Today, psychedelic medicine company Small Pharma (TSXV: DMT, OTCQB: DMTTF) announced the results of its Phase 2a clinical trial, treating moderate to severe Major Depressive Disorder (MDD) with DMT-assisted therapy.
This trial carries immense significance, as it is the first-ever clinical trial attempting to treat a mental health disorder with DMT, the more hallucinogenic — but shorter-acting — chemical cousin to psilocybin.
The study, which had 34 patients, delivered stunning results. Before diving into the details, I’ll give you the most impressive statistic:
3 months after a single dose of DMT — paired with preparation and integration therapy — 57% of depression patients were in remission.
As I said, stunning.
Now, for the details.
Deeper Look at Small Pharma Phase 2a trial results
Small Pharma’s Phase 2a trial was actually divided into two parts. First, the patients were split into two groups: those who received the intravenous DMT and those who received the placebo. Both groups received preparatory therapy before the administration of either the DMT or the placebo, and integration therapy after the experience had ended. There was no therapy during the psychedelic session. The entire process took between one hour and 45 minutes, to two and a half hours.
Two weeks after the initial dose, depression scores were measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). The psychedelic researchers found that those who had received DMT saw their MADRS depression score drop by 11 points, which was 7.4 points more than the placebo.
This meant that two weeks after treatments, 35% of those who received the DMT saw their depression symptoms drop by at least 50% (remitters). Furthermore, 29% of people improved so much that they were considered to be in remission.
Next, after this data was compiled, all trial participants received another dose of DMT (or their first one if they were in the placebo group originally), effectively adding an open-label trial to their data.
This is interesting, because we also get comparative data on the effectiveness of one DMT dose, as compared to two doses.
In the open-label part of Small Pharma’s Phase 2a trial, the results showed that 3 months post-treatment, those who received a single dose of DMT had a MADRS depression score 15.4 points lower than when they started treatment. This corresponds to the 57% remission rate mentioned above.
This is, quite simply, paradigm-shifting (if the results can be repeated).
Other recent antidepressant clinical trials have seen much lower reductions in depression levels than the 15.4 points reported by Small Pharma using DMT. For example, at one month after treatment, the drug AUVELITY caused a reduction of 5.5 points, REXULTI caused a reduction of 3.2 points, and VRAYLAR caused a reduction of 2.6 points.
Interestingly, those who received two doses of DMT had less impressive scores, with only 33% entering remission. But given the small sample size, this difference was not found to be statistically significant. We will need to see more data on the effectiveness of one versus two doses before we know whether one dose is superior. For now, what is important is that both one and two doses showed sustained effectiveness in treating depression up to 3 months after dosing.
One last important note is that there were no serious adverse events reported. In other words, DMT was found to be safe. There were 24 minor to moderate adverse events, such as nausea and anxiety, but all of these issues resolved themselves on the day of administration.
These results are important. If DMT is found to be at least equally as effective in treating mental health disorders such as Major Depressive Disorder as its chemical cousin psilocybin, then in all likelihood it would be the more practical, scalable and affordable psychedelic medicine.
This is since, despite a very similar chemical structure, the psychedelic experience of DMT only lasts between 15-30 minutes, as compared to 6-10 hours for psilocybin. This means that for a person to receive psilocybin therapy, a highly paid therapist and their support staff must be paid for almost a full day’s work — not to mention the added preparation and integration therapy. This means that the cost can raise above a thousand dollars, pricing out many people.
If the DMT-assisted therapy, combined with the preparation and integration sessions, lasts less than three hours, the cost would be much lower. And if the two medicines are equally effective, then it is a no-brainer which one is the most scalable and affordable medicine.
Positive Trial News, But More Studies to Follow
Despite this very positive news, we must take a breath and allow for a reality check. This is only the very first clinical trial attempting to treat ANY mental health condition with DMT, and there was a relatively small sample size of 34 patients.
Before we can make ANY definitive statements on the effectiveness of DMT-assisted therapy, either in absolute terms or in relation to other psychedelics such as psilocybin, we are going to need to see much more data.
Luckily, over the coming year we should see more DMT clinical trials start, and we will get a six-month follow-up on the current trial. In fact, in the first half of 2023, Small Pharma intends to start three different DMT clinical trials.
First, is a follow-up Phase 2b study, which will attempt to replicate the findings of this study, with a larger population. But the company also plans on launching a Phase 1b trial studying the interaction between DMT and SSRIs, the most common antidepressant.
This is important, as people who have been on SSRIs for years may have negative side effects when going off them, which could diminish the effectiveness of DMT therapy. If they could remain on their current medication, and it was safe to do so while taking DMT, then it is possible the treatment could be more effective. That, however, is just speculation until we see some trial results.
Finally, Small Pharma will also begin a Phase 1 safety trial on a next-generation DMT. In the current trial, Small Pharma used its own DMT formula, called SPL026. However, Small Pharma wants to test a longer-acting DMT, which they created and named SPL028. It is possible that a longer-acting DMT — while still being shorter-acting than psilocybin — could be more effective.
Despite this only being a preliminary study, many investors are excited by the positive results. For example, investment bank EF Hutton Group drastically raised their 12-month price target for Small Pharma. Before the results, their price target sat at C$2.50. Post results, they doubled it to C$5.00.
