ELE-101 – Beckley Psytech’s IV formulation of psilocin


IV formulation of psilocin

At the end of last year, Beckley Psytech announced the acquisition of life science company Eleusis. The procurement was largely based on the potential of ELE-101, Eleusis’ IV formulation of psilocin, which the team believes may have a shorter treatment duration and less variability compared with oral forms of psilocybin.

Members of Eleusis’ management team were subsequently integrated into the organisation’s C-suite, with Senior Vice President Rob Conley transitioning into Beckley Psytech’s Chief Scientific Officer.

Rob Conley brings to the table a wealth of drug development experience, having previously served as Chief Scientific Officer for Neuroscience at Eli Lilly. To discuss the potential of ELE-101 to treat major depressive disorder cost-effectively, PSYCH spoke with Beckley Psytech’s new CSO.

‘ELE-101 is a benzoate salt of psilocin,’ explained Conley. ‘Specifically, it is psilocin benzoate we have a patent for developing as a powder, which can be dissolved and given as an IV solution. 

‘Psilocin is the pharmacologically active metabolite of psilocybin, but it is unstable. It is degraded by light, heat and water, so it doesn’t last very long, and that is why the benzoate salt is very important to provide stability prior to injection. 

‘We have a lot of data from both oral and IV psilocybin administrations that demonstrate that this agent produces a psychedelic effect. It also appears that these psychedelic experiences have effects on conditions like depression, which is what we are studying. 

‘What we are looking at, and what fits into the overall Beckley Psytech strategy, is if this IV preparation delivers a safe and short psychedelic experience and whether that is enough of an experience to provide a therapeutic effect. 

‘Our plan is to investigate this treatment in people with depressive disorders as soon as we can, whether they are on background therapies like SSRIs or not. We are part way through Phase I trials right now, and that ascending dose study will be completed very soon. 

‘We have explored with regulatory agencies the idea that we could include people on SSRIs, and they are very open to that. In the real world, most people with chronic depression are on antidepressants. Not everyone is, but most of them are, so to have a therapy you can implement alongside those  is beneficial. 

‘Ultimately, we would like to have both people on SSRIs and people not on SSRIs in the study. What we have seen so far from the literature is that there doesn’t seem to be any reason to worry about adjunct safety, but understandably the FDA and other regulators have their concerns. This is why it is important to show that there aren’t any problems, and that is what our studies will be focused on showing.’

To minimise the resources required to administer psychedelic-assisted therapies, and to ultimately promote their adoption by payers and access for patients, Beckley Psytech is investigating tryptamines with rapid onsets in order to reduce treatment duration. PSYCH asked Conley about the expected treatment time for intravenous psilocin.

‘We are looking at a total treatment time of around two hours, with the actual drug infusion lasting around 10 to 20 minutest,’ explained the new CSO. ‘We are going to be looking at a few things: does the drug work? Does it work as quickly as other preparations? And is it safe and well tolerated? Importantly, we want to know if they are coming out of the psychedelic experience and safe to leave the clinic within a few hours.

‘The other critical questions are how long does the acute therapeutic effect last for? Is it going to last a week, two weeks or a month? That is where both dose and length of psychedelic trip might matter. If we can get away with a 10-minute infusion that provides a good effect, we will probably stick with it. 

‘We would like time in the clinic to be as short as possible, and I think realistically we are looking at a treatment time of two or three hours. That will include the time from the person walking into the clinic, sitting down and being prepared, having an IV started and undergoing a psychedelic experience that lasts less than an hour, and then being observed to make sure they are truly down and well-orientated. They wouldn’t be able to drive home, but they would be able to return home safely within that two to three hour window.That is what we would like and that is what we will be studying in Phase II trials. 

‘We’re looking at a very standardised experience and that’s why the clinician will be trained as well. They will also gain more and more experience over time and quickly become versed on what will happen. They will administer the IV, and within a few minutes the patient will start to feel the psychedelic experience. The patient may be naive to this, but the administrator will not and will be able to prepare the patient properly. They will know they can stop the IV if the patient is having problems and stop the psychedelic experience. The treatment will be predictable and quick, and I think that will be the difference when compared to administering oral psilocybin.’

Concerns have been raised over the administration of psychedelic medicines intravenously, with critics suggesting that the drug delivery technology is fundamentally at odds with a pleasant patient experience. There are worries that this could lead to adverse incidents that detract from the treatment’s therapeutic benefits. PSYCH put these concerns to the CSO.

‘It is an obvious and very important question. For the psilocin experience, the IV is a critical part, and we’re using a fairly small IV needle for a short amount of time so it is not a long or painful infusion. More importantly, the question is whether you would like to have an experience where you sit down and the experience starts within minutes and is over in half an hour? Or, would you like to take a pill and then wait for something to happen for hours? That is the actual difference patients will be dealing with. 

‘ In our 5-MeO-DMT programme, we have a nasally inhaled product, and that seems to provide a short experience too, so we are exploring multiple methods of administering these rapid-onset compounds.. However, with psilocin we think the IV administration is the best way to deliver a short and reliable experience.

‘We also know from real world clinics in the United States that IV administration is well tolerated. There are literally hundreds of ketamine clinics across the US, and IV is the preferred method of administration. People aren’t resisting IV and, in fact, people are willing to do it again.’ 

Eleusis was acquired on the pre-clinical potential of the company’s intravenous psilocin formulation and the expertise of its research and development team. PSYCH was interested to know if Eleusis needed a buyout to be able to progress ELE-101 through clinical trials and whether Beckley Psytech had the capital to do so.

‘This remains a very tough time for biotechs, and capital, as you know, is very precious,’ recognised Conley. ‘A fortunate thing with Beckley Psytech is that we have a runway that takes us through 2025. With our plans right now, we would certainly like to grow, and we could do more things with more capitalisation. We have a core strategy that gets us to the end of Phase II studies with ELE-101 and into the clinic with 5-MeO-DMT. 

‘That is a pretty good place to be, and I’m happy about that. Although I must say in my many years of experience in neuroscience and as CSO of Neuroscience at Lilly, you can never have enough money regardless of company size. 

‘Future funding is  something we are definitely thinking about. But again, we are hoping we can go quite a way down the road as we are right now.’ 

The capital needed to conduct clinical trials beyond Phase II is significantly larger due to the regulatory requirement to conduct extensive studies in patients. PSYCH asked Conley if this posed a challenge and about the proposed time to market for ELE-101.

‘What is interesting in psychedelic therapy is that this is an intermittent therapy, rather than daily use, so, although the safety data still needs to be comprehensive, it does not need to be as large, because body exposure is much lower.

‘The studies can be relatively short, although it’s important that regulators – whether in North America, Europe or Japan – have the required maintenance of effect  data. It is relatively clear we have compounds that clear the body quickly, so we don’t need Phase II and Phase III trials as big as typical SSRI programmes.

‘We have timelines that are three or four years to market, but I’m probably one of the most shy to commit to that. At Lilly, we had a five-year development plan that we cut down to two and a half years, and that was the last major programme at Lilly I helped run.

‘That was in a field that was somewhat similar to psychedelic-assisted therapy in the respect that there were other products with similar mechanisms of action, so we understood effect size. It was good in that programme to be a fast follower because we could design trials correctly to ensure that we were answering the right questions, without the need to conduct a number of other studies that just take time. 

‘There are a number of acceleration pathways we could pursue to get into the clinic quicker, and I’m hoping for speed, but clearly it is going to be a couple more years.’ 

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