🫠 This Week in Psychedelics

Welcome to Tricycle Day. Depression sucks! We’re the newsletter that wants you and everyone you know to be happy, healthy, and mentally free.

Here’s what we got this week.

• Psilocybin for major depression 🍄

• California decrim bill moves forward 📜

• Psychedelic biotechs get acquired 🤝

• A beauty line with a far-out mission 🧖

FROM OUR SPONSORS

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Luckily, Synthesis Institute has pulled together an expert panel to discuss these very challenges on September 19.

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RESEARCH

Major breakthrough in major depression

It’s getting harder to keep a straight face when you say psilocybin isn’t a miracle drug.

Yet another clinical trial has shown its impressive potential to treat depression. In this latest study, just one 25mg capsule with psychological support was enough to ease depression for weeks.

In fact, the trial participants who took psilocybin got relief from their depressive symptoms after just eight days. And by the six-week mark, about half were still responding to that single dose. No serious side effects were reported.

It’s important to remember we can’t compare results across trials (that’s bad science). But we can point out a few reasons why this study is special.

• 💥 Breakthrough therapy: The FDA granted breakthrough therapy designation to Usona Institute, the study’s sponsor, for psilocybin in 2019. Only one other company (COMPASS Pathways) has received the same vote of confidence.

• 🧑‍⚕️ Broader indication: Major depressive disorder (MDD) affects over 17 million people in the US. Many other psilocybin research programs, including COMPASS’s, are focused on treatment-resistant depression (TRD), which affects only 2.8 million Americans.

• 💊 Active placebo: “Blinding” psychedelic trials has always been a challenge because, you know, it’s pretty obvious when you’re tripping. This time, half the trial participants got a B vitamin pill, which can produce a similar flushing effect to psilocybin. (Not sure if anyone’s fooled though…)

• 🔬 Non-profit sponsor: The Usona Institute is not a pharma company. So it’s not entirely clear what will happen if their psilocybin program is approved. (Will they license it? Spin off a subsidiary? Distribute it non-commercially?  

There are a lot of people who could benefit from this, so here’s us shooting our shot.

MICRODOSES

💡 A new paradigm: Two respected psychedelic researchers argue that psychedelics require a complete rethinking of mental health care delivery.

🧑‍💻 Let’s circle back on this one: A new study proposes occupational exposure limits for psilocybin, in the hopes of reducing hazards in the workplace.

🥼 I’ll try anything once: A recent poll found that over one-third of people under 50 were interested in participating in a psychedelic clinical trial.

❌ Unbreakable X: Nova Mentis has started screening participants for its Phase 2a trial of psilocybin for Fragile X Syndrome, the leading genetic cause of autism.

POLICY

California decrim bill gets more amendments

When Tupac sang, “California knows how to party,” I’m not sure if this is what he had in mind.

This week, all eyez are on me Sen. Scott Wiener and his psychedelic decriminalization bill, SB-58, which just cleared the California Assembly’s Appropriations Committee with amendments.

Now, getting this far in the legislative process is a big deal in itself, but let’s be clear. It ain’t over ‘til it’s over.

Case in point: an earlier attempt by Senator Wiener to decriminalize psychedelics in California was gutted by the same Assembly committee in August 2022. It was ultimately withdrawn.

Looks like they were pretty heavy handed this time around, too. Major amendments to the bill include:

• 📆 Delaying implementation (legalization) until January 2025

• 🧑‍⚕️ Cutting out facilitated and supported use

• ⚖️ Halving the allowable amounts for personal possession

• 🍠 Striking ibogaine from the list of natural psychedelics covered

Next, the bill goes to the Assembly floor for one last vote before heading to Governor Gavin Newsom to either sign into law or veto. 🤞😬

Let’s hope Newsom’s presidential aspirations don’t cloud his judgment if/when the bill crosses his desk. May we offer you a little microdose to improve cognition, hmm?

MICRODOSES

🌺 Lei it on the line: Hawaii’s new psychedelics task force has held its first meeting to plan for legalization.

🧐 Show me the money: Oregon’s legal psilocybin program is still being funded by taxpayers, even though law backers promised it’d be covered with fees by now.

📞 Tell us how you really feel: Colorado officials are holding public listening sessions as a step toward implementing legal, regulated psychedelic healing centers in the state.

🥱 Same here: An influential group of MPs are calling for psychedelics to be rescheduled in the UK to support clinical research.

👔 The conservative case: Former Texas Governor Rick Perry explains why he thinks psychedelic medicine should be legal and which substance he’d most like to try.

BUSINESS

It’s M&A szn, psychonauts

If you can’t beat ‘em, join ‘em, they say. And of course by “they,” we mean the investment bankers cashing in on 8-figure mergers and acquisitions.

This week, two major deals were announced. And both of them are game changers for the psychedelic industry.

• ✅ “Big pharma” company Otsuka is buying Mindset Pharma, a psychedelic biotech, for $59 million cash.

• ✅ Psychedelic biotech Cybin is acquiring its competitor Small Pharma in an all-share transaction.

The Mindset acquisition matters because it signals that the big boys are taking psychedelics seriously. With MAPS expected to clinch the first psychedelic FDA approval within a year, we could see other pharma juggernauts follow Otsuka into the arena, too. (FYI, this is often a necessary step before a drug can be brought to market.)

The Cybin-Small Pharma merger is important because it creates the largest IP portfolio in the psychedelic drug development sector. Together, the combined company holds 28 granted patents with 158 more pending.

We’re always happy to see collaboration toward a more psychedelic-friendly and mentally well world. Apropos of nothing, if anyone is feeling inspired to acquire Tricycle Day for $59 million, we’re only an email away. Just sayin. 👀

MICRODOSES

🫵 Anotha one: Silo Wellness, a psilocybin retreat business, will acquire Kaya Herbhouse, Jamaica’s first medical cannabis dispensary.

♥️ Moral imperative: Reset Pharma has licensed Filament Health’s botanical psilocybin for a clinical trial on demoralization syndrome.

📈 One comma club: Journey Clinical has onboarded over 1,000 providers to deliver ketamine-assisted psychotherapy across the US.

🧑‍🏫 Continuing education: MAPS is releasing nearly 300 recorded sessions from its conference, Psychedelic Science 2023, under a pay-what-you-can model.

EYEahuasca — Marie Claire’s beauty team and 7 board-certified dermatologists tested hundreds of products, and this eye cream from A.P. CHEM came out on top. The best part? The psychedelic SKUs aren’t just a trippy brand choice. This company has partnered with The Ketamine Fund to provide free ketamine treatment to veterans suffering from PTSD. Get 15% off any of their products with code TRICYCLE15.

Wonderland — Missed PS2023? Dodged the floods at Burning Man? The next global event in psychedelics, mental health, and longevity is Wonderland, and it’s going down November 9-11 in Miami. We interviewed the president of Microdose, who’s throwing the conference, and he tossed us a special discount to share with the Cyclists. Use code TRICYCLEDAY20 for 20% off any ticket.

Out-Of-Pocket Newsletter — We found our (somewhat) more straight-laced cousin. If you want to understand where the broader healthcare ecosystem is headed, subscribe to Out-Of-Pocket. You’ll get plain-English breakdowns of healthcare news and trends. And just like Tricycle Day, there will be memes.

That’s all for today. Before you head off, don’t forget to share, rate, and review Tricycle Day below. Catch ya next time, Cyclists! ✌️

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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.