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DMT: A Trip To Get Away From Depression?

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With the revival of psychedelic medicine well underway, different academic groups and clinical research companies are investigating the features and effects of psychedelic experiences on mental health. One such company is London-based Small Pharma. Founded in 2015 by CEO Peter Rands, Small Pharma is undertaking groundbreaking clinical research into the efficacy of the psychedelic N,N-Dimethyltryptamine (DMT) against Major Depressive Disorder (MDD). We caught up with Rands to discuss the unique features of DMT and updates from the company’s latest trials.

Ruairi Mackenzie (RM): DMT’s main utility versus other psychedelics is a shorter “trip” – how significant is the difference in trip length and experience versus, for example, psilocybin?

Peter Rands (PR):
Psychedelic medicine is an emerging field. Small Pharma’s current Phase I/Phase IIa trial is the first regulated clinical trial into the effects of DMT-assisted therapy in psychedelic-naive healthy subjects and in patients with MDD. But we are still some way off studies that compare different types of psychedelic-assisted therapies.

DMT is thought to offer a more immersive experience than LSD or psilocybin – though over a much shorter period of time. A typical DMT experience lasts less than 30 minutes, while a psilocybin experience can extend over five or six hours.

We see the seemingly shorter acting experience as highly relevant to the real-world implementation of these therapies if they reach market approval. We anticipate that a DMT assisted therapy session could last under 2 hours, comparative to an 8-hour session with psilocybin-assisted therapy. This, we believe, could provide greater convenience for both the treating health professional and patient.

In terms of the experience, treatment with DMT, whilst objectively short lasting, can be described as more intense than, say, psilocybin. We are very focused on the patient experience and so truly believe that adjunct wraparound support from a trained therapist is critical for both improving clinical outcomes but also ensuring the patient feels safe and comfortable throughout the treatment. We have established a proprietary DMT-focused therapy protocol and are training therapists to be well prepared to deliver this novel treatment, including supporting patients with challenging experiences.  All psychedelic experiences have the potential to be challenging – indeed, this may not be a negative outcome as it may well be the case that more challenging experiences lead to more therapeutic benefits in the long term.

What were the headlines from your Phase I trial?

In September of this year, we announced the successful completion of our Phase I UK regulated clinical trial of SPL026 (DMT) in combination with psychotherapy.

Our proprietary intravenous DMT formulation, SPL026, was given to 32 healthy volunteers with no prior experience of psychedelics in a dose-escalating, placebo-controlled Phase I study.

All of the volunteers were happy to take the drug beforehand, none said they regretted the experience afterwards and none reported any serious after-effects. The drug provides preliminary evidence that our DMT formulation appears to have a remarkably good safety and tolerability profile compared with many other medicines. In addition, we were able to select a dose that elicited a psychedelic experience in all subjects whilst remaining well tolerated and causing no serious side effects, to administer in our subsequent Phase IIa study investigating its effects in a patient population.

RM: What are the key details of your upcoming Phase IIa clinical trial?

We initiated dosing of our Phase IIa in October. The Phase IIa is a blinded, randomized, placebo-controlled proof of concept study of SPL026 in combination with psychotherapy in 42 patients with MDD.

The study aims to assess the efficacy of one versus two doses of SPL026 versus placebo in combination with psychotherapy, while furthering the Company’s safety and tolerability dataset. Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure any potential reduction in the patients’ depression. Topline results are anticipated in the first half of 2022.

RM: The trial is to be placebo-controlled. What placebo will be used? How can trials involving psychedelics effectively blind patients when a trip is part of the experience?

We have selected a standard placebo that does not contain any psychoactive substance for this trial. Other studies have considered very low doses of the selected psychedelic in attempts to maintain the study blind. However, we believe that very low doses of psychedelics show no real clinical differences to a standard placebo, given such a dose is not believed to have any clinical effects.

We acknowledge that blinding in psychedelic trials is a challenge, however, it is not unique to psychedelic clinical studies as many other treatments in development with obvious clinical effects (either efficacy and pharmacodynamic effects or side-effects) have been challenging to blind. However, to try and optimize blinding in our trial, we have chosen to use independent clinical assessors, who have no direct observation of the patient during the treatment and so are blind to treatment, to rate patients using the selected clinical efficacy scales.

RM: What is next for Small Pharma beyond the targeting of major depressive disorder?

We believe that MDD has a significant unmet need that has been negatively impacted by the COVID-19 pandemic. As such, our primary current attention is to ensure we place significant focus on optimizing the treatment protocol for MDD in order to maximize the potential clinical benefits we could deliver to millions of individuals around the world.

However, we do recognize that, both from other commercial companies and in academic research, there is a growing body of evidence for the application of psychedelics in other mental health and neurological conditions. We are excited by this promising potential and of course we are always exploring the latest research to provide the basis of future clinical programs. We intend to regularly update with developments of other clinical programs and so follow us to stay tuned with our latest updates!

Peter Rands was speaking with Ruairi J Mackenzie, Senior Science Writer for Technology Networks