“Unprecedented Results” From Psilocybin Trial

Written By Alexander Boulden

Updated May 15, 2024

Dear Reader,

It’s been just over a month since my last update on psychedelic stocks.

Since then, there’s been a flurry of news, and just this week, a major development took place in the space.

One company in particular just released Phase 2 data showing that its psilocybin treatment beat out current FDA-approved treatments by a factor of 12.

That’s huge!

I’ll explain more about that in a minute…

But first, a bit of background.

“Our Epidemic of Loneliness and Isolation”

This entire psychedelics-as-medicine industry started gaining steam over the last few years as cases of depression significantly increased among our population here in the U.S.

For proof, the Surgeon General released a new advisory a few weeks ago called “Our Epidemic of Loneliness and Isolation.” Keep in mind that advisories are released when an issue poses an immediate threat to public health.

It’s no secret that we’re more isolated than ever. Even with our apparent technological connections through social media, we’re frighteningly alone. It all started way before COVID, but as with everything else, COVID accelerated the trend.

It was a perfect recipe for disaster once the pandemic hit. Isolate everyone, not just the vulnerable. Shut businesses down. Make us cover our faces and empower illogical thought bubbles to become the mainstream. Tell us lies. Confuse the populace. Cut us a check to shut us up.

Inflate the currency while the fat cats in Washington trade stocks and profited handsomely. Force us to vaccinate in the middle of a pandemic and prevent Big Pharma from getting sued if anything goes wrong… Censor those who don’t go along with the plan.

Foreign wars constantly raging…

We’re literally living in a dystopian world not unlike that of the novel 1984.

So yeah, you could say we’re depressed.

But back to the Surgeon General report… It found that people aged 15–24 were most at risk of being lonely, with physical consequences including increased risk of heart disease and stroke — and older adults are at increased risk of dementia.

Surgeon General Vivek Murthy spoke to NPR and said, “It’s hard to put a price tag, if you will, on the amount of human suffering that people are experiencing right now. In the last few decades, we’ve just lived through a dramatic pace of change. We move more, we change jobs more often, we are living with technology that has profoundly changed how we interact with each other and how we talk to each other.”

It’s not just the U.S., either.

The survivors of the Ukraine and Israel wars are going to suffer from severe PTSD and will need treatment.

So people are scrambling to fix their brains, essentially.

But the problem is there are only a few FDA-approved treatments for depression.

“Nothing Newsworthy or Controversial”

In the 1960s, there were two theories as to what causes depression. First, it was thought that it was caused by a lack of dopamine and norepinephrine. Second, it was believed that a lack of serotonin caused depression. By the 1990s, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) were introduced to the market because of their apparent effectiveness.

And now that’s become mainstream thinking.

However, a recent study found that depression isn’t caused by a serotonin or norepinephrine deficiency…

In the now-controversial July 2022 issue of Molecular Psychiatry, researchers wrote, “Our comprehensive review of the major strands of research on serotonin shows there is no convincing evidence that depression is associated with, or caused by, lower serotonin concentrations or activity.”

The media had a field day with the findings, and critics railed against the study, saying it didn’t come up with anything newsworthy or controversial. In fact, after the study came out, scientists and doctors said things like, “Of course there are multiple contributing factors to depression, not just a lack of serotonin.”

Whether that argument is true remains to be seen, because, as the study suggests, “80% or more of the general public now believe it is established that depression is caused by a ‘chemical imbalance.’ Many general practitioners also subscribe to this view and popular websites commonly cite the theory.”

What it sounds like is that no one really knows what causes depression… and Big Pharma figured it could make a ton of money by peddling its pseudo-science to the ailing public.

Well, while the pseudo-scientists try to figure it out the cause of depression (a fool’s game), psychedelics have actually been treating it.

Unprecedented Results”

So what’s the big news that I was talking about at the beginning of the missive before my long rant?

Ah, yes, a company I’ve mentioned before called Cybin (NYSE: CYBN) just released extremely impressive Phase 2 data for its proprietary drug CYB003, used to reduce major depressive disorder (MDD).

In a press release this week, Cybin’s proprietary deuterated psilocybin drug demonstrated a rapid, robust, and statistically significant reduction in symptoms of depression three weeks following a single 12 mg dose compared with a placebo.

The study’s results are statistically significant, but it gets even more impressive. In clinical trials, depression is typically measured using the Montgomery-Asberg Depression Rating Scale, or MADRS, for short.

Cybin notes, “The MADRS includes items ranging from sadness of mood, reduction in sleep and appetite, to difficulties in concentration, anhedonia, and negative and suicidal thoughts that are scored from 0–6 giving a total score ranging from 0 to 60. Typical score ranges for severity are: 0–6: normal; 7–19: mild; 20–34: moderate; and >34: severe depression.”

Cybin’s drug showed 14-point improvement on the scale, which researchers say is “unprecedented.”

The SSRIs that we talked about above — the FDA-approved depression drugs — only improved scores by an average of 1.82 points in clinical trials…

That means psychedelic treatment beats SSRIs by a factor of 12!

It’s exciting and encouraging news for investors who’ve believed in this industry all along.

The press release concludes with Cybin’s Chief Medical Officer Amir Inamdar saying, "Mental health disorders affect almost 1 billion people worldwide. Comorbid MDD occurs widely in medical and psychiatric disorders, including anxiety disorders and post-traumatic stress disorder. These interim results, together with emerging data from a number of academic studies, suggest that CYB003 may have therapeutic efficacy in range of mental health conditions."

This is just the first step, as psychedelics might hold the key to treating other diseases and disorders as well.

One thing’s for sure: The evidence is clear enough for me that I’m investing in this industry.

That's it for today, but make sure you check out the latest episode of the Angel Research Podcast.

There's been a lot going on around our offices lately, and our publisher and founder Brian Hicks sat down to discuss his latest project.

You see, for the last decade, Brian has been semi-retired… He's enjoyed traveling, living life to the fullest, and learning everything he can in the process.

But now Brian is seeing the tides shifting not only in the U.S. but on an international level, and he's decided it's time to teach people how they can become R.I.C.H.

Today he's announcing the R.I.C.H. Report, in which he'll show you how to live a long, happy, and healthy life in retirement. 

Stay frosty,

Alexander Boulden
Editor, Wealth Daily

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After Alexander’s passion for economics and investing drew him to one of the largest financial publishers in the world, where he rubbed elbows with former Chicago Board Options Exchange floor traders, Wall Street hedge fund managers, and International Monetary Fund analysts, he decided to take up the pen and guide others through this new age of investing.

Alexander is the investment director of Insider Stakeout — a weekly investment advisory service dedicated to tracking the smartest money on the planet so that his readers can achieve life-altering, market-beating returns. He also serves at the managing editor for R.I.C.H. Report, a comprehensive service that uses the highest-quality investment research and strategies that guides its members in growing their wealth on top of preserving it.

Check out his editor’s page here.

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