Texas, California Push Psychedelics Forward

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October 7, 2022
6 min read

Following the efforts put forth by the likes of former governor Rick Perry, lawmakers in Texas have approved groundbreaking new psychedelics legislation.

House-passed bill will require the state of Texas to study the therapeutic potential of psychedelics like psilocybin and MDMA.
HB 1802 passed the Senate on Saturday with a solid 25-5 vote.
Once enacted, the state would be required to study the medical risks and benefits of psilocybin, MDMA and ketamine for military veterans.
It will also mandate a clinical trial into psilocybin for veterans with PTSD, in addition to a broader review of the scientific literature on all three substances.
Study will be carried out in partnership with Baylor College of Medicine and a military-focused medical center.

This bill is also joined by HB 2593 which will mark the first time Texas has reduced penalties associated with marijuana since the 1970s.

Bill to Decriminalize Possession and Use in California is Headed for Full Senate Vote

With a looming deadline, and after a rocky road to the Senate floor, a key vote pushes forward this new Senate Bill. Senator Wiener’s SB 519 to decriminalize psychedelics passed a key committee and will be voted on by the full Senate within the next 2 weeks.

It was approved by the Senate Appropriations Committee 5-2 on Thursday.
Bill would decriminalize possession of several psychedelic drugs for personal use and “social sharing.”
Includes LSD, ketamine, psilocybin, DMT, Ibogaine, mescaline, and MDMA.
Will set strict limits on possession, penalizing those under the age of 21 for using and possessing drugs on school property.
Possession of drug paraphernalia associated with psychedelics will no longer carry criminal penalties as long as they are owned by adults.
Those with prior criminal offenses for possession and use would have records expunged.

Senator Wiener wrote this bill to help end mass incarceration of individuals jailed for having non-seller quantities on them when arrested, as well as to increase scientific and medical testing to help those suffering from mental health conditions such as PTSD and depression. SB 519 is due to be voted on in the Senate by June 4th. If passed, it will then move on to an Assembly Committee.

Cybin’s Patents and Trials

Psychedelic drug development company Cybin (NEO:CYBN) has been approved to launch a phase 2 clinical trial on its sublingual formulation of psilocybin, for major depressive disorder (MDD). Ethics board at University of the West Indies Hospital in Jamaica granted approval this week.

The study will be conducted in two parts:

A Phase IIa study of 40 patients comparing the sublingual psilocybin formulation with a 25mg pill of psilocybin.

2. A randomized, placebo-controlled Phase IIb study, in 120 patients with major depressive disorder.

Cybin CEO Doug Drysdale said “There’s nothing else out there today that could enable you to remove a person’s depressive symptoms for potentially months at a time.”

Drysdale says Cybin plans to start human trials on three to four novel compounds later this year. This Phase 2 trial remains subject to final confirmation by Jamaica’s Ministry of Health.

And the patents keep chugging along

Cybin has filed for a 12^th patent, strengthening its portfolio of novel psychedelic molecules and delivery mechanisms with a provisional application for its drug candidate programs.

Application reveals innovative methods directed to promote decreased time for quicker onset (comparable to intravenous treatments) with decreased duration and side effects.
Patent directed to oral dosage forms with greater stability, better potency, more control over duration and greater bio-availability than other forms of these molecules.
Proposed method would greatly reduce the clinical costs by reducing clinical observation time.

With all of this promising progress by Cybin and their peers, there remains an uphill battle to gain approval by the FDA.

Big Cannabinoids Player Moves Into Psychedelics

Enveric Biosciences (NASDAQ: ENVB) has entered the final stage to acquire MagicMed in an all-stock transaction. They aim to improve standard of care and serve unmet needs across multiple indications including oncology and central nervous system (CNS) trauma.

Enveric’s current pipeline of naturally occurring compounds is focused on cannabinoids.
Drug discovery & development program will aim to treat cancer-related PTSD patients who are currently in treatment or in remission.
They will inherit MagicMed’s portfolio of molecules, their Psybrary™ of novel psychedelic derivatives, and 13 patent applications.
MagicMed’s state-of-the-art facility is located at the University of Calgary.

MagicMed’s patent applications include derivatives of psilocybin, DMT, mescaline, ibogaine and LSD. Their agreement with Enveric is expected to close during the second half of 2021. Upon closing, Dr. Joseph Tucker will be appointed Enveric Biosciences CEO and David Johnson as Executive Chairman.

PharmaTher Uses Leverage with FDA to Fight ALS

PharmaTher (CSE:PHRM) recently entered into an exclusive license agreement with The University of Kansas for the development & commercialization of ketamine in the treatment of ALS, also known as Lou Gehrig’s disease. They’ve now filed an application with the FDA to receive Orphan Drug Designation (ODD) for this method.

ALS affects 50,000 people in the US and Europe, with over 5,000 new cases annually.
It’s a progressive neuromuscular disease with a life expectancy of just 2 to 6 years after diagnosis. There’s currently no cure.
Patients experience progressive loss of voluntary muscle action, eventually resulting in the inability to speak, eat, move and breathe.
Pre-clinical research has shown that ketamine may increase life expectancy at any stage of the disease, and slow the degeneration.
PharmaTher is shooting for a potential phase 2 clinical study this year with ALS patients.

The company’s also conducting an FDA-approved phase 2 clinical study with ketamine to treat Parkinson’s disease, and developing a micro-needle patch for the intradermal delivery of psychedelics.