Psyched: Four New States With Reform Bills, Psilocybin For Genetic Disorders And Functional Neurological Disorder, Struggle For Access & More

Psychedelics States Reform: Utah, Iowa, Missouri and Oklahoma’s New Bills; Hawaii, Arizona and Washington's Green Lights, New Hampshire's Setback

Earlier this week, three bills were introduced and added to the list of measures calling for some sort of psychedelics legalization, while some of the already filed ones continue progressing and others get a thumbs down.

• Utah: Legislators want to legalize psilocybin therapy for adults over 21 within a clinical setting and a proven diagnosis of depression, treatment-resistant anxiety, PTSD or currently at hospice care; Iowa representatives aim to remove psilocybin and psilocin from the state’s list of controlled substances
• Missouri: This bill promotes research into the therapeutic potential of psilocybin, MDMA and ketamine for the treatment of PTSD, TRD, substance use disorder and end-of-life care Learn more about Hawaii, Arizona and New Hampshire’s proposals HERE. 
• Oklahoma: The Sooner State saw the relaunch of a 2022 proposal involving psychedelics. Last year, HB 3414 was amended but ultimately killed. However, sponsor Rep. Daniel Pae (R-Lawton) is once again leading the effort of legalizing and promoting clinical trials and research on the impact of psilocybin and psilocin for certain mental health conditions. The new HB 2107, first read on Monday, Feb. 6, would enable universities and research facilities to conduct clinical trials on psilocybin and psilocin to treat PTSD, depression, anxiety, OCD, TBI, early-stage dementia, opioid use disorder and chronic pain. In the same state, Democratic Rep. Mickey Dollens is sponsoring a measure to prevent fentanyl overdose deaths through the decriminalized use of fentanyl testing strips.
• Washington. There's a bipartisan effort for legal psychedelic therapy for citizens 21 and older. The Psilocybin Services Wellness and Opportunity Act has faced the Senate Committee on Labor & Commerce where first a hearing was held (Jan. 30) and finally passed by a majority on Thursday, Feb. 16. The original text has been amended, and the new SB 5263 version has been referred to the Senate Committee on Means and Ways. 
• The new SB 5236 intends to establish a board, as well as an interagency work group, “to provide advice and recommendations on developing a comprehensive regulatory framework for access to regulated psilocybin for Washington residents who are at least 21 years of age.” Learn more about Oklahoma’s proposals and what has remained of Washington’s measure HERE.

Psilocybin: Exemption For Phase 2 Trial On Genetic Disorder, Works On Functional Neurological Disorder, Claims For Compassionate Access 

Wellbeing Digital KONEF subsidiary KGK Sciences will advance with the first-ever Phase 2a clinical trial assessing repetitive, oral microdose psilocybin therapy for Fragile X Syndrome (FXS), a genetic disorder.

KGK and its client Nova Mentis NMLSF are set to conduct this pioneering clinical trial to study the effects of take-home microdose psilocybin on the cognitive and behavioral symptoms associated with FXS.

Wellbeing Digital received an exemption under Section 56 of the Canadian Controlled Drugs and Substances Act (CDSA). KGK will lead the trial and use Nova’s recently completed production of API cGMP synthetic psilocybin 1.5mg microdose capsules. More on the Phase 2 study HERE.

Meanwhile, King’s College London is set to conduct a new study on psilocybin’s efficacy on “psychiatry's blind spot;” that is, the new open-label trial will assess the effects of a single psilocybin dose of 25 milligrams on subjects with a diagnosis of the common and disabling Functional Neurological Disorder (FND).

The National Institutes of Health (NIH) defines this condition as “a group of common neurological movement disorders caused by an abnormality in how the brain functions” with two primary categories: psychogenic nonepileptic seizures, and functional movement disorder.

Austrian neurologist Sigmund Freud named it “conversion disorder” because he believed it was originally a psychological disorder turned into a neurological one.

While FND gives the brain no significant structural damage, it makes it momentarily unable to function normally: it cannot send and receive signals properly, thus affecting the function of the lobes, emotional processing and potentially memory, concentration, cognition and the processing of sensations. 

More on KCL’s novel study HERE.

Last, Ontario-based Red Light Holland Corp. TRUFF has committed to becoming an aligned supporter and advocate with the non-profit TheraPsil towards advancing a charter challenge relating to the prohibition of psilocybin under the Controlled Drugs and Substances Act (CDSA).

The claim is that the prohibition of psilocybin under the CDSA constitutes a violation of Section 7 of Canada's Charter of Rights and Freedoms, that is, patients’ right of life, liberty and security.

Red Light Holland will offer financial support of up to CA$10,000. CEO Todd Shapiro says the company is proud to partner and provide financial support to TheraPsil in trying to change the laws to provide all Canadian adults who need it with legal access to psilocybin. 

The organization has been encouraging the government to work with patients, healthcare professionals and industry on medical regulations for the past three years, with “fruitless” results so far according to Hawkswell.

“We want to work with the government to find a solution to the cruel treatment of palliative Canadians who are seeking medical access to psilocybin to treat their end-of-life distress and mental illness,” he said. “Many seek psilocybin as a treatment for their anxiety, depression, and pain. Some see it as an alternative to Medical Assistance in Dying (MAiD), while others find it helps with the process. If we have the right to die, we should have the right to try psilocybin.”

More on TheraPsil’s charter challenge 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.

Lots of updates:

• Reunion REUN’s and Cybin CYBN’s reported quarterly earnings and expenditures
• Awakn AWKNF’s, Irwin IWINF’s and Numinus NUMIF’ new sites in Europe and U.S.
• Clearmind aims to patent a novel combination of a cannabis-like compound with classical psychedelics in the U.S.
• Filament FLHLF and PharmAla have signed supply deals to provide partners with psilocybin and MDMA.
• Other partnerships have been inked to propel drug development pipeline and sales.
• As for studies, both Small Pharma DMTTF’s intravenous vs. intramuscular study and Algernon AGNPF’s prolonged infusion trial use proprietary DMT compounds. Plus, a potentially disruptive study has learned why psychoplastogens might allow brain networks to grow while SSRIs cannot.
• Last, a Canadian-based company is aiming to produce cocaine and heroin for harm-reduction purposes, amid a dealer’s license amendment.
• Miscellaneous stories this week include a review on the link between psychedelics and schizophrenia, specialized attorney Adriana Kertzer and TV host John Oliver’s takes on psychedelics, JP Gaultier And Haider Ackermann on magic mushrooms, lovers & fashion, and sync-ing weed, shrooms and astrology.

See also: Last Week's Edition Of 'Psyched'

Psychedelics EFTs Weekly Performance

This is how the sector’s major EFTs performed in the week spanning February 13-17.

• AdvisorShares Psychedelics PSIL opened Monday 13 at $2.15, considerably lower than prior week’s opening at $2.30 yet still within last weeks’ openings’ oscillation ($2.16, $2.23 and $2.29.) After rising Tuesday 14 to $2.22, it finally stabilized and closed Friday 17 at $2.18, almost the same as past week’s closing.
  For this EFT, the yearly price range was once between $6.26 and $1.82, after gradual changes in the last months was set between $5.00 and $1.79, and is now again redefined to highest $4.57 and lowest $1.79

• The Elemental Advisors PSYK EFT PSYK opened Monday 13 at $18.15, lower than prior opening at $18.40 and yet higher than two weeks’ past opening at $17.99. Week’s highest was $18.22 on Tuesday 14, lowest was achieved on Thursday 16 at $17.80, and it finally recovered to close on Friday 17 at $18.10.
  For this EFT, the yearly price range was set between $23.32 and $16.70, and now the lowest price has been adjusted to $16.28.

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