While atai Life Sciences (Nasdaq: ATAI) may be cutting parts of its pipeline, this apparently has not stopped the company from launching a new DMT clinical trial.
On Wednesday, atai published a press release celebrating the first patient being dosed in their Phase 1 DMT safety trial. The study, which of course is randomized, double-blinded and placebo-controlled, will compare two different versions of VLS-001, atai’s synthetic version of DMT.
The first version will deliver atai’s DMT using a “buccal” formulation. In short, this means that the DMT is delivered in a tablet format, which dissolves in the patient’s mouth while they hold it between their gums and their cheek. Using this method, the DMT diffuses through tissues that line the mouth, to enter directly into the bloodstream of the trial participants.
The second method is using an intravenous formulation, where the DMT will be constantly administered through a needle.
The main purpose of this clinical trial is to compare and contrast the safety, tolerability and bioavailability of the two delivery methods, with the goal of determining which method will be best for their upcoming Phase 2 trial, attempting to treat Treatment-Resistant Depression with the potent psychedelic.
This is important, as Treatment-Resistant Depression (TRD) affects up to 100 million people worldwide, who currently struggle to find effective treatments.
The trial participants will also use atai’s “IDEA-1 digital therapeutic app to provide contextual ‘(mind)set-and-setting’ prior to dosing, as well as behavioral activation therapy, group therapy, and patient monitoring post-dosing.” The data collected from this app will also be used to help structure the procedures for their Phase 2 trial.
We should expect the initial Phase 1 data readout comparing the two administrative routes sometime before the end of the first half of next year.
Thoughts and Analysis
Personally, I am very excited to see another DMT clinical trial beginning. DMT, while having similar if much more potent effects as psilocybin, LSD and other classical tryptamine psychedelics, has not been studied in a clinical setting nearly as much as its chemical cousins.
And while psilocybin therapy has had extremely positive results in treating a range of mental health conditions from Alcohol Use Disorder to Treatment-Resistant Depression, in a clinical setting the duration of effect — which can last 6-8 hours — makes the treatment very expensive. This is because a (highly paid) therapist will have to watch over the patient for the better part of a day, not to mention the salaries of other needed support staff. This will price out many lower-income individuals that need help, at least in locations without universal healthcare (looking at you, America).
If — and to be clear this is a big if, as DMT needs to be tested and validated in clinical trials first — DMT, being similar in effect to psilocybin, can achieve similar results in helping heal mental wounds while only having a duration of effect of around 30 minutes, then from a cost analysis perspective it would be the far superior medicine.
As I mentioned above, relatively few companies are studying DMT, with Small Pharma (TSXV: DMT, OTCQB: DMTTF), and Cybin (NEO:CYBN, NYSE AMERICAN:CYBN) being two exceptions. With atai and their deep pockets jumping into the ring, it looks like DMT research will really start to heat up.
