Psyched: First Ayahuasca Pill Created, Psychedelics Legalization Predicted, UK's Research Support And More

Ayahuasca Pill Is Officially Here, Filament CEO Discusses Future Plans

The first medical-grade drug candidate of the psychedelic ayahuasca is being developed.

Currently, in the form of a pill, the compound was conceived by Vancouver, BC-based natural drug development company Filament Health FLHLF. 

Timing does seem appropriate, as psychedelics are becoming more of a conversation topic, and the development of a standardized version of ayahuasca is at an early stage.

Filament is trying to get FDA approval to begin the first Phase 1 clinical trial testing the novel drug, hopefully within the first half of 2023.

"Up until now, nobody had made natural versions of them, to a degree that they were standardized enough in order to do clinical studies," Filament founder and CEO Benjamin Lightburn explained. "Without clinical studies, it’s impossible to get good evidence for the safety and efficacy for the substances, because if everyone in the study is getting a highly variable, different product, then it’s really hard to draw good scientific or robust conclusions."

The issue of extreme variability is present when ayahuasca is administered in a traditional setting: “The amounts of plants that are extracted, the different species that are used, the strength of the extract… Different people in the same ceremony receive a highly variable amount of the psychoactive substances,” Lightburn explained.

Continue reading HERE.

Psychedelics Will Be Legal In Most U.S. States Within 15 Years, According To JAMA Analysis

A new analysis published in the Journal of American Medical Association (JAMA) holds that the majority of states will legalize psychedelics by 2034 to 2037. 

Led by researchers at Washington University in St. Louis, the study draws on a compilation and analysis of psychedelics legislation data introduced and enacted in cities and state legislatures as well as ballot initiatives held between 2019-2022.

More specifically, 69 legislative proposals and five ballot measures were considered between 2019-2022 across the country, out of which 10 bills were enacted while 32 remain active.

An interesting finding: most of the reform measures focused on psilocybin, while MDMA was the second most-mentioned psychedelic substance.

One point made by the study authors was that while psychedelics decriminalization is taking place in more liberal states, reform is advancing in a rapid “patchwork” manner across the U.S. and is becoming a bipartisan issue.

Further, they believe psychedelics reform in the US will also be impacted by key factors such as what the FDA decides in view of ongoing clinical trials and potential changes in the DEA’s scheduling.

The publication notes that state-level legislative reform has been “the primary driver” to cannabis legalization, as it became so in most states despite its Schedule I status and lack of FDA approval. 

Continue reading HERE.

UK Supports Psychedelic Research With Phase 3 Trial In Federal Health Sites

Awakn Life Sciences Corp. AWKNF has announced that its upcoming Phase 3 clinical trial assessing ketamine-assisted therapy for treating severe AUD will be delivered across seven National Health Service (NHS) sites in the UK. 

The trial will receive funding for 66% of total costs (forecasted at almost $2.8 million) by another UK government agency, the National Institute for Health and Care Research (NIHR.)  Awakn would invest slightly less than $1 million.

“For this Phase 3 to have the support and funding from the NIHR and for it to be delivered in the NHS is a great endorsement of this treatment’s potential and a sign of how badly a new more effective treatment is needed to help the millions of people suffering from alcohol addiction in the UK,” Awakn’s CEO Anthony Tennyson said.

Continue reading HERE.

The Milestone Round

Each week, we learn about new clinical trials, the creation of psychedelic-based compounds and novel potential treatments for those suffering from mental and physical health conditions.

The week has seen some interesting research being announced, including the launch of UCL’s new project assessing neuroplasticity induced by tryptamine psychedelics, the completion of a Phase 1 clinical study which could eventually lead to at-home psilocybin therapeutic use and the start of dosing on a Phase 1b trial studying the interaction between SSRIs and a DMT-based candidate. 

Notably, the FDA has granted two concessions to psychedelics companies, one related to the authorization of a new clinical trial assessing low-dose IV ketamine infusion in participants with Major Depressive Disorder, and another for the use of ketamine in the prevention of injury from organ transplantation.

Corporate news involved financing moves such as Mydecine MYCOF’s $2.5 million sale of wholly-owned subsidiary company and Psyence PSYGF and Revive Therapeutics RVVTF’ private placement announcements, and licensing deals such as Filament and Psyence’s one for palliative care.

Awakn Life Sciences posted its financial results for Q3 2022 showing substantial revenue, while Israeli Clearmind CMND detailed yearly research and clinical development to shareholders.

Other news comprised this week include the launch of a public accounting and advisory firm’s markets practice focused on cannabis, hemp, psychedelics, web3, and other enablement technologies, plus a statement by Uruguay’s Drug Board warning about the consumption of a pill with the 'EA Sports' logo causing serious intoxications and a presumed death.

Access the prior week’s roundup HERE.

Psychedelics EFTs Weekly Performance

This is how the sector’s major EFTs performed in the week spanning December 12-16.

• AdvisorShares Psychedelics PSIL opened Monday, Dec. 12 at $2.18, as compared to former week’s opening at $2.35 and Monday Nov. 28 opening at $2.26. That number steadily decreased during the week all down to $2.16 on Friday, Dec. 16, the former week’s almost same closing price. The highest point achieved in December so far corresponds to Friday 2, at $2.42.

The Elemental Advisors PSYK EFT PSYK opened Monday, Dec. 12 at $18.15, lower than Dec. 5’s $18.68 yet still higher than Nov. 28’s $17.95 and Nov. 21’s $17.62. Tuesday and Wednesday held almost that same figure, yet it dropped to low $17.48 on Thursday, Dec. 15 and finally closed at $17.46 on Friday 16, lower than prior Friday 9’s closing at $17.67, certainly lower than Dec. 2’s extraordinary closing at $19.15, and also lower than Nov. 25’s closing at $18.22. For this EFT, the yearly price range is set between $23.32 and $16.71.