Psyched: British PM Considers Psychedelics, New Partnership To Study Psilocybin For Autism, Compass Gets Another Patent

The Week In Psychedelics

1. British Prime Minister Boris Johnson To Consider Psilocybin Legalization
2. Nova Mentis and Mycrodose Partner To Research Psilocybin For Autism
3. Fourth Massachusetts City Decriminalizes Psychedelics
4. Small Pharma Launched Phase 2 On DMT With Fast-Track Designation
5. Compass Receives New Patent From the USPTO
6. Ei.Ventures Reaches $20 Million With Reg A Raise
7. The Milestone Round

British Prime Minister Boris Johnson To Consider Psilocybin Legalization

Boris Johnson said he will look into the legalization of psilocybin after Parliament member Crispin Blunt urged Johnson to review a law allowing more research into the compound.

Johnson said he would get back to Blunt "as soon as possible," reported BBC News.

Blunt and co-campaigners are interested in moving psilocybin to Schedule 2 in the U.K. with some restrictions, including regulations to prevent inappropriate prescribing as well as to streamline medical and scientific research.

Placing psilocybin in Schedule 2 would put it in the same category as cannabis - 

legalized for medicinal use in 2018.

Blunt told BBC News the prime minister had privately given him an assurance last May that he was committed to rescheduling psilocybin for clinical research.

Nova Mentis and Mycrodose Partner To Research Psilocybin For Autism

Nova Mentis Life Science Corp. NOVA NMLSF and Mycrodose Therapeutics, entered a letter of intent to develop patented products to treat neuroinflammatory disorders.

The partnership plans to explore the use of psilocybin-based therapeutics in disorders like fragile X syndrome and autism spectrum disorder, by using Mycrodose’s patented drug delivery systems with Nova's proprietary version of psilocybin.

Dr. Marvin S. Hausman, chairman of Nova's Scientific Advisory Board, said that psilocybin has shown promising results in preclinical models of fragile X syndrome and autism spectrum disorder in sub-hallucinogenic doses tested in four preclinical trials.

“This collaboration with Mycrodose Therapeutics is a 'hand and glove fit' with our breakthrough psilocybin microdose discovery, as their advanced drug delivery technologies offer many advantages for microdosing drug delivery, including providing a non-invasive, sustained and controlled dose of medicine that can be self-administered," Hausman added.

Nova Mentis applied to the U.S. FDA and European Union for psilocybin Orphan Drug designation for fragile X syndrome treatment, which would provide a wide range of financial and regulatory benefits if granted.

The companies will create a new company of which they’ll become equal 50% shareholders, to develop R&D for the targeted indications.

Fourth Massachusetts City Decriminalizes Psychedelics

Last Wednesday, members of the Easthampton City Council passed a resolution that would decriminalize certain entheogenic substances and other drugs, Marijuana Moment reported, making it the fourth Massachusetts city to approve a psychedelics policy change.

Easthampton follows Cambridge, Sommerville and Northampton in decriminalizing hallucinogens such as psilocybin, ayahuasca and ibogaine, to name a few.

The measure, which passed in a 7-0 vote with two abstentions, was introduced by council member-at-large Owen Zaret.

Small Pharma Launched Phase 2 On DMT With Fast-Track Designation

Small Pharma Inc. DMT DMTTF has begun its phase 2a clinical trial on SPL026, a proprietary version of DMT.

The research is studying the application of DMT in association with psychotherapy for the treatment of major depressive disorder.

“The world’s first regulated clinical trial for DMT-assisted therapy targeting MDD is underway and we continue to make rapid progress. This is a key study for our DMT-assisted therapy portfolio as we assess the effectiveness of our lead candidate to treat MDD,” said Dr. Carol Routledge, chief medical and scientific officer of Small Pharma.

The company completed the phase 1 part of this research last month, which showed that the formulation had “a favorable safety profile with no serious adverse events.”

Now, the 42 patients taking part in the phase 2 proof-of-concept study have been given their first dose at two clinical trial sites in the UK. Topline results from the study are expected by the first half of next year.

The company also announced having received Innovation Passport Designation from the U.K. Medicines and Healthcare products Regulatory Agency.

“Similar to the FDA’s fast-track in the United States, the U.K.’s MHRA Innovation Passport provides us with access to specialist advice throughout the drug development process and has the potential to enable a speedier, more efficient development process for SPL026,” Routledge said.

Compass Receives New Patent From the USPTO

Compass Pathways CMPS has been granted its fourth patent by the US Patent and Trademark Office.

The company’s aggressive moating strategy towards patent use sparked a wave of public criticism towards the company last year, including comments from podcaster Tim Ferris, veteran psychedelics researcher Rick Doblin and Compass co-founder Christian Angermayer.

Compass’s new patent, granted on Tuesday, has composition claims to an alternative crystalline psilocybin, pharmaceutical formulations containing crystalline psilocybin and methods for treating major depressive disorder with the crystalline psilocybin.

“We are focused on developing the best therapies and bringing them to patients who are not helped by existing therapies in mental health care. With each new patent grant, the USPTO is recognizing our innovation, enabling us to continue to do the highest quality clinical research and to broaden our portfolio of evidence-based therapies for patients who urgently need better options,” said George Goldsmith, CEO and co-founder of Compass.

Ei.Ventures Reaches $20 Million With Reg A Raise

Emotional Intelligence Ventures, a company looking to develop a botanical approach to psychedelic medicines, announced that its Reg A has reached a milestone of $20 million.

The Hawaii-based company announced a $50 million public stock offering using the Reg A+ Framework in March. A Reg A+ offering allows retail investors and the general public (not just institutional and accredited investors) to take positions in the company before a public listing.

“I’m really passionate about democratizing investment opportunities so any investor can reap the rewards, and take all of the risks of early investment in game-changing companies,” said David Nikzad, founder and CEO of Ei.Ventures.

In August, the company announced a partnership with Tioga Research to develop a transdermal patch for sustained delivery of psilocin for mental health applications. Psilocin is the active ingredient in psilocybin mushrooms. 

The company also plans to launch a line of functional mushrooms, called “Mana Nutraceuticals,” in early 2022.

The Milestone Round

Field Trip Health Ltd. FTRP has opened its sixth clinic in the U.S., located in Seattle, as well as a new Canadian clinic, in Fredericton, New Brunswick.

Cybin CYBN has reached 74 preclinical in-vitro and in-vivo evaluations from its portfolio of novel proprietary psychedelic molecules.

Numinus NUMI has finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived Psilocybin extract.

Awakn Life Sciences Corp. AWKN AWKNF announced that its Bristol, UK clinic has received Care Quality Commission’s formal approval to begin treatments with Ketamine.