Small Pharma Inc: Positive Clinical Data For Major Depressive Disorder, Upcoming Virtual Roundtable

Short-acting psychedelics biotech company Small Pharma Inc. DMTTF shared positive outcomes from its Phase 2a study of SPL026, the first placebo-controlled trial of the DMT-based short-duration psychedelic compound for the treatment of Major Depressive Disorder (MDD). 

The trial assessed both the efficacy and safety of a 21.5mg IV dose of SPL026 paired with supportive therapy in 34 patients with moderate to severe MDD. It was split into two phases, the first a two-week blinded, randomized, placebo-controlled trial followed by a 12-week open-label stage in which all participants received one dose of the psychedelic compound.

Analyses of secondary and exploratory endpoints like effects on self-reported depression, anxiety and wellbeing -areas often negatively impacted by depression- demonstrated that patients receiving at least one dose of the psychedelic experienced clinically relevant improvements in function and mood. 

Improvements in depression scores from baseline were observed across all study time points in patients receiving SPL026, including the significant improvement in depression symptoms (compared to placebo) at two weeks post-dose. 

Actually, analysis assessing the difference between one and two-dose regimens showed no significant difference across the 12 weeks period, which further supports that a single dose of the compound is enough to produce a rapid and durable antidepressant effect.

These outcomes weigh in even more on the previously announced positive topline results on depression symptom reduction as well as the rapid and sustained therapeutic profile of SPL026 for treating MDD, and the company is getting ready to submit the full trial results for publication soon.

Small Pharma’s CMO Dr. Carol Routledge drew attention to the fact that data suggests SPL026 has “the potential to offer symptom relief from elevated anxiety, providing an encouraging basis from which to further explore its potential as a treatment for anxiety-related disorders,” which the company intends to use for a future expansion of its clinical strategy for SPL026.

CEO George Tziras added: “With an estimated cost of $1 trillion in lost global economic productivity due to depression, the potential for a treatment to offer a more holistic improvement in patients’ mental health has the potential to reduce negative societal and economic impacts of MDD.”

Virtual Roundtable Event On Short-Acting Psychedelics Will Feature Psychiatry Leaders

Small Pharma will be hosting a virtual key opinion leader roundtable with Harvard’s psychiatry professor Dr. Jerry Rosenbaum and Imperial College London’s Dr. David Erritzoe on Wednesday, March 15, 2023.

The discussion, which will foresee key topics surrounding the opportunity for short-duration psychedelic treatments in treating depression will be led by Dr. Carol Routledge. Both guests will provide insights on the current treatment toolkit available to psychiatrists and what it would take to deliver new psychedelic-based treatments for these patients.

Photo: Benzinga edit with photo by Luis Quintero on Pexels and Harbin on Wikimedia Commons.