Psyched: Canada's Access To Psychedelic Medicines, Psilocybin No Cognitive Side Effects, Psilocybin Bill Washington

Canada Opens New Legal Pathways For Access To Treatment With Psilocybin And MDMA

In a groundbreaking decision, the Canadian government is changing the way patients can access psychedelic therapies with restricted drugs, including MDMA and psilocybin.

Through an amendment to federal regulations, Health Canada is now allowing physicians to request access to restricted drugs on behalf of patients through the Special Access Program (SAP), a program meant to streamline access to special treatments for patients with serious or life-threatening conditions in instances where other therapies have failed or are unsuitable.

While the official communication made sure to note that “this regulatory change will not result in large-scale authorization for access to restricted drugs,” the event can be seen as an official acknowledgment of MDMA and psilocybin’s therapeutic potential and eventually lead to further decriminalization measures.

New Bill Introduced In Washington State Would Legalize Psilocybin

Lawmakers in Washington State introduced a bill that would create a state-licensed program to provide medical treatment with psilocybin, the active compound in magic mushrooms.

The Psilocybin Wellness and Opportunity Act would legalize “supported psilocybin experiences” for adults 21 and older, who would be allowed to consume products containing psilocybin and psilocin, under the support of a trained and state-licensed service administrator, Marijuana Moment reported.

In October 2021, Seattle, the largest city in the state and northwest region, decriminalized the possession and personal use of natural psychedelic substances, launching a trend that is now expanding across the state.

As per the new bill, patients would be referred to a licensed service center and those with limiting medical conditions could qualify for psilocybin treatment at home.

MindMed Completes Phase 1 Clinical Trial Of Non-Hallucinogenic Proprietary Derivative Of Ibogaine

On Tuesday, Mind Medicine Inc. MNMD MMED completed its Phase 1 clinical trial of 18-MC, the company’s non-hallucinogenic proprietary derivative of ibogaine, being developed for the treatment of indications linked to opioid use disorder.

The New York-headquartered psychedelic-focused biotech company noted that the trial was completed in December 2021 with topline results expected in early 2022.

The reported Phase 1 single and multiple ascending dose trial, conducted at a clinical research site in Perth, Australia, examined the safety, tolerability, pharmacokinetics and effects on the cognitive activity of 18-MC in healthy volunteers. 

In preclinical efficacy models, 18-MC has demonstrated strong activity in reducing both withdrawal symptoms and self-administration of opioids, stimulants and other substances of abuse.

PsyMed Launches $25M Fund Looking At Psychedelics And Neurotechnology

PsyMed is an entrepreneur-led new $25 million venture fund with a focus on psychedelic medicine, precision psychiatry and neurotechnology. The fund’s goal is to support innovative solutions to solve today’s ongoing mental health crisis.

In 2020, founders Matias Serebrinsky, Greg Kubin and Dina Burkitbayeva began building a syndicate of partners called PsyMed Ventures that has so far invested $15.6 million in 14 companies. The syndicate, which now groups 300 investors, eventually mutated into PsyMed, an early-stage fund that invests in companies at the pre-seed, seed, and Series A rounds.

While the fund places a strong emphasis on the therapeutic potential of psychedelics, it also invests in other innovative areas of the biotech space. Serebrinsky said that diving into the psychedelics startup rabbit hole opened the group’s eyes to the immense opportunity available in adjacent markets like precision psychiatry and neurotechnology. 

“Psychedelics aren’t the only available solution. They won’t be able to help every single person in the world in their healing process. So with that in mind, other opportunities are also worth exploring. We’re looking to expand beyond a type of fanaticism that’s pervasive in the psychedelics space,” Serebrinsky said.

Psilocybin Does Not Produce Adverse Effects On Cognition Or Emotional Function, New Compass Study Finds

A new study is shedding light on the safety profile of psilocybin.

Published on Tuesday in the Journal of Psychopharmacology, the study looks at the effects of psilocybin in the cognitive and emotional functions of healthy volunteers. While psilocybin is known for its ability to reduce depression in the long term, its effects on cognitive function remain understudied.

The research was undertaken using COMP360, a proprietary version of psilocybin developed by Compass Pathways CMPS. 

Conducted at King’s College London in 2019, the study looked at the effects of two doses of COMP360 psilocybin compared with placebo in 89 healthy male and female adult volunteers. Participants received either a 10mg dose, a 25mg dose or a placebo. 

There were no serious adverse events and COMP360 psilocybin was found to be well-tolerated with no clinically-relevant negative effects on cognitive function.

Filament Health Approved To Start Phase 2 Trial On Psilocybin

Filament Health Corp. FLHLF FH announced that Health Canada has approved a phase 2 clinical trial which will use the company's standardized natural psilocybin drug candidate PEX010.

The trial will study the safety and efficacy of low doses of psilocybin in healthy subjects with persistent depressive disorder. The placebo-controlled phase 2 trial is expected to begin dosing in the first quarter of 2022 and has been designed to include 100 healthy subjects experiencing symptoms of persistent depressive disorder.