Psychedelic Bulletin: Australian Gov Earmarks $15m for Psychedelic Studies; Otsuka Licences R-ketamine in Japan; DC Initiative Becomes Law

Psychedelic Bulletin: Australian Gov Earmarks $15m for Psychedelic Studies; Otsuka Licences R-ketamine in Japan; DC Initiative Becomes Law

This week’s news stories remind us that the psychedelic renaissance is a truly global phenomenon. In Japan, pharmaceutical giant Otsuka has struck a deal with Atai Life Sciences’ Perception Neuroscience to commercialise the latter’s R-ketamine (PCN-101) for mood disorders.

In Australia, the federal government has earmarked $15m in grants to support psychedelic research, becoming one of only a handful of countries to directly support such work in a significant way. This comes after Australia’s medicine and therapeutic regulatory authority rejected calls to down-schedule psychedelics earlier this year, explaining that conclusive evidence on their safety and efficacy is not yet available. 

In the UK, meanwhile, Small Pharma’s DMT for depression trial was covered by the BBC with the tagline: A powerful hallucinogenic drug known for its part in shamanic rituals is being trialled as a potential cure for depression for the first time.

Psychedelic Sector News

Otsuka Partners with Perception Neuroscience to Commercialize R-ketamine for Depression in Japan

Pharmaceutical juggernaut Otsuka made waves this week with the announcement of a partnership with Atai Life Sciences’ Perception Neuroscience. The two companies announced a collaboration and licensing agreement for the development and commercialisation of Perception’s R-ketamine (PCN-101) in Japan. PCN-101 is a potential treatment for Major Depressive Disorder and Treatment-Resistant Depression, and potentially other mood disorders.

However, the eagle-eyed reader* will have noticed that Otsuka appears to have been interested in the underlying scientific research for some time.

Back when Jonathan Sporn – now CEO of Gilgamesh Pharmaceuticals – was leading Perception, the company licensed key patents from Professor Kenji Hashimoto of Chiba University in Japan. Hashimoto is one of the foremost academics in the ketamine-as-antidepressant field, and was an editor on a 2020 handbook on the topic.

It’s clear that Otsuka has been providing financial support to Hashimoto’s research (not all of which pertains exclusively to ketamine) for some time, with declarations of support made in papers as far back as 2015

While we can’t be sure where, exactly, Otsuka’s financial support to Hashimoto was used in practice, it’s clear that a relationship existed.

* and our eagle-eyed Editor-at-Large, Graham Pechenik

Merck Enlists Novamind Subsidiary to Run Trial Site

A couple of days after Perception’s Otsuka announcement, we caught wind of another ‘big pharma’ player entering the space. Or so it initially appeared.

Yesterday, Novamind shared a press release titled Novamind Partners with Merck for New Treatment-Resistant Depression Trial. The extent of the partnership is thus: Merck has selected Novamind subsidiary Cedar Clinical Research to act as a research site for one of its clinical trials.

The molecule under evaluation in this Phase II study is MK-1942, about which very little is known. There is no reason to believe this is a psychedelic molecule.

Cybin Completes 20th Preclinical Study

This week, Cybin announced that it has completed its 20th preclinical study, and is progressing two candidates – CYB003 and CYB004 into IND-enabling studies. The Toronto-based company has also initiated API manufacturing, via a contract manufacturing partner.

In Other News…

We can’t cover everything in this weekly bulletin. Here are a selection of other announcements made this week:

  • Bright Minds Biosciences claims its proprietary 5-HT2C agonist shows >50% decrease in opioid self-administration in rodent model
  • Algernon Pharmaceuticals submits pre-IND meeting request for DMT for stroke clinical research program
  • Pharmadrug begins DMT research activity in collaboration with the University of Michigan
  • Tryp Therapeutics files provisional patent for improved administration of psychedelics
  • Revive Therapeutics reports successful results for psilocybin for TBI

Financials, Financings and IPOs

A number of rounds closed this week, with Field Trip’s $95m raise taking pole position…

Field Trip Closes $95m Round

Field Trip has closed a $95m bought deal financing, marking the largest raise by a Canadian psychedelics company to date. Units were priced at $6.50 each, a significant premium on today’s spot price.

Numinus Closes $40m Round

After announcing a $30m round, then quickly upsizing to $35m, today Numinus announced the closing of its bought deal financing which ended up reaching $40m.

Bright Minds Biosciences Closes $25.9m Round

Bright Minds issued just over 3.4m units at a price of $7.57 each, for aggregate gross proceeds of around $26m.

Weekend Reading

Australian Government Earmarks $15m for Psychedelic Research

The Australian federal government has announced a $15m grant program to support research into psychedelics, including MDMA-assisted psychotherapy. This announcement comes just weeks after Australia’s medicine and therapeutic regulatory authority, the Therapeutic Goods Administration (TGA), rejected calls for reclassification of psychedelics. ABC News was among the mainstream media outlets that covered this development.

DC’s Initiative 81 Becomes Law: Effectively Decriminalizes Entheogenic Plants and Fungi

Washington, DC’s Initiative 81 has formally taken effect, effectively decriminalizing entheogenic plants and fungi by making them among the lowest law enforcement priority.

After a successful grassroots campaign to put Initiative 81 on the November 2020 ballot, the ballot measure passed with more than 76% percent support among DC voters. Initiative 81 was initially proposed by Melissa Lavasani, a DC mother of two who used plant medicines to overcome severe postpartum depression. 

The historic moment was covered in Newsweek, Washingtonian, NBC, and other mainstream outlets.

“Can Magic Mushrooms Heal Us?” – Ezra Klein for the New Yorker

In the latest high-profile article on psychedelics, Ezra Klein profiles Oregon’s progress toward delivering legal psilocybin-assisted therapy. Commenting on Measure 109, Klein writes:

What’s striking to me about Measure 109, though, is that it breaks away from the medicalization-legalization binary that has defined drug reform for the past few decades. It does not allow anyone to sell psilocybin pills in stores. Nor does it restrict treatment to those with a diagnosis of mental illness. The measure does not grudgingly accept psilocybin as the lesser evil compared with, say, the drug war or PTSD. Instead, it is based on the idea that psilocybin has the potential to change our lives for the good, whether we are sick or well, and so it is worth investing in the frameworks and safeguards so that it can be used safely and productively. 

BBC: Psychedelic Therapy Could ‘Reset’ Depressed Brain

The BBC covered Small Pharma’s DMT for depression clinical trial, the first of its kind. “It is hoped this could offer an alternative for the significant number of people who don’t respond to conventional pills for depression,” writes health reporter Rachel Schraer.

Stay Informed in 2021

We can only expect the rate of change and development in the psychedelic space to continue accelerating in 2021. Stay informed via our various platforms and channels…

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