🫠 This Week in Psychedelics

[5-min read] Cybin wins FDA's fifth psychedelic breakthrough therapy designation.

Welcome to Tricycle Day. The psychedelic news cycle is moving faster than ever. We’re pedaling our little hearts out to keep you up to speed, and we won’t stop until all three wheels fall off. 🫡 

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Here’s what we got this week.

  • Another week, another breakthrough therapy 🚀

  • VA gets a $20m psychedelic trial budget 🎖️ 

  • AI has a new favorite psychedelic 🦾

  • Euphoria is a spritz away 💦

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MICRODOSES
🔬 Research

Mechanism of action: Researchers at Hopkins and Imperial think they know why psilocybin works better than SSRIs for treating depression.
Plot twist: In a recent study, teenagers who used psychedelics were less likely to experience psychosis.
Be still, my heart: NIDA granted Gilgamesh Pharmaceuticals $14 million to develop a cardiac-safe version of ibogaine.
Deuty calls: Cybin is kicking off its Phase 2 study of deuterated DMT for anxiety.
Soul doctors: Every psychedelic therapy team needs a spiritual health practitioner, according to new research.

🏛️ Policy

Flora, fauna, funga: The National Geographic Society has expanded its definition of wildlife to include fungi, alongside plants and animals.
Mail-order Molly: A policy expert explains why you probably won’t be getting MDMA via telehealth, even after it’s approved.
Final push: Indiana and Utah have each sent psychedelic reform bills to the governor’s desk.
Task masters: The Maryland Senate has unanimously approved a bill to set up a psychedelics task force.
Edit undo: Kentucky’s new attorney general is asking the state’s opioid commission to drop its proposal to put $42 million toward ibogaine research.
*Gulp*: A Colorado bill would require social media platforms to ban users who talk about psychedelics.

📈 Business

O come, all ye faithful: America’s largest psychedelic church is hosting an Easter conference, complete with a non-denominational sermon.
Crypto consciousness: Are psychedelics and bitcoin two sides of the same coin?
Pay the taxman: The IRS has denied an ayahuasca church’s tax-exempt status.
Hustle Presence culture: Startup founders swear by microdosing.
Trial by fire: Harvard Law School is accepting applications for a three-day intensive Psychedelics Bootcamp.

🫠 Just for fun

The legacy market: What to know before you buy unregulated psychedelic products.
Turn on, tune in: DoubleBlind rounded up the best music for mushroom trips.
Meme of the week: When you trip sit for a friend

THE PEAK EXPERIENCE
You get a breakthrough therapy designation

Another breakthrough?

Cyclists, this is NOT normal.

Last week, we wrote about MindMed receiving the FDA’s fourth ever Breakthrough Therapy Designation (BTD) for a psychedelic drug.

Now less than a week later, the FDA has done it again. They’ve officially recognized that yet another psychedelic could offer meaningful improvement over the treatments available today.

The newest member of the club is Cybin’s “next-gen” psilocybin product, CYB003, for major depressive disorder (MDD). With the BTD secured, Cybin will get special access to the FDA, including accelerated reviews and advice on trial design.

Wait, hold up… Didn’t psilocybin already get named a breakthrough for MDD?

Good memory, dear reader. Your microdose must be working.

But there’s no reason the FDA can’t double down, especially on a disease as widespread and difficult to treat as depression. Besides, there are a few key differences between Usona’s and Cybin’s investigational drugs.

  • 🦠 The molecule: Usona used standard psilocybin. Cybin created a proprietary, deuterated form of the molecule, which in theory could improve absorption and patient outcomes.

  • 🧑‍⚕️ The psychotherapy: In both cases, trial participants got preparation and integration support from clinicians. But the approaches weren’t identical. Cybin has its own facilitation model, called EMBARK. (If interested, you can learn it for free.)

  • 📊 The results: It’s not fair (scientifically) to compare results across trials. But in Cybin’s study, 75% of participants were in full remission from depression after two 16mg doses of CYB003.

  • 🤑 The profit motive: Usona is a 501(c)(3) nonprofit. Cybin is publicly traded for-profit company. So, the two orgs may have very different plans for commercialization, post approval.

The way we see it, having more options is always better. So keep those breakthroughs coming, FDA, and please don’t break our spirits. 🫠

AFTERGLOW
wait, you guys are paying for own research?

Pay your own way, VA

One nice thing about being a US military veteran is that you might get free healthcare for life. Problem is, the VA would rather chuck a bunch of pills at vets than cover the cost of psychedelic therapy. Fortunately, changes may finally be coming. Now that President Biden has signed off on a new 2024 budget, the VA has $20 million to fund its own psychedelic clinical trials.

To be clear, this kind of research has been going on for some time. There are already at least 8 psychedelic therapy trials happening across the country through the VA. But so far, it’s all been philanthropically funded. With this law, Congress is pushing the VA to put some skin in the game. They’ll focus on MDMA and psilocybin to start.

Last December, the Department of Defense got authorization to study psychedelics in active-duty service members. Now, the vets are getting taken care of. That just leaves everyday civilians. So, uhh, which government agency would like to pick up the tab for the rest of us?

Aw-wee-oo, psychedelic tofu

When you spilled your guts on Reddit, I bet you didn’t think a biotech startup would use your trip report for their drug development program, did you? Alas, in the age of large language models, apparently anything goes. After analyzing 70,000+ trip reports with AI, Mindstate Design Labs has picked 5-MeO-MiPT, aka moxy, for its first research target.

Once you’ve shaken off the feeling of being watched, let’s talk about Mindstate’s approach. Basically, they built a machine learning platform to pore over forums, clinical data, and the dark web, so they could identify any substances that produced unique subjective effects. Their feeling was, the usual suspects—psilocybin, LSD, etc.—are all overplayed. If we want to treat different health conditions, we need different states of consciousness.

Ultimately, they landed on moxy because of its ability to mesh with co-administered drugs. Mindstate’s CEO calls it “psychedelic tofu.” As a first step, they’ll run a small Phase 1 study on moxy alone. Then, Mindstate will decide what to mix with it to design an entirely new psychedelic state. Call us crazy, but… may we suggest curry?

CYCLISTS’ PICKS
UNTIL NEXT TIME

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ONE CYCLIST’S REVIEW
Feeling euphoric

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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.

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