Connect with us

Medicinal

Clinical trial application submitted for psilocybe medicine

Numinus Wellness has submitted the application for a Phase I trial.

Published

on

Clinical trial application submitted for psilocybe medicine

The application is for a clinical trial that intends to test the psilocybin extract for bioavailability and tolerability on 20 healthy volunteers.

Numinus Wellness has submitted an application to Health Canada for its Phase I study, HOPE, on its naturally derived psilocybe extract formulation, NBIO-01.

HOPE is a two-phase study that will take place at a Numinus’ clinic in Vancouver. The company intends to begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers, if approved.

Science officer and general manager at its Health Canada-licensed research facility, Numinus Bioscience, Sharan Sidhu, commented: “This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies.

See also  Global coalition launches to push for psilocybin rescheduling 

“The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development. 

“This natural product has been developed to be shelf stable, minimally variable and consistently meet label claims. The trial will not only assess safety but also give us data on comparative bioavailability.”

“At Numinus, we are focused on developing products and services in-house to ensure that high-quality standards are maintained,” added Payton Nyquvest, founder and CEO.

”I am very proud of the Numinus team – from our Bioscience experts who developed the product, to our clinical research team who will administer the study. 

“We look forward to achieving more milestones in our mission to make psychedelic-assisted therapies accessible to all who wish to safely use them.”

NBIO-01 is Numinus Bioscience’s first proprietary formulation developed from extracts generated using patent-pending technology. 

A patent was earlier submitted to the US Patent and Trade Office and announced on June 24, 2021. The formulation has been developed to stably deliver psilocybin and other synergistic compounds.

Medicinal

Silo Pharma to utilise psilocybin for autoimmune diseases

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

Published

on

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.

Continue Reading

Medicinal

Application submitted for trial exploring LSD analogue for migraines

Published

on

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.

Continue Reading

Medicinal

New plant medicine retreat series launched in Jamaica

Dimensions has launched ‘ASCEND’ – a series of psychedelic-assisted experiences.

Published

on

New plant medicine retreat series launched in Jamaica

Dimensions has launched its new international plant medicine retreat series in Jamaica.

The new ASCEND programme will combine legal plant medicine experiences with immersive luxury hospitality on the Good Hope Estate in Trelawny, Jamaica

Led by Dimensions’ chief clinical officer, Jesse Hanson, PhD, the ASCEND programme will span 11 weeks, including four weeks of preparation, one week of onsite practices and six weeks of post-retreat integration. 

This will ensure that participants maximise their transformational experiences, as well as have a clear plan and path to sustain their life improvements. 

Christopher Dawson, co-founder and CEO of Dimensions, commented: “We are relentless in the pursuit of our mission, which is Retreat, Reset, Transform. 

“The ASCEND program has been carefully designed by our expert teams to offer the very highest standards in self-betterment in pristine, natural environments to maximise our guests’ journeys to wellbeing, and ensure that participants receive personalised experiences that initiate lasting personal growth.”

Dimensions’ Chief Clinical Officer, Jesse Hanson, PhD, commented: “The launch of the Jamaica ASCEND retreats is an ideal complement to the retreat experience that we will be offering at our flagship Dimensions Algonquin Highlands location in Ontario, Canada, and future retreats that we are developing in Costa Rica and Mexico. 

“This a significant milestone as we continue to expand our diverse programming with a focus on the intersection of luxury hospitality, modern science, and plant medicine.”

The ASCEND program combines ancient practices with modern neuroscience while utilising the practices of poly-vagal theory with psychedelic medicine to deliver a uniquely integrated guest experience in an intimate and safe environment.

The Good Hope Estate is set on a 2000-acre historical property with hills, vales and a river running through its tropical landscape, underscoring Dimensions’ belief in the importance and role of nature in the healing experience. 

The first two retreat experiences will take place from Friday, 30 September to Friday, 7 October, 2022 and Saturday, 10 December to Saturday, 17 December, 2022.

Continue Reading

Trending

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.

Copyright © 2021 H&W Media Ltd.