In June, Cybin (NEO: CYBN, NYSE: CYBN) announced that they were purchasing a Phase 1 DMT clinical trial from Entheon Biomedical (CSE: ENBI, OTCQB: ENTBF). With 50 healthy volunteers who smoke tobacco, this is the largest DMT Phase 1 trial to date.
Recently, I had the opportunity to ask Cybin’s CEO Doug Drysdale about the purchase in an AMA —Ask Me Anything— hosted by Psychedelic Spotlight. While the full AMA video is coming soon, in this article I will cover our conversation on the rationale behind the transaction.
But first, a little background information.
When the purchase was made public, Cybin said they bought the trial to accelerate the development timeline for their next-generation DMT, CYB004. According to Cybin, in preclinical trials CYB004 has been shown to last longer than traditional DMT and it may be safer as well —though I will wait to see in-human clinical data before making any definitive statements.
Cybin said that this trial would “yield essential safety and dosing optimization data,” allowing the company to “replace Cybin’s planned pilot study for CYB004.” Specifically, Cybin estimates that by purchasing this trial, they will accelerate the development of CYB004 by approximately 9 months.
Despite this explanation, at the time I was left confused as to how purchasing a Phase 1 trial on classical DMT would accelerate their progress on CYB004 by nine months. After all, as CYB004 is a new medicine, it would still have to go through the Phase 1 safety process itself, regardless of whether Cybin had a Phase 1 classical DMT study.
Luckily, I was not alone in my query. To source the questions for the AMA, I sought the aid of retail investors in the Reddit group r/CybinInvestorsClub, and one user asked essentially the same question.
Responding to the question, Doug Drysdale explained that purchasing the Phase 1 DMT clinical trial would be beneficial to their CYB004 program in two ways: by accelerating the timetable and by providing dosing data.
To start with the acceleration, the reason it will speed up the development process of CYB004 is quite simple; Cybin was going to have to do a Phase 1 classical DMT study anyhow. In order to confidently say that CYB004 is more effective and safer than traditional DMT, Cybin needs to compare CYB004 data with quality data from the original, something that is not readily available.
According to Drysdale, “We are fortunate to be able to have access to generic DMT, which we can test in humans. And we were planning to do this, in any case, ourselves. But as an alternative, we decided to acquire the ongoing study from Entheon. Our own study would have started around September or October; Entheon’s study started at the beginning of the year. So that’s a clear nine months or so of a head start.”
In short, Entheon’s DMT study won’t speed up CYB004’s progress by shortening the amount of time spent studying CYB004. It will speed up the process by removing the need to study classical DMT.
The second reason for purchasing the trial is perhaps more significant. According to Drysdale,
“The real advantage for us is that there is not a lot of public, detailed information on dosing DMT… What we don’t have details on before this study is exactly how much the [initial dose] should be… and how much to infuse, over what time frame to keep a patient in that DMT space. So this study is quite a large study, it’s got 50 healthy volunteers…with escalating doses, and through that we will learn a lot about the dosing dynamics and dose optimization of DMT. So then we will have human data, using DMT, and we’ll have preclinical animal models comparing DMT with CYB004. So when we come to the first in-human study with CYB004, instead of having to do those explorations with CYB004, it will be more of a confirmatory study comparing CYB004 to DMT, because we will have a lot of human data already, rather than having to start from scratch with CYB004. So that is going to save us an awful amount of time.”
In other words, since there is relatively little clinical research into DMT, we don’t have a firm understanding of what an appropriate dose level is. Cybin’s new Phase 1 DMT clinical trial, which tests different dose levels, will help give the company a better picture. Cybin can then use that information when it comes to their Phase 1 CYB004 study, as they will not have to guess widely at an appropriate dose. This should likewise further speed up the development process.
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If you have any tips in the psychedelics space, reach out to James Hallifax by email, at james@psychedelicspotlight.com
You can also reach him on Twitter, @Psy_Invest
