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World’s first DMT-assisted therapy trial successfully completes first phase

The trial demonstrated the intravenous formulation of DMT to be safe and well-tolerated in psychedelic naïve volunteers.

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World’s first DMT-assisted therapy trial successfully completes first phase

The successful completion of Phase I of the world’s first clinical trial investigating the use of DMT-assisted therapy could lay the foundation for a “new paradigm” in the treatment of major depressive disorder.

The placebo-controlled trial demonstrated the intravenous formulation of N,N-dimethyltryptamine (DMT) – a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals – to be safe and well-tolerated in psychedelic naïve volunteers with no serious adverse events reported.

Carried out by neurpharmaceutical company Small Pharma, Phase I of the trial has now been completed and Phase IIa has begun, using a combination of psychotherapy and Small Pharma’s lead candidate, SPL026, for the treatment of major depressive disorder (MDD).

Emerging scientific evidence suggests DMT could have rapid-acting and long-lasting antidepressant effects. The command’s short psychedelic experience of less than 30 minutes could enable short treatment sessions and the potential for convenient supervised treatments within patient clinics.

Small Pharma CEO, Peter Rands, said: “We are delighted to have made such swift and excellent progress in the seven months since starting Phase I. The successful completion of Phase I means we can now truly assess SPL026 as a new potential treatment option for patients with MDD. 

“There has been little innovation for patients suffering from MDD in the last few decades and SPL026 has the potential to change the mental health treatment landscape and provide a much-needed alternative therapy for patients.”

Dr Carol Routledge, Chief Medical and Scientific Officer of Small Pharma added: “We have achieved a significant milestone in the development of SPL026. With a strong safety and tolerability profile, now demonstrated, we can move ahead with the first regulated clinical trial of DMT-assisted therapy in patients. 

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“These results lay the foundation for Small Pharma’s DMT-assisted therapy as a potential new paradigm in the treatment of MDD.”

The dose-escalating Phase I study administered SPL026 in combination with supportive psychotherapy to 32 healthy volunteers who had no previous experience with psychedelics. 

Small Pharma say it has generated a robust dataset on the pharmacokinetics of SPL026 – which elicits a breakthrough psychedelic experience – using Good Laboratory Practices as well as on safety and tolerability.

Phase IIa of the study, which is being held at two UK clinical trial sites, Hammersmith Medicines Research and MAC Clinical Research, will involve in 42 patients with MDD and will assess the efficacy of one versus two doses in combination with psychotherapy.

Small Pharma is advancing a pipeline of DMT-based therapies and is leading the clinical trial in collaboration with Imperial College London.

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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