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UK scientists to research use of psilocybin in end-of-life support

The UK will now join countries such as the US and Australia to look at how psilocybin could form part of an end-of-life healthcare plan.

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UK scientists to research use of psilocybin in end-of-life support

UK scientists are to research the potential of psilocybin to boost the effects of talking therapies for people with an end-of-life diagnosis.

The team of scientists from the Kent-based research organisation Transpharmation will be aligning human and lab experiments to research psilocybin to help reduce depression for those with a terminal illness. The clinical trials will be led by London-based psychedelic research organisation Clerkenwell Health. 

The UK will now join countries such as the US and Australia to look at how psilocybin could form part of an end-of-life healthcare plan for people struggling emotionally with a terminal diagnosis. 

Clerkenwell Health CSO Henry Fisher said: “This partnership offers up a rare opportunity to deliver some truly joined-up thinking in terms of pre-clinical and clinical research. 

“Given the potential that psilocybin and related psychedelic compounds present as clinical tools across a range of indications, this is a hugely exciting development for advancing the clinical development process. This partnership will greatly assist companies in this space with accelerating their goal of market approval.”

Easing end-of-life anxiety

Research shows that between 25 per cent and 77 per cent of terminally ill patients have major depression and that 40 per cent of cancer patients develop significant distress on diagnosis,  including serious worry, panic attacks, depression and post-traumatic stress disorder (PTSD).

A double-blind trial of psilocybin use in cancer patients by researchers in the US demonstrated positive outcomes in mood, attitudes and behaviours in patients, which persist even months after a single dose administered in a controlled medical setting.

The Transpharmation and Clerkenwell study will further examine the use of psilocybin combined with talking therapies, which is posited to reduce end of life anxiety through fostering increased acceptance of their condition, and a sense of interconnectedness to the world around them. It is hoped that psilocybin will enhance the changes in perspective that are directed by talking therapy.

See also  Landmark psilocybin trial begins with dosing of patients

To remove the disparity between lab and clinical trials, the combined scientific team will work together on the design and implementation of the study, working from the same baseline so that observations in one sub-team can be quickly correlated or confirmed in the other.

Transpharmation’s Scientific Liaison Dr John Huxter said: “We have an opportunity here to align methodology across the clinical and preclinical work. 

“There have been some high-profile clinical trial failures in recent years, using treatments that nevertheless showed promise pre-clinically. In many cases, this is not because one result was right and the other wrong, but because the studies were not run in comparable ways. 

“Working in a joined-up fashion allows you to head off those problems in advance. For example, we can agree on desired tissue exposure, dosing regimen, the route of administration, and the kind of endpoints that we use. Then we have a much better chance of translating pre-clinical study success into positive outcomes for patients.”

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. 

See also  Microdosing: separating fact from fiction

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.

See also  Bicycle Day: where are we 80 years since the first LSD trip?

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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