatments, so we were looking to do some really interesting bits looking at depression – but specifically drilling into the therapy component and what digital therapeutics could be doing to help support the patient in addition to that.”

Fisher commented: “What we are very conscious of is the data on what types of therapy work and how the different types might benefit different people – interrogating how we can optimise the therapy for patients and optimise technology that sits alongside it to support the sustained efficacy of treatment. 

“I think one of the key things that may come out of some of the other trials that have been conducted is that it might be hugely effective in the short to medium-term, but actually if there is not ongoing support – just as with therapy without psychedelics – actually, depression can creep back in.”

Supporting the development of psychedelic care

Clerkenwell is currently working with Octarine Bio, which is which using yeast fermentation to produce psilocybin from sugar, to design clinical trials. 

“They’ve been working with the biosynthesis of various different compounds, they started with cannabinoids and now are looking to develop psilocybin as their first entity but potentially others down the line as well,” said McDonald. 

“We will provide everything from very early stage clinical advisory services, helping them design the study that they want to run, and then actually operationalising that when our site is ready in quarter two of next year. We are also likely to start engaging the regulators on their behalf in the not too distant future.”

In its partnership with Octarine, Clerkenwell has been epxloring conditions that have very poor treatment options available and identifying indications it believes psilocybin-assisted therapy is going to be beneficial for. 

“Octarine’s development is going to be more viable than the traditional lab development models, and also, when done at scale, is going to be considerably cheaper than others out there as well so, we are really hoping that helps with patient access – identifying a niche condition that has very poor treatment options and then providing a drug and this is associated therapy at a reasonable cost.

“When you start looking at the impact on quality of life or whether people are able to return to work and therefore get back into paying taxes, all of those downstream impacts are what we think is really interesting. Looking at some of those early-stage results where people are coming out after a single or two doses are at three months or potentially even six months are essentially symptom-free or heavily-reduced is where we think that there is real value.”

Fisher added: “The whole point of what we are trying to do is help companies that are want to bring these drugs to markets, build the data that is required to present to regulators, and do so in as an efficient and timely way as possible – being very conscious that either the current options either don’t have the correct facilities to be able to generate the best data. 

“Ultimately that will be the way that these drugs can get into patients hands as quickly as possible.

“I think something that Europe, but also the UK especially, has to their benefit here is that it has really strong research. Imperial College London and King’s College are world leaders in psychedelic research – since the start of the psychedelic renaissance. 

“That gives us a really strong basis on which to build collaborative research – there is a rich ecosystem of researchers that are keen to work with different people, and organisations that are just looking to push the whole sector forwards.

“We’re hoping to fit into that, where we can both work with the for-profit in the space and partner with other organisations and researchers, helping to deliver the trials that require input from different areas.”

Fisher, who started working in psychedelic research in 2015 at the Beckley Foundation, drug policy think tank, Volteface, The Loop, campaigning for drug reform, before founding Hanway Associates a cannabis sector advisory firm, continued: “It’s just wonderful to come full circle from where I started. I had a real passion for the potential of psychedelics years ago when it was only in the academic sphere. It didn’t look like this was anywhere near on the horizon. Now, it is very much reality. 

“It will be a paradigm shift when these drugs can actually be delivered to patients and it is very rewarding to be a part of that process.

“We are trying to focus on providing real gold standard, and paradigm-shifting care that we need to be doing in the trials to start with and then hoping that translates into real-world delivery. We are trying to help patients and get to the root cause, with the use of psychedelics in combination with therapy.”

Medicinal

Silo Pharma to utilise psilocybin for autoimmune diseases

The company has announced it is expanding its license agreement and patent portfolio.

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Silo Pharma to utilise psilocybin for autoimmune diseases

Silo Pharma has entered into a commercial evaluation license agreement (CELA) for next-gen liposomes therapeutics to target multiple diseases, including autoimmune disorders.

Silo Pharma has expanded its CELA with the University of Maryland Baltimore (UMB) for its next-generation liposomal peptide targeting autoimmune diseases.

CEO of Silo Pharma, Eric Weisblum, commented: “We are delighted to expand our partnership with UMB. Pre-clinical testing of these peptides has shown positive results in animal studies. 

“The three-phage peptides we identified specifically target inflamed vascular endothelium of arthritic joints in an adjuvant-induced arthritis rat model.”  

See also  Brain activity in depressed people increases following psilocybin use

Weisblum stated that to test the therapeutic effect of the peptides, arthritic Lewis rats (n=4/group) were injected intravenously with one of the peptides or PBS either at the onset or just following the onset of arthritis. 

“The rats were monitored regularly for disease severity and were assigned an “arthritic score.” The results show treatment of arthritic Lewis rats with two of the three phage-encoded peptides (NQR and RGD) suppresses adjuvant arthritis, with RGD producing the most robust effect,” he said.

“Therefore, phage peptides ADK homes to the synovial vasculature of the inflamed joint, while phage peptides NQR and RGD both home to this area of the inflamed joint and have a therapeutic effect in a rat model of arthritis.”

Silo Pharma’s drug – SPU-21, arthritogenic joint homing peptides utilising psilocybin – has demonstrated it significantly inhibited arthritic progression in the animal model, and the company is carrying out further studies at UMB.

It highlights on its website that the ability of the peptides to target inflamed epithelium suggest they could be used to target drug delivery. 

It notes that: “This approach could enhance the therapeutic effect of current and future therapies and decrease potential systemic toxicity despite systemic administration of the drug. These peptides have potential for the development of fusion imaging molecules and/or nanoparticles to study arthritic pathogenesis. 

“They could also be customizable and used to deliver nanoparticles for precise imaging. In addition, these novel joint-homing peptides can be used to treat autoimmune diseases, including but not limited to RA [rheumatoid arthritis].”

With the global market for autoimmune disease therapeutics projected to be over $150bn by 2025, Weisblum stated that the company believes the issued patent portfolio that comes with these assets allows Silo to further advance its value to investors and future partners.

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Research

Study to investigate macro and microdoses of psychedelic compounds

The study will interrogate how these doses modulate expression levels of molecular biomarkers of brain plasticity in rats.

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Study to investigate macro and microdoses of psychedelic compounds

Mindset Pharma and Canada’s top psychiatric research hospital, CAMH, have entered into a collaboration to build the molecular profile of MSP-1014 compared to psilocybin.

Under the collaboration, Mindset will sponsor a preclinical study at CAMH on its lead asset, MSP-1014. MSP-1014 is a novel and patented second-generation psilocybin-like compound that is being prepared for first-in-human studies alongside psilocybin.

Single psychedelic experiences can cause both short- and long-term behavioural changes in humans and the mechanisms of these are relatively under-explored. The study will interrogate how macro and microdoses of psychedelic compounds modulate expression levels of molecular biomarkers of brain plasticity in rats. 

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The team expects to uncover short- and long-term cFOS and BDNF expression changes that could underlie the long-term behavioural changes associated with a single psychedelic experience. 

It also expects to develop molecular insights into the magnitude of effects of its lead compound, MSP-1014, compared to psilocybin. 

CEO of Mindset, James Lanthier, commented: “Mindset’s drug discovery platform is built on a broad spectrum of high-quality scientific data generated in preclinical models. 

“This collaboration will profile and build our understanding of the observed superiority of our lead asset, MSP-1014, to psilocybin at the molecular level.”

Dr Anh Dzung Lê, senior scientist and Head of Neurobiology of Alcohol Lab in the Campbell Family Mental Health Research Institute at CAMH, will lead the study, supported by Dr Douglas Funk, a Project Scientist in the CAMH Neurobiology of Alcohol Lab. 

“We are excited to partner with Dr Lê and Dr Funk who are pioneers in mental health research to build this dataset and continue in our shared mission to advance groundbreaking new treatments to patients who are waiting,” said Lanthier.

“This study is the beginning of a strong partnership with CAMH, and we are excited for the research to come.”

“We are eager to work together with Mindset Pharma to contribute to the field of psychedelic knowledge. Given that by the time Canadians reach 40 years of age, 1 in 2 have – or have had – a mental illness, CAMH scientists and clinicians are dedicated to exploring treatment option that account for the unique needs of individual patients.

Dr Anh Dzung Lê commented: “We are pleased to partner with Mindset on this study as our missions are aligned in the prioritisation of mental health care.”

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Medicinal

Application submitted for trial exploring LSD analogue for migraines

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Application submitted for trial exploring LSD analogue for migraines

Ceruvia Lifesciences has submitted an FDA Investigational New Drug (IND) Application for its NYPRG-101 Migraine Prevention Program.

The company is aiming to begin a Phase 1 clinical trial of NYPRG-101, which is being developed for the prevention of migraines.

The trial would be a Phase 1, single center, randomised, double blind, placebo controlled, single ascending dose study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of NYPRG-101 (in healthy adult participants.

See also  Analysis finds clinical administration of LSD safe in healthy subjects 

NYPRG-101, also referred to in the literature as BOL-148, is a non-hallucinogenic analogue of LSD, differing by only one atom. 

First synthesised at Sandoz by Albert Hofmann in 1957, BOL-148 was used as a placebo in early LSD trials. BOL-148 has been administered to more than 150 humans (126 healthy volunteers and 28 patients) in clinical and experimental settings since the 1950s, with most of the research occurring prior to 1970. In these early studies, BOL-148 was observed to be non-hallucinogenic.

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Founder and CEO of Ceruvia Lifesciences, Carey Turnbull, commented: “This is another exciting milestone in the roll-out of our clinical drug development program and builds on our longstanding relationship with Harvard Medical School to investigate the use of BOL-148 to treat headache disorders.

“Migraine, which affects approximately 15 per cent of the population and disproportionately impacts women, is associated with significant psychosocial burden and disability. Results from our IND-enabling pre-clinical toxicology work as well as research conducted with human subjects prior to the 1970s, indicate a positive safety profile for NYPRG-101. 

“We believe that this molecule has great potential to provide meaningful relief to those suffering from migraine.”

This Phase 1 single ascending dose trial, to be held at a single clinical research site in the United States, will evaluate the safety, tolerability, pharmacokinetics and effects on neurocognitive functioning of healthy adult participants.

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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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