Small Pharma Announces Positive 6-month Data from Phase 2a DMT Trial

The article Small Pharma Announces Positive 6-month Data from Phase 2a DMT Trial was originally published on Microdose.

Small Pharma releases additional data from its Phase 2 trial — nearly 2/3 of patients remained in remission after 6 months.

Over the last half-decade, while rates of depression have been skyrocketing, scientists in labs across the Western world have been publishing papers showing that illegal psychedelics such as psilocybin, LSD, DMT and MDMA can effectively treat many patients.

During this period, however, an essential question has emerged: which psychedelic, when compared against each other, will be the most effective and practical when used as a medicine?

Rather than just an academic question, the answer will have many real-world consequences for depression patients, their wallets (or the wallets of governments and insurance companies), and investors in the psychedelic space.

It is in this context that on April 4th, the biomedical company Small Pharma (TSXV: DMT, OTCQB: DMTTF) published further data from their Phase 2a clinical trial, which may support their thesis that DMT is the best psychedelic drug candidate.

Small Pharma’s Phase 2a trial using DMT

This trial attempted to treat Major Depressive Disorder, using an intravenous formulation of DMT —which Small Pharma calls SPL026.

The original part of the trial, which had 34 patients — half of whom were in a placebo group — had amazing results. Small Pharma reported in January that of those who received the 21.5mg dose of IV DMT — combined with therapy — 57% of patients improved so much that they entered remission. Importantly, these results lasted for three months.

Now, after dosing some additional patients in an open-label portion of its study, Small Pharma has delivered a 6-month update. 

The headline number is that of those who reached remission after 3 months — 64% of patients were still in remission after a half year. Or, in other words, a full 40% of patients entered and stayed in remission from their Major Depressive Disorder, for a minimum of 6 months.

Looking at the graph showing remission rates over time, we can see that they fluctuate between 40%-50%, showing that the results are stable.

If these results can be reliably replicated, this DMT study should provide hope to many people suffering from depression — and perhaps Small Pharma investors.

Additional evidence that DMT may be a winner

While other psychedelics, such as LSD, psilocybin and MDMA have shown similarly great results in some studies attempting to treat mental health ailments such as depression, DMT has a huge cost advantage over other psychedelics.

This cost advantage comes in the form of the duration of psychedelic effects a person experiences on DMT as compared to other psychedelics. For example, the effects of psilocybin, LSD and MDMA can all last between 6-10 hours.

As during this time the patient needs to be under the supervision of a highly trained — and therefore highly paid — therapist and their support staff, the bill for one such treatment can rise into the high hundreds of dollars, if not thousands of dollars.

By contrast, patients in Small Pharma’s DMT trial only experienced a “20 to 30-minute psychedelic experience.” This means that the therapy and supervision portion of a DMT experience may cost less than 10% of a psilocybin or MDMA therapy session.

If studies continue to show that DMT can effectively treat between 40-50% of depression patients — and other psychedelics are not greatly more effective — then DMT will be by far more cost-effective.

Given these results, one can easily imagine a twice-a-year treatment where a patient undergoes a two-hour DMT therapy session — with preparation time before and integration time after the psychedelic portion of the session, as well as dedicated therapy sessions for integration. 

If DMT does become the psychedelic medicine of choice in treating depression, then Small Pharma is likely to be the greatest beneficiary — other than the patients of course. It has progressed DMT research the farthest, and would likely have a several year period where they would be the sole provider of DMT. 

Of course, as DMT is in the public domain and not patentable, eventually other companies would catch up. By that time, however, Small Pharma hopes to have their improved (and patentable) version of DMT, which they call SPL028. Small Pharma hopes that this longer-lasting version of DMT will be an even more effective medicine than the original, though we the public won’t be able to make any judgment on that until we see compelling data.

In publishing this data, Small Pharma has excited at least some institutional investors. The investment bank EF Hutton, for example, published a note after the data release, reiterating their Buy rating, giving the company a 12-month C$5 price target (extremely bullish considering the current stock price of under 10 cents).

All of that being said, I will end with a note of caution. This is one small clinical study. In total, only 25 patients both received the DMT treatment, and participated in the 6 month follow-up. Plus, the fact that the second part of the study was open-label (meaning no placebo group), further reduces the confidence with which we can predict that these results will be repeated. 

To be clear, I am not saying I have any reason to believe that this study will not be replicable, just that we need to wait to see it repeated multiple times in larger groups of more than a hundred people before we can come to any solid conclusions.

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