Psilocybin in Oz

Incannex (ASX:IHL) is pairing off with Monash University in Melbourne to launch psilocybin trials which will be the largest yet in Australia. 

Medical Cannabis to Medical Psychedelics 

Incannex is a licensed importer, exporter and distributor of medical cannabis products in Australia. Along with the cannabis products they have available for patients under the country’s Special Access Scheme, Incannex has four cannabinoid based products undergoing clinical trials. 

Brainy University

Monash is considered a “leading Australian University,” the trials will be conducted at the “Uni’s (as they say down under)” BrainPark a world class brain research facility. 

Power Couple: The trial will explore the use of psilocybin to treat generalised anxiety disorder. Together, Incannex and Monash will recruit 72 participants, some of whom will be given a synthetic psilocybin that will be produced as part of the research collaboration. 

Path Ahead

Incannex predicts the trial will take two years, after which they will take steps to gain approval from the US FDA. 

Aussies Considering Rescheduling Psychedelics

Also downunder, the charity Mind Medicine, not to be confused with the North American Mind Medicine Inc., is expecting good news from Australia’s Therapeutic Goods Administration. Mind Medicine submitted an application to the TGA to reschedule psilocybin and MDMA as Schedule 8 drugs. 

Schedule 8 drugs are controlled substances, meaning special rules apply for the production, distribution and possession of the drugs. The substance can only be prescribed by an authorized healthcare provider, who may need a special permit to do so. 

Prepping Ahead: Mind Medicine has already begun training therapists ahead of the anticipated decision. The charity’s January course, Certificate in Psychedelic-Assisted Therapies, is full with their second course in July “filling up quickly.”

Decision Expected Feb 3: If the TGA authorizes the rescheduling – a big if – Australia would become the first G20 country with widespread therapeutic access to psilocybin and MDMA. How widespread that actually ends up being would be dependent on other conditions that could be attached to the rescheduling. 

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Health Canada Approves Another Psilocybin Patient

Just before the end of 2020 another Canadian patient was approved by the Ministry of Health using the Section 56 exemption to use psilocybin. In this case the patient is Anthony White of Calgary, AB, who is dealing with “the severe mental health challenges that come with a terminal medical diagnosis.” 

More Advocacy

Now that a number of patients have been approved to use psilocybin in Canada, one more almost seems not newsworthy. What’s notable is that this patient was supported by a different non-profit group than the previous announced patients. In this case the Syntac Institute is responsible for the approval. 

Syntac is based in Calgary, AB, with the “mission to bring the healing and transformative power of psychedelic medicine and psychedelic-assisted therapy to Canadians.”

Outlook…Floodgates are opening. It’s only a matter of time before a permanent scheme is brought into place. 

Faking The Entourage Effect

Vancouver based psych firm Nova Mentis (CSE:NOVA) is attempting to recreate the entourage effect found in naturally occurring magic mushrooms. 

What is the entourage effect?

The entourage effect is the theory that a number of molecules in a naturally occurring substance work together to create the effect a user experiences. For example, in the case of cannabis it’s THC along with other cannabinoids and terpenes that create the “high.” 

Synthesizing The Ingredients

Nova Mentis works with an American contract partner to develop and manufacture synthetic psilocybin, they’ve added two new molecules to the pipeline:

  • Baeocystin is an analog of psilocybin and is found in most psilocybin mushrooms along with other minor tryptamine derivatives.
  • Aeruginascin is also a tryptamine derivative and an analog of psilocybin, but it occurs naturally within a different mushroom, Inocybe aeruginascens.

Why It Matters

Nova Mentis theorizes that the development of these other ingredients will form the basis to create technology which will allow these formulations to be used to target areas outside the brain such as the small intestine, colon and liver. 

It should be noted that by Nova Mentis’ own admission the research into this is extremely early. 

Mindset Expands Drug Candidates

Mindset Pharma (CSE:MSET) has filed a third provisional patent with the USPTO, bringing the total drug discovery candidates it has under review up to 50. 

Discovery Mindset: The company’s pre-clinical drug development program is developing “a broad portfolio of new psychedelic compounds,” with a focus on central nervous system indications. 

Moving Forward: 50 candidates are a lot to move forward with, Mindset plans to shortlist lead and backup compounds and take into studies by Q2 of 2021.

Report Read Out

Numinus (TSXV:NUMI) closes previously announced bought deal financing of $17 million. 

Ehave (OTC PINK:EHVVF) is selling its subsidiary Mycotopia Therapies to 20/20 Global Inc. (OTC PINK: TWGL) for $350,000 while simultaneously purchasing about 75% of 20/20 Global. 

Dr. Robin Carhart-Harris writes in Wired that “Big pharma is about to tune in to the potential of psychedelics.”

Vice proclaims 2020 the year of “the Magic Mushrooms”, exploring how the psychedelics got users through a very anxious year.