Could DMT Therapy Be The Future Of Brain Injury Treatment? This Study Has Promising Results

Short-acting psychedelics company Small Pharma Inc. DMTTF has shown positive outcomes from a six-month follow-up of its Phase 2a clinical trial of proprietary DMT compound SPL026 for the treatment of Major Depressive Disorder (MDD.) 

The trial assessed the safety and efficacy of a 21.5mg intravenous (IV) dose of SPL026 paired with supportive therapy in 34 patients with moderate to severe MDD.

Conducted in two stages, the first was a blinded, randomized, placebo-controlled two-week phase with the primary endpoint of evaluating the efficacy of a single dose of the psychedelic compound with supportive therapy. 

In the second, open-label phase, all study participants received SPL026 treatment and were followed up for a further three months study. 

25 patients from both treatment arms (single and two-dose regimens) completed an out-of-study follow-up for six months after the open-label dose.

Of the total patients completing the full six-month follow-up, 14 had initially achieved remission within the three-month in-study period and, of those, 9 (or 64%) sustained remission at six months. 

While a single dose paired with therapy demonstrated “a rapid and robust antidepressant effect” after 1 week, CMO Dr. Carol Routledge says the high percentage of sustained remitters informs the company on treatment durability and approach to patient retreatment within the trial in face of upcoming Phase 2b study’s design.

"This data indicates that SPL026 can elicit a fast-acting antidepressant response that appears to be enduring in several cases”, adding that recent neuroimaging and preclinical findings hint DMT and other related serotonergic agonists produce a regenerative action," said Dr. Robin Carhart-Harris, Ph.D.

The company's CEO George Tziras concluded: “Given these clinical outcomes from one or two treatments, this could further offer potential value to healthcare systems that face challenges with patients who struggle to adhere to their daily antidepressant use.”

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