Short-acting psychedelics biotech Small Pharma Inc. (OTCQB: DMTTF)’s proprietary intravenous (IV) DMT-based drug SPL026 delivered positive topline results in a Phase 2a trial for the treatment of Major Depressive Disorder (MDD).
The trial, which was aimed to assess the efficacy and safety of IV SPL026, was paired with supportive therapy in 34 patients with moderate to severe MDD. Two-staged, the study investigated the efficacy of a single dose with supportive therapy vs. placebo with therapy at two weeks post-dose.
Prior to withdrawing antidepressants from participants, the study’s dose was a short IV infusion of 21.5mg of SPL026, translating to a 20 to 30-minute psychedelic experience.
The second, open-label phase had all participants enrolled and receive a single dose of SPL026 with supportive therapy, then followed up for a further 12 weeks. This stage allowed Small Pharma to assess the durability of the antidepressant effect as well as the comparative efficacy and safety of a one vs. two-dose regimen of its psychedelic compound.
Topline results showed SPL026 reduced depressive symptoms in the following two weeks after administration.
In the case of patients who received at least one …