Psyched: Detroit Decriminalizes Psychedelics, Compass To Study Psilocybin For PTSD, Filaments Gets First-Ever FDA Approval

Detroit Decriminalizes Psychedelics

Detroit is the latest to join the growing list of U.S. cities that have decriminalized psychedelic substances.

The measure under which the Motor City will “decriminalize to the fullest extent permitted under Michigan law the personal possession and therapeutic use of entheogenic plants by adults,” received approximately 62% votes in favor and 38% against, reported Marijuana Moment.

Under the new policy, “the personal possession and therapeutic use of entheogenic plants by adults” would be considered among Detroit’s “lowest law-enforcement priority.”

In October Seattle became the largest U.S. city to decriminalize psychedelic substances. Other cities that have decriminalized some or all entheogens include Oakland and Santa Cruz, California; Denver, Colorado and Ann Arbor, Michigan. 

California made headlines several times this year concerning its psychedelics decriminalization bill, which has already passed several committees.

Filament Health To Launch First U.S. Trial Using Plant-derived Psychedelics

Psychedelic drug discovery company Filament Health Corp. FLHLFFH obtained FDA approval to start the first ever clinical trial using naturally-sourced psychedelic substances in the U.S.  

The phase 1 trial has been designed to include 20 healthy subjects and will examine the effects of Filament’s three proprietary botanical drug candidates: PEX010 (oral psilocybin), PEX020 (oral psilocin) and PEX030 (sublingual psilocin).

“Our innovative technology has allowed us to create IP-protected botanical drug candidates of oral psilocin, sublingual psilocin, and oral psilocybin, and to enter them into an FDA-approved natural psychedelic clinical trial. Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation,” CEO Benjamin Lightburn said.

Compass To Launch Phase 2 Trial On Psilocybin For PTSD

Shares from Compass Pathways CMPS are soaring in anticipation of the data being created by the company’s phase 2 trial with psilocybin.

Adding to the excitement, Compass announced on Wednesday the launch of a new program using psilocybin in the treatment of post-traumatic stress disorder.

Compass is expected to release data from its depression study in the coming weeks. Anticipation for the announcement led the company’s stock to rise 55% in the last month, posting $49 per share at market close on Friday.

With this new announcement, the company is taking its proprietary version of synthetic psilocybin, COMP360, to 20 patients in a safety and tolerability study of psilocybin therapy for people who suffer from PTSD resulting from trauma experienced as adults.

The study will begin at The Institute of Psychiatry, Psychology & Neuroscience at King’s College London. Participants will receive a single 25mg dose of COMP360, given in conjunction with specialist psychological support.

“The primary endpoint of the study is to assess the safety of COMP360 psilocybin therapy. Secondary endpoints will measure efficacy in improving PTSD symptoms, functionality, and quality of life,” noted a company press release.

Bright Minds Biosciences To Join ‘Nasdaq Psychedelic Group’

Bright Minds Biosciences DRUG received approval on Wednesday to list its stock on the Nasdaq starting Monday, November 8 under the symbol “DRUG.”

The company is developing novel drugs for targeted treatment of neuropsychiatric disorders, epilepsy and pain by using psychedelics-derived molecules.

“With encouraging preclinical data across several indications, we are progressing toward first-in-human trials with our lead drug candidate, BMB-101, for the treatment of Dravet syndrome, a devastating congenital and genetic disease affecting the nervous system. We expect to commence the trials in the first half of 2022,” said Ian McDonald, CEO and co-founder of Bright Minds Biosciences. 

Bright Minds has a portfolio of next-generation serotonin agonists (compounds similar to LSD, psilocybin and DMT) designed to target neurocircuit abnormalities that are responsible for disorders such as resistant epilepsy, treatment-resistant depression, PTSD and pain.

Its lead drug candidate, BMB-101, has demonstrated compelling activity in in-vitro and in-vivo non-clinical tests, reported the company.

Cybin Gets DEA License To Work With Scheduled Psychedelic Molecules

Cybin Inc. CYBN has received a Schedule I manufacturing license from the U.S. Drug Enforcement Agency (DEA).

The DEA license is a federal requirement for any investigators intending to study, produce or analyze Schedule I substances. Before obtaining the license, Cybin conducted much of its R&D work through globally-licensed research organizations in the U.S., Canada, the U.K. and through certain in-house capabilities.

“With the DEA license, the company will be able to vastly expand its internal R&D capabilities to support innovative drug discovery and delivery involving Schedule I compounds,” the company announced in a press release.

“We are pleased with the progression of our clinical and regulatory efforts since the company's formation,” said CEO Doug Drysdale. "This new license further positions the company as a truly integrated biopharmaceutical company that can continue to work towards progressing psychedelics to therapeutics.”

The Milestone Round

PharmaTher Holdings Ltd. PHRM PHRRF has entered into a research collaboration agreement with Revive Therapeutics Ltd. RVVTF RVV to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle patch technology for neuropsychiatric disorders.

Tryp Therapeutics TRYPTRYPF has submitted an Investigational New Drug application to the FDA to evaluate its clinical candidate, TRP-8802, in a Phase 2a clinical trial that would investigate the safety and preliminary effectiveness of psilocybin-assisted therapy among patients with fibromyalgia in collaboration with the University of Michigan.
Nova Mentis Life Science Corp. NOVA NMLSF announced that the U.S. FDA has approved the company's  Orphan Drug Application for a proprietary version of psilocybin to treat patients with fragile X syndrome (FXS), the most common inherited cause of autism spectrum disorder.