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World-first psilocybin trial for rare headaches initiated by Beckley Psytech

The phase 1b clinical tria has been approved by the UK Medicine and Healthcare Products Regulatory Agency (MHRA)

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World-first psilocybin trial for rare headaches initiated by Beckley Psytech

The first patient has received a dose of psilocybin in the world’s first trial investigating psilocybin as a treatment for a rare and debilitating headache disorder – SUNHA.

Initiated by Beckley Psytech, a private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, the trial aims to explore the potential therapeutic benefits of low-dose psilocybin for treating Short-lasting Unilateral Neuralgiform Headache Attacks (SUNHA).

The disorder is estimated to affect 40,000 patients in the US and Europe, and is typically diagnosed between the ages of 35 and 65. The condition is characterised by short-lasting, painful headaches that can occur over 100 times a day and there is currently no approved treatment for the condition.

World’s first SUNHA trial

The phase 1b clinical trial, which has been approved by the UK Medicine and Healthcare Products Regulatory Agency (MHRA), is being conducted as part of Beckley Psytech’s ongoing collaboration with the Psychedelic Trials Group, led by Dr James Rucker at King’s College London; Dr Manjit Matharu, Consultant Neurologist and Clinical Lead of the Headache Group at the National Hospital for Neurology and Neurosurgery; and Dr Giorgio Lambru, Consultant Neurologist at Guy’s & St Thomas’ NHS Foundation Trust.

See also  Beckley Psytech raises £58m for psychedelic medicine breakthroughs

CEO of Beckley Psytech, Cosmo Feilding Mellen, commented: “We are very excited to initiate this world-first clinical trial with Dr Matharu and Dr Lambru. This represents a significant milestone for Beckley Psytech and the patients for whom this product has the potential to benefit. 

“SUNHA is a severely debilitating disease which affects thousands of patients, and for which there is no currently approved treatment. The potential medical advantages of psychedelic agents, such as psilocybin, could be transformational to the quality of life for those affected by this disease. 

“Following on from our recent highly successful $80m funding round and MHRA approval for the upcoming 5-MeO-DMT phase 1 clinical trial, we are delighted to achieve this additional milestone.”

The study is a multi-dose, dose-escalation trial in patients suffering from five or more attacks over the last two weeks, to evaluate proof-of-concept efficacy by analysing the impact on frequency, duration and severity of headaches.

Enrolling up to 12 patients, the trial will assess the proof-of-concept efficacy of psilocybin and determine the maximum tolerated dose or recommended dose for further development. On day one, patients will receive dose one, on day six dose two, on day 11 dose three, with a follow-up visit on day 25.

“I have been involved with research into SUNHA for 22 years and have seen personally the devastating effect this condition can have on so many patients,” said Dr Manjit Matharu, Consultant Neurologist and Clinical Lead of the Headache Group at the National Hospital for Neurology and Neurosurgery. 

“I am delighted that Beckley Psytech is developing a truly novel approach which could lead to a safe and effective product for these patients with such a high unmet medical need. I look forward to investigating its safety and efficacy in this ascending dose clinical trial.”

The outcome of the phase 1b study, with proof-of-concept efficacy data, is expected in early 2022. 

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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