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Application submitted for trial exploring LSD analogue for migraines



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.

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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.


Canada’s SAP patients to receive Blue Serenity psilocybin



Canada’s SAP patients to receive Blue Serenity psilocybin

Optimi Health has launched Blue Serenity – Canada’s first natural therapeutic psilocybin product, in collaboration with psilocybin patient advocate Thomas Hartle.

Once approved by health authorities under Canada’s Special Access Program (SAP) or an authorized clinical trial, patients, doctors, and researchers will receive Blue Serenity in blister packs of eight psilocybin capsules.

Blue Serenity is standardised to contain a total of 25 milligrams of natural psilocybin in the form of EU-GMP biomass grown as Panaeolus cyanescens mushrooms cultivated at Optimi Labs Inc. in Princeton, British Columbia. 

See also  Brain activity in depressed people increases following psilocybin use

Optimi’s Chief Science Officer, Justin Kirkland, and Head of Cultivation, Todd Henderson, collaborated with Hartle to breed a specific genetic strain based on Hartle’s previous therapeutic experiences.

Optimi CEO, Bill Ciprick, commented: “Anyone who has entered the psychedelics space in the last two years will tell you that Thomas Hartle’s story of compassion and kindness inspired them in some way to want to make a difference.

“We are tremendously excited to be partnering with Thomas to become the first Canadian company to launch a natural psilocybin product specifically to help patients seeking relief through the Special Access Program.”

Proceeds from the sale of Blue Serenity will directly benefit psilocybin patients through Hartle’s new charity, a venture that will provide access to psilocybin therapy for underserved adults. 

Optimi will also make a $5,000 monetary donation to the charity in commemoration of the two-year anniversary of Hartle’s Health Canada approval to undergo psilocybin-assisted therapy.

Ciprick said: “It’s an excellent opportunity for Optimi to give back to those in need, while helping to build a network of trust between business, advocacy, patients, and doctors, that we hope will further the framework for compliant access and increase the overall confidence of practitioners in this medicine.”

Optimi Health has explained that Hartle’s choice of the name “Blue Serenity” touches on the emotional and visual aspect of his psilocybin experience, specifically in how he was able to redefine the inner sense of peace his therapy brought him.

Hartle said: “Blue Serenity was born from an experience that took me from a state of extreme anxiety to a feeling of calm that I never knew existed.

“Knowing that my journey will live on in a natural substance that others will be able to access goes to the core of everything that is right about psychedelic therapy, and that in itself is an incredibly moving experience for me.”

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Project Solace: world’s largest medical psilocybin access and data project launches

The project will be led by Canadian non-profit TheraPsil in conjunction with UK non-profit Drug Science. 



Project Solace medical psilocybin access and data project launches

In a move that aims to provide patients in Canada with the “life-changing opportunity” to receive psilocybin-assisted psychotherapy, TheraPsil and Drug Science are collaborating to launch ‘Project Solace’.

Project Solace is a medical psilocybin access and data project aiming to inform the development of regulated psilocybin therapy. The project will be working to expand legal access to medical psilocybin for patients in Canada, and collect evidence documenting psilocybin-assisted psychotherapy.

Using a real-world data registry, the non-profit organisations will be collaborating to collect anonymised data through Project Solace. The data will be provided to regulatory bodies, including Health Canada, to facilitate decision-making surrounding the regulatory system for the future of medicalised psilocybin.

Access to psilocybin-assisted psychotherapy in Canada is currently only authorised through Canada’s Special Access Program (SAP) in emergency situations. The SAP is Health Canada’s preferred pathway, outside of clinical trials, for patients in medical need to access legal psilocybin-assisted psychotherapy and psilocybin for medical purposes. 

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TheraPsil, which is dedicated to advocating for patients in medical need of psilocybin and psilocybin-assisted psychotherapy, and Drug Science, an independent scientific body on drugs in the UK, emphasise that the SAP is inaccessible to many patients, as:

  • The SAP is limited to emergency situations where other treatments have been tried and failed. 
  • Accessing the SAP requires working through layers of bureaucracy and puts unfettered discretion in the hands of the government. 
  • Healthcare professionals who are proficient in psilocybin-assisted psychotherapy, and carry the confidence to request this treatment option, are few and far between.

Professor of Neuropsychopharmacology at Imperial College London and founder and chair of Drug Science, David Nutt, stated: “The Canadian Special Access Program has the potential to provide thousands of Canadian patients with a life-changing opportunity to receive psilocybin-assisted psychotherapy from a team of trained medical professionals. 

“The clinical trial procedure is not an appropriate process for many patients due to the severity of the conditions that psilocybin-assisted psychotherapy attends to treat. Project Solace will be the largest database of prescribed psilocybin in the world and real-world data gathering helps us to understand how these drugs are affecting patients.” 

See also  Patient approved to receive psilocybin therapy for MDD

A patient who has been able to access a psilocybin-based medical product with TheraPsil’s support, Thomas Hartle, commented: “Getting access to this proven treatment through the SAP is bittersweet for me. I am grateful to receive the treatment. 

“However, the vast majority of Canadians who need this therapy do  not have access to the level of professional support that TheraPsil provided to me, and that played such a great role in my SAP application being approved.”

Aims of the project

The project aims to expand legal access to psilocybin medicine for patients in Canada suffering from conditions such as end-of-life distress, Major Depressive Disorder and other serious conditions, which have failed to respond to traditional treatment options. 

It also aims to develop a substantial body of evidence, using a real-world data registry, to document clinical effectiveness, safety and clinician and patient reported outcomes in patients who have received psilocybin-assisted psychotherapy through Canada’s Special Access Program (the SAP), or, under exemptions authorizing possession of psilocybin.

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Through Project Solace, TheraPsil will support prescribing healthcare practitioners in Canada to feel confident and capable to request psilocybin-based medical products on behalf of their patients through the SAP. 

As part of ensuring patient safety and treatment efficacy, TheraPsil will also identify and connect prescribing healthcare professionals with trained treatment therapy teams across Canada that will support patients in medical need through the facilitation of psilocybin-assisted psychotherapy. 

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Director of research at TheraPsil, Julia Joyes, Msc, highlighted: “The SAP represents a giant leap forward in our healthcare system, allowing unprecedented early access to medications that are clearly on the path to full Health Canada approval. 

“This expanded access also presents an invaluable opportunity to collect real-world data on the  use of psychedelic medicine in clinical practice. 

“We should certainly cherish this opportunity.”

TheraPsil will help patients connect to prescribing healthcare professionals who can request cGMP psilocybin from licensed dealers enrolled in Project Solace – including HAVN Life Sciences, Filament Health and Psygen.

Project Solace plans to begin assisting patients in five primary regions in British Columbia, Ontario and Quebec, and plans to expand as additional treatment teams are onboarded.

The data will be released to licensed dealers enrolled in Project Solace and the general public. 

Patients who consent to participate in Project Solace will complete standard healthcare questions at various points in their psilocybin-therapy journey.

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IND application submitted for psilocybin alcohol use disorder programme

B.More has submitted the application.



IND application submitted for psilocybin alcohol use disorder programme

B.More has submitted an Investigational New Drug (IND) application for its Psilocybin Alcohol Use Disorder Programme.

According to the US Centers for Disease Control and Prevention, excessive alcohol use kills roughly 95,000 Americans each year and is the leading cause of preventable death.  

In addition to increased risk of chronic disease and death, excessive alcohol use can negatively impact memory, learning and mental health and carries massive economic and social costs.

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B.More is a non-profit, clinical-stage biopharmaceutical company focused on the development of psychedelic medicines for substance abuse disorders. Founded in 2017 by Carey and Claudia Turnbull, B.More is named after Claudia Turnbull’s brother, Brett Moore, who died of a drug overdose 50 years ago

The company has submitted the application to begin a Phase 2b trial to determine the efficacy and safety of synthetic psilocybin (SYNP-101) in treating alcohol use disorder (AUD).  

The trial, which will be initiated in early 2023, will be led by principal investigator Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine.

Co-founder and CEO of B.More, Carey Turnbull, commented: “B.More’s psilocybin AUD program IND application is a major step forward in our mission to develop psychedelic medicines for individuals struggling with alcohol use disorder.  

“Our Phase 2b trial builds on the impressive work led by Dr Bogenschutz and will provide vital data to further advance our drug development programme.”

B.More’s Phase 2b, multicentre, randomised, double-blind, active placebo-controlled clinical trial will assess the 24-week efficacy and safety of synthetic psilocybin (SYNP-101) in treating moderate to severe alcohol use disorder (AUD).  

With a planned 226 participants, it will be the second largest psychedelics clinical trial ever conducted.

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