Tryp Targets Patent In Bid To Battle Binge Eating Disorder With Psilocybin

Deep-rooted psychological factors are often at the core of eating disorders, and psilocybin is showing promise. As treatment advances, Tryp Therapeutics developed psilocybin-based compounds that could bypass the problems of dosage, and filed for a new provisional patent for the use of psilocybin in treating Binge Eating disorder (BED).

Among all eating disorders, BED is among the ones that prove most challenging to treat with conventional medicine, and one of the disorders that’s probably most tied to psychological factors. Patients with BED scored “significantly lower than controls in physical well-being autonomy, environmental mastery, and self-acceptance scales,” researchers found in a 2014 study. It affects as many as 3.5% of females and 2% of males at some point in their lives.

And that’s where the true extent of psilocybin’s potential in treatment comes to play: Tryp’s Phase II Study of the Treatment of Overeating utilizing Psilocybin (STOP) trial, in collaboration with the University of Florida, represents the first use of psilocybin in conjunction with psychotherapy as A therapeutic intervention in patients with BED, announced on June 9. The initial data readout for the first patient dosed in the STOP trial shows potential benefits.

Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) is focused on psilocybin-based treatments, and examining approaches to treating everything from phantom limb pain to hypothalamic obesity. Eating disorders make up a new territory.

“Binge eating disorder is where there’s a compulsion around food or an addiction to food,” says Jim Gilligan, Chief Science Officer and Interim CEO of Tryp Therapeutics. “Where people sit down and eat with the best intent, they’ll just eat 6-7000 calories at a sitting. And then they’ll feel badly about it. But this is a continuum. And so it’s really if you think about it, just sort of a compulsion to food and inability to limit food intake.”

Meanwhile, traditional approaches for people with disorders like BED might involve a drastic solution like gastric bypass surgery. “But what we found is that even individuals who have surgery within four years or so start gaining all the weight back,” Gilligan says. “Why? Because their behavior hasn’t changed. So they’ve done something to limit the amount of calories or how much they can consume, but the drive to continue to eat is maintained. And so we really felt that this behavior change, it will be key to the success.

“So what the strategy we’ve adopted at Tryp is that we’ve decided to go after areas distinct from other companies, from our peer, so that we’ve looked at what’s hyperphagia, overeating, binge eating, and we’re looking at different types of pain which are characterized as nociplastic pain—sounds really fancy. It’s a great word. You love throwing around, you know, cocktail parties, but no: nociplastic pain is pain that originates in the brain. And the best example I always use is phantom limb, because if someone loses an extremity, you still have pain there. That obviously has to be cut from the brain.”

Tryp Therapeutics Compounds

In early stage trials, Tryp is focusing on TRP-8802 to evaluate the use of psilocybin-related compounds in certain neuropsychiatric disorders. Furthermore, the plan is to study Tryp’s lead drug candidate TRP-8803, currently in development, in subsequent trials.

“So the approach that we’ve taken is we’re using what’s called TRP-8802, which is sort of standard oral psilocybin,” Gilligan says. “And we use that really as a tool to see whether or not it’s going to work. So we administer that obviously in conjunction with psychotherapy similar to other clinical trials. And well, once we see whether or not we get the expected results, then we’ll transition to what we call TRP-8803, which is our proprietary product. And the rationale for that is right now, the FDA allows us to use TRP-8802. We’re working on getting approval to use TRP-8803. So at a certain point, we can transition from what we started with to our proprietary product.”

TRP-8803’s formulation and delivery system and is specifically designed to enhance the positive effects of psilocybin and psilocybin-related compounds, while markedly reducing the limitations of other routes of administration—including oral, nasal, and sublingual delivery routes.

Addiction can come in the form of eating disorders, while it may not be the first thing that comes to mind.

“If you look at what’s being done at [Johns] Hopkins, you know, you have alcohol addiction, nicotine addiction. Now, people are looking at opioid addiction,” says Gilligan. “If you think about this situation, it could be sort of an addiction towards food. So there is a common denominator there. And what we want to do is give the therapists an opportunity to get deeper into the subconscious and to allow access to these neural networks that are responsible. And that’s that’s sort of the rationale behind it now. And there are a number of scientific papers that are published. But until you actually go out and perform this study, you don’t know.”

Researchers involved in Tryp Therapeutics’ study in Florida will examine patients, with no placebo, and all subjects are given a psilocybin-based formula. They will see if they can detect a measurable change, and so far—that’s what they’re seeing.

“What we elected to do in order to get a jump start and we want to be first-movers, you want to be the first and it be seen over, you won’t be the first in nociplastic pain. And so we knew that the FDA was comfortable with orally administered psilocybin and we worked with you saw an institute to source that from New Zealand and they’ve been very supportive and people doing clinical research on psilocybin. So our 8802 is basically a 25-minute capsule containing synthetic or oral psilocybin.”

The Problems of Dosage

When you’re dealing with a compound like psilocybin, there’s a relatively fine line between a clinical microdose and a bad trip.

“One of the things that they observed along with one of their scientific advisors Robin Carhart-Harris is a bit of his frustration with orally administered psilocybin is that you could have, say, a young woman who weighs 60 or 70 kilos, take the capsule , and after an hour or so staring out like it’s just all that happens, there could be someone, you know, my size of 100 kilos who takes the same capsule and has a very even a psychotic trip—a bad trip.”

The team learned that the blood levels were extremely variable. So determining doses based on kilograms alone isn’t even a reliable metric for titration. Psilocybin itself does not have any inherent biologic activity, because it has to be converted in the body. Factors like these make dosage a complex challenge.

“So 8803 will achieve a target, much more accurate blood models,” Gilligan says. “They’ll enter the psychedelic state within, say, a half hour. And we’ll change we can control the duration to be optimal, whether it be an hour or two. So basically we just wanted to correct the deficiencies that were identified with oral and we think it will give better efficacy because we know that people get the right dose. It’ll be safer because the side effects with psilocybin are so similar to high blood levels and it’s going to be more patient- and doctor-friendly because you’re going to reduce the time by, you know, a lot, 75%.

Gilligan has worked in the biotech industry for over 35 years and has had a number of patents under his belt. He says the most important thing when when you apply for a provisional patent is that you must have the requisite data within a year’s period of time to support the claims. He added that if you really want to know what the formula is, you’ll have to wait for the patent, which should be published in September.

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