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  • World’s first clinical trial for DMT-assisted therapy for Major Depressive Disorder shows consistent quality of psychedelic response in Phase I
  • Analysis provides additional insight into dose-related effects on the primary outcomes of safety and tolerability as well as on pharmacodynamic measures
  • Key results from the study indicated that no serious adverse events were reported
  • Of 20 drug-related adverse events, all were mild (85 per cent) or moderate (15 per cent) and resolved rapidly and independently
  • The full dataset is anticipated to be published in a peer reviewed journal
  • Small Pharma Inc. (DMT) is down 1.69 per cent, trading at C$1.29 at 10:18 am EST

Small Pharma (DMT) has shared analysis of Phase I data from the clinical trial of SPL026 for the treatment of Major Depressive Disorder.

In the dose-escalating, placebo-controlled Phase I study, 32 healthy psychedelic naïve volunteers across four dose cohorts received either SPL026 in combination with psychotherapy (n=24) or placebo (n=8).

This analysis provides additional insight into dose-related effects on the primary outcomes of safety and tolerability as well as on pharmacodynamic measures, including the treatment experience and subject well-being.

Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma said: “The analysis of the unblinded data set supports our choice to explore the antidepressant potential of our selected dose of SPL026 in the Phase IIa trial.”

“As for the subjects’ experience, most reported that it was pleasurable, not too challenging, and most importantly, nobody expressed any regrets. Additionally, the strong safety profile and rapid clearance of SPL026 from the body provides the potential for a scalable treatment with limited monitoring needs post-dosing,” added Routledge.

Key results from the study indicated that no drug-related serious adverse events and minimal short-lived adverse events were reported on the dosing day.

Of 20 drug-related adverse events, all were mild (85 per cent) or moderate (15 per cent) and resolved rapidly and independently.

The data confirms the selected dose of SPL026 taken forward into Phase IIa most consistently delivers the target treatment profile across subjects through a multi-dimensional assessment including safety, tolerability, pharmacokinetic and pharmacodynamic parameters.

The full dataset is anticipated to be published in a peer-reviewed journal.

David Erritzoe of Imperial College London, Chief Investigator of the Phase I/IIa study said: “Psychedelic-assisted therapies have the potential to completely change the treatment paradigm of mental health conditions. The additional insights from Small Pharma’s Phase I study show promising results at this stage of the development.”

“The dosing time of 30 minutes, in comparison with up to six hours seen with alternative approaches, has the potential to offer a real benefit in terms of the treatment regimen for both patients and providers,” added Erritzoe.

The blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study of SPL026 in combination with psychotherapy in 42 patients with MDD remains on track to deliver topline results in the first half of 2022.

This study will assess the efficacy of one dose of SPL026 versus a placebo, and one versus two doses of SPL026 in combination with psychotherapy in patients with MDD while bolstering existing safety and tolerability data.

Small Pharma is a neuroscience company specialized in discovering and developing novel treatments for mental health conditions, with a focus on depression. 

While DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects.

Small Pharma Inc. (DMT) is down 1.69 per cent, trading at C$1.29 at 10:18 am EST.

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