A psilocybin-based drug developed by the biotech company Psilera cleared a key milestone for human safety, the company announced last week. Psilocybin is an active ingredient in psychedelic, or “magic,” mushrooms, though this pharmaceutical version won’t make anyone trip.
The drug, called PSIL-006, could potentially treat frontotemporal dementia (FTD), the second most common form of early-onset dementia after Alzheimer’s disease. According to the Alzheimer’s Association, FTD affects up to 60,000 Americans at any given time. Currently, no FDA-approved treatment exists for FTD.
In its latest studies, Tampa-based Psilera found that PSIL-006 demonstrated a “strong” safety profile, suggesting it could be safe for human use. In models that mimic FTD, PSIL-006 improved memory, sleep, and learning. However, the FDA will need further studies (which could last for years) before greenlighting the drug, including extensive studies on living, breathing human patients.
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It’s that last part — testing in humans — where PSIL-006 may succeed where other psychedelic treatments have failed: in double-blind placebo testing. It’s also why Psilera designed PSIL-006 to lack psilocybin’s heady effects.
To review, double-blind placebo drug tests are the gold standard of FDA approvals. During a double-blind test, neither the researchers nor the patients know if a placebo or the actual drug has been administered. Double-blind measures minimize bias in the study.
However, psychedelic drugs such as MDMA (“molly” or “ecstasy”), LSD (“acid”), and psilocybin have been nearly impossible to study in a double-blind manner. That’s because placebos are usually inert sugar pills, meant to look like the real drug. Since psychedelics hit pretty damn hard, patients usually know when they’ve been given a placebo or the real deal — which completely ruins the goal of a double-blind study.
Since PSIL-006 won’t make anyone trip, patients in double-blind trials theoretically won’t know if they’ve been given a placebo or not, which is the entire point of a double-blind study.
Modifying the trip out of psilocybin comes with additional benefits, too. For instance, anyone with certain mental disorders or sensitivities to psilocybin, who can’t or won’t take shrooms, could benefit from PSIL-006. Additionally, dementia patients can become easily confused, increasing the chances of bad trips and lost therapeutic opportunities. (And no, dementia patients don’t need “challenging trips” to “do the work.” They need medication.)
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Making psilocybin and other psychedelics trip-free isn’t a new idea, although Psilera is among of the first companies to pull it off. For instance, Boston-based Onsero Therapeutics is developing non-psychedelic drugs that bind to the 5-HT2A receptor, the same receptor that binds MDMA, LSD, and psilocybin.
At Onsero, the goal isn’t to simply create a new molecule that can be patented. “A more selective agent, an agent that lacked the hallucinogenic effects, would be safer for self-administration at home and for chronic treatment,” Timothy Piser, chief scientific officer of Onsero, told Chemical & Engineering News. In other words, part of the goal is to move treatment out of supervised psychiatry clinics and into the convenience of the patient’s home.
Of course, the most obvious reason for making psychedelics non-trippy: It removes any and all anxiety surrounding a hallucinogenic experience. “Some patients are terrified when they go through these trips, and it’s not something they ever want to do again,” Aaron Koenig, chief medical officer at Boston’s Delix Therapeutics, another company investigating non-trippy drugs based on trippy compounds, said to Scientific American.
But do these trip-free psychedelics actually work? We won’t know for sure until the novel molecules clear their clinical trials. Regardless, the promise of psychedelic therapies — and their non-psychedelic derivatives — has blossomed into a multi-billion-dollar industry. And given the United States’ current mental health crisis, which currently affects about 60 million Americans, that billion-dollar promise isn’t going away any time soon.
