DMTTF - Small Pharma's psychedelic drug helps reduce depression symptoms in mid-stage study

Small Pharma's ( OTCQB:DMTTF ) psychedelic drug SPL026, with supportive therapy, met the main goal of showing reduction in depression symptoms in phase 2a trial.

The two-staged Phase 2a study included evaluated a single dose of SPL026 (intravenous N,N-Dimethyltryptamine (DMT)) with supportive therapy (N=17) versus placebo with therapy (N=17) at two-weeks post-dose to treat moderate/severe Major Depressive Disorder (MDD). All participants were then enrolled in an open-label phase in which they received a single dose of SPL026 with supportive therapy, and followed-up for another 12-weeks.

DMT is a type of hallucinogen.

The London-based company said that the study met its main goal with a statistically significant -7.4 points difference between SPL026 (21.5mg) and placebo from baseline, at two-weeks post-dose.

Efficacy was assessed using the Montgomery-Asberg Depression Rating scale (MADRS) — a questionnaire used to measure the severity of depression symptoms.

Antidepressant effect of SPL026, with supportive therapy, showed a rapid onset at one-week post-dose with a statistically significant difference of -10.8 points compared to placebo, the company added.

In addition, durable antidepressant effect with a 57% remission rate at 12-weeks was seen after a single SPL026 dose with supportive therapy.

The company, however, noted that no apparent differences were seen in antidepressant effect between a one and two dose regimen of SPL026.

"Our goal is to develop proprietary, scalable and reimbursable short-duration psychedelics with supportive therapy to address this need. I am delighted with our top-line results, which demonstrate proof-of-concept for SPL026 and provide encouraging support for our broader portfolio," said Small Pharma CEO George Tziras.

The total mean reduction in MADRS from baseline after a single dose of SPL026 was –15.4 at 12-weeks, according to the company.

Small Pharma said that there were no drug-related serious adverse events. There were 19 Adverse events (AEs) in the SPL026 group deemed possibly related to treatment in the blinded phase, while 4 were in the placebo group. All these were mild or moderate in severity.

There were 24 AEs deemed possibly related to treatment in the open-label phase, Small Pharma noted.

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