🫠 This Week in Psychedelics

PRESENTED BY ALTHEA & FOUNDATIONS 🤝

Welcome to Tricycle Day. We’re the psychedelics newsletter that isn’t one to gossip… unless the mycelial network absolutely demands it. Your secrets are safe with us, though. Pinky swear. 🤐

Here’s what we got this week.

• Germany’s new psilocybin compassionate use program 🇩🇪

• AbbVie to buy Gilgamesh Pharmaceuticals for $1B 🤑

• How so-called “psychoplastogens” work 🧠

• Win a psychedelic trip to Antarctica 🇦🇶

FROM OUR SPONSORS

Psychedelics have been pigeon holed.

By that, we mean therapy and ceremony aren’t the only legitimate ways to work them.

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If you missed their live masterclass last week, you’re in luck. The encore replay is now available.

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MICRODOSES

🔬 Research

We’re trending: Hallucinogen use in the US has been steadily rising since 2021, according to an HHS national survey.
Your mileage may vary: Preclinical research suggests age and hormonal state affect one’s response to psilocybin.
Stroke of genius: Johns Hopkins has launched a study of psilocybin for chronic stroke.
Om my god: A brain imaging study found distinct neural mechanisms at play during psychedelic-enhanced meditation versus meditation alone.
I spy with my third eye: People who’ve had a visual experience on DMT are invited to participate in this online survey.

🏛️ Policy

The plot thickens: New details have surfaced about alleged finance violations in Massachusetts’ unsuccessful 2024 psychedelic ballot campaign.
Follow the leader: Arizona joined Texas as the second state to appropriate public funds for ibogaine clinical research.
HR would like a word: What does New Mexico’s Medical Psilocybin Act mean for the workplace?
Podcast tour of duty: VA Secretary Doug Collins boasted on air about the progress he’s made expanding veterans’ access to psychedelic therapy.
Keep calm and research on: The UK is loosening restrictions on research with Schedule I medicines, including psilocybin and MDMA.

📈 Business

A log of analogs: The nonprofit Portia Sophia launched an open-access chemical structure search tool to make psychedelic patent research easier.
Patent cliff jumping: The top 5 psychiatric drugs will soon go off patent. Two (biased) execs believe pharma companies will replace the lost revenue with psychedelics.
Shine bright: Diamond Therapeutics has begun enrollment in a Phase 2a clinical trial of microdosed psilocybin for anxiety.
Rise of the machines: 4AG Robotics raised $29 million to accelerate adoption of its autonomous mushroom harvesting technology.
Golden teachers: CU Denver is the first public university to launch a state-approved psilocybin facilitator training program.

🫠 Just for fun

Above the influence: High Times rounded up a list of psychedelic content creators shaping culture.
Underground atlas: Behold the first hi-res biodiversity maps of Earth’s mycorrhizal fungal ecosystems.
A flat circle: Learn how to alter the passage of time to feel faster or slower.
Meet your maker: What’s the difference between a DMT trip and a near-death experience?
Meme of the week: Day 1 vs Day 365 of being a psychedelic facilitator…

THE PEAK EXPERIENCE

A passion for compassion

We know, we know. Not everything is a competition.

But if there’s anything worth trying to be the best at, it’s compassion, right?

Well, if caring were a competition, Germany would’ve just lapped the field. The country's drug regulator just greenlit the EU's first compassionate use program for psilocybin.

This week, The Federal Institute for Drugs and Medical Devices (BfArM) authorized two facilities to treat adults with treatment-resistant depression using Filament Health's botanical psilocybin candidate, PEX010.

This makes Germany the first EU country to offer legal psychedelic access before full regulatory approval. Here’s what makes the German program unique.

• 🧑‍⚕️ Doctor’s choice: Licensed psychiatrists at the two sites can decide patient eligibility directly, without waiting for regulatory approval on each case.

• 🔄 Repeat dosing: They don’t have to get permission for additional treatments if the first dose doesn't work or to maintain benefits.

• 💸 Insurance coverage: The wraparound psychiatric care will be covered by health insurance, and Filament is providing the medicine for free.

• 💗 Potential expansion: Other sites can qualify to join, and LSD for generalized anxiety disorder could be added later.

Germany joins a small but growing club of countries offering pre-approval psychedelic access, alongside Switzerland, Canada, Australia, and New Zealand. But in each of those countries, approval decisions are made case-by-case, which creates administrative burdens that bottleneck the system. Not so in Germany.

Meanwhile, the US is still on the sidelines, at least at the federal level. (Shoutout Oregon and Colorado for going for it.) We have our Right to Try laws, which sound compassionate, but so far they’ve been a dead end for psychedelic access. And not for lack of effort.

Maybe we oughta show our American regulators more compassion. What goes around comes around, right? Right? 🫠

AFTERGLOW

Big Pharma Psychedelic

We love a good rumor, especially when it involves billion-dollar deals and psychoactive substances. Well, Bloomberg dropped a juicy one last week. AbbVie is reportedly in talks to acquire Gilgamesh Pharmaceuticals, a private psychedelic biotech, for $1B. Naturally, the news sent psychedelic stocks on their own little trip, with companies like Cybin, MindMed, and Compass Pathways posting gains of 3-10%.

You might remember that AbbVie invested $65 million in Gilgamesh last year. Well now, they’re apparently looking to scoop up the whole company. Here's the fun part. While AbbVie initially claimed to be interested only in non-hallucinogenic “neuroplastogens,” this deal would indicate otherwise. Gilgamesh's pipeline includes what many would consider true psychedelics, such as GM-2505 (bretisilocin) and GM-3009 (an ibogaine analog).

So is Big Pharma warming up to psychedelic medicine, visuals and all? Especially now that J&J's ketamine spray Spravato has crossed the $1 billion sales milestone, it’s hard to deny that the sector has matured. As one Jefferies analyst put it, this potential acquisition could prove that psychedelics are finally "an investable space"… which is Wall Street code for "we can make money off this now."

No trip, no problem

Speaking of non-hallucinogenic psychedelics, scientists just delivered some new intel on how these "psychoplastogens" actually work. (Neuroplastogen, psychoplastogen. Tomayto, tomahto.) Either way, it turns out the prevailing theory about psychedelic brain rewiring needed some updates.

UC Davis researchers compared 5-MeO-DMT with tabernanthalog (or TBG), a non-hallucinogenic analog of ibogaine that promises the brain benefits without the visionary journey. What shocked them was that both compounds work through the same neuroplasticity pathway, activating the serotonin 2A receptor and downstream proteins. The difference is their intensity. (Psychedelics are like turning a faucet wide open, while psychoplastogens let it drip.) But apparently a trickle is enough to rewire your brain.

Here’s where this research challenges the dogma. TBG promotes neuroplasticity without triggering glutamate bursts, which everyone assumed were essential to the process. And when researchers used lasers (sick) to zap away the new brain connections TBG created, the antidepressant effects disappeared. Together, this evidence suggests the hallucinations and therapeutic benefits of psychedelics may be separate phenomena after all. Big if true.

CYCLISTS’ PICKS

• 🚢 Sweepstakes: World explorers, here’s your chance to cross Antartica off the bucket list. Enter to win an all-expenses-paid expedition for two to see Rick Doblin, Paul Stamets, and more at Wonder Summit.

• 🏋 Mushroom protein: MUD/WTR, your favorite fungi-forward coffee substitute, launched a protein powder. It even comes with a mindfulness app. (Of course it does.) Take 15% off with code SUMMER.

• 🎧 Podcast: CNN’s One Thing ran a two-part series on “Psychedelics in the Trump Era.”

• 🤝 Virtual hangout: Psychedelic Professionals Networking Club is back this month with another meet-and-greet for people who’ve built their businesses around psychedelic medicine. Code TRICYCLE drops the registration fee to $5.

UNTIL NEXT TIME

That’s all for today, Cyclists! Whenever you’re ready, here’s how we can help.

ONE CYCLIST’S REVIEW

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DISCLAIMER: This newsletter is for educational and informational purposes only and is not intended as a substitute for professional medical advice. The use, possession, and distribution of psychedelic drugs are illegal in most countries and may result in criminal prosecution.