The Growing Non-Hallucinogenic Psychedelic Pipeline: Q&A with Joe Tucker, CEO of Enveric Biosciences

Joseph Tucker
CEO
Enveric Biosciences

One of the main factors holding back psychedelics from being more embraced by the life sciences industry as whole is due to the hallucinogenic side effects that come with the medications. However, the discovery of non-hallucinogenic psychedelics is bringing new life to the sector. Joe Tucker, CEO of Enveric Biosciences, spoke with Pharmaceutical Executive about this new type of psychedelic.

Pharmaceutical Executive: Can you discuss the state of the industry from the perspective of an emerging biotech?
Joseph Tucker: The sector that we are in is sometimes called the psychedelic sector, although I think that’s going to change. It’s very much an emerging space. What really triggered what’s going on in the space is a group of academics who spent time looking at the use of hallucinogenic agents for treating mental health indications. People started to see positive results, unlike anything that had been anticipated or seen for a very long time.

What we’ve seen over the past few years was an initial enthusiasm over taking something taboo and turning it mainstream. Two hundred companies were born out of thin air, probably 90 of them should not have been. As the scientists have caught up with the idea, the scientific understanding of what’s going on has become clearer. That’s created a second wave.

Now we’re seeing big biotechs and pharmas getting interested. They’ve recognized that a new mechanism is going on here and want to take a look at it. The biggest, most exciting thing that’s happening right now, is the non-psychedelic psychedelic. The idea is that you can actually eliminate that hallucination and still get the benefit, or maybe more benefit, because you don’t have that side effect.

PE: How would you describe your pipeline?
Tucker: Our most exciting drug candidate is the non-hallucinogenic that we created last year. We spent 2023 making a large number of molecules and asked them to do something that the dogma said couldn’t be done. They had to bind to a certain receptor to induce neuroplasticity without inducing hallucinations. It took us a year. The vast majority of molecules we made still caused hallucinations. We found one, and that is our most exciting molecule. We still have to go through the formal pre-clinical toxicology that’s required by FDA before we can start dosing humans. We have to dose a bunch of rats for a year.

The other program we have is actually a bit of an older program that actually does hallucinations. It’s meant to be an improvement to the psilocybin approach that’s out there that’s more advanced clinically. There are companies that have psilocybin in phase II and phase III type trials. We set out to make something that was better but still similarly. We could be testing that on humans by the middle of this year.

The non-hallucinogenic seems to have much more patient, regulator, and industry acceptance.

PE: How do tell if rats are hallucinating or not?
Tucker: The model that is used is called head-twitch response . When you give rodents a molecule that causes hallucinations in humans, they start shaking their head. They do this little twitch, like they’re trying to get something out of their head. You count the number of twitches. Everyone uses the same model.

PE: What are some of the struggles you’re facing developing these psychedelic treatments?
Tucker: There’s a few, some of which are not applicable to the non-hallucinogenic. One of the biggest challenges for those developing psychedelics that still cause hallucinations is the placebo effect. It’s well documented that the biggest predictor of whether you’re going to have a positive outcome to the clinical trial is whether or not the patient believes they were given a psychedelic agent. If they believe they got it, regardless of the truth, they do better. That’s a real problem because hallucinogenic agents are pretty obvious, so it’s a challenge when determining whether the molecule is working or not.

One of the other big challenges is the way that they’re currently envisioned for being delivered to patients. It’s going to require a controlled setting with a couple of healthcare workers, and this will actually be on the label. This causes limitations and requires patients to be in that setting for ten hours. It’s really not that mainstream.

When you have a non-hallucinogenic molecule, all of those go away. Patients in the study can’t actually tell whether they got the drug and they don’t need to be treated in an in-clinic setting. Those trials are going to be much more straight-forward and much less side-effect concerned with the side effect profile. We think there will be less commercialization concerns.

The side effect from the enthusiasm in the markets when the psychedelics arose, a lot of money was thrown into companies that maybe shouldn’t have been in the space. There was a huge, rising tide that lifted everyone at the same time the entire biotech sector was also rising. When the sector went down, the psychedelics went down harder than everyone else. There’s a real challenge right now because it seems like the sector went too far in the positive and then too far in the negative. There’s some good companies that are having a challenge raising the capital to do the job correctly.