Small Pharma reports positive top-line results from phase IIa trial of SPL026 in major depressive disorder

An interesting January 25th press release stated: "Small Pharma Inc. a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, today announces that SPL026, intravenous N,N-Dimethyltryptamine (“DMT”), with supportive therapy for the treatment of Major Depressive Disorder (“MDD”) met the primary endpoint in its Phase IIa clinical trial, demonstrating a statistically significant and clinically relevant reduction in depressive symptoms at two-weeks post-dose, as compared to placebo. Further analysis of key secondary endpoints demonstrated a rapid and durable antidepressant effect to 12-weeks.  The trial investigated the efficacy and safety of intravenous (“IV”) SPL026, with supportive therapy, in 34 patients with moderate/severe MDD. Participants who entered the trial on pharmacological antidepressant medication were withdrawn from their treatment prior to dosing. Patients were dosed with a short IV infusion of 21.5mg of SPL026, resulting in a 20 to 30-minute psychedelic experience. The dose was selected as a result of data analysis from the Company’s Phase I study confirming that it was well tolerated and delivered a consistent psychedelic experience in healthy volunteers.  The two-staged Phase IIa study included a blinded, randomized, placebo-controlled phase, where the primary endpoint was to assess the efficacy of a single dose of SPL026 with supportive therapy (N=17) versus placebo with therapy (N=17) at two-weeks post-dose. All study participants were subsequently enrolled into an open-label phase of the study where they received a single dose of SPL026 with supportive therapy, and were followed-up for a further 12-weeks in study**. This open-label trial design enabled the assessment of durability of antidepressant effect, as well as the comparative efficacy and safety of a one versus two dose regimen of SPL026.  Efficacy was assessed using the Montgomery-Asberg Depression Rating scale (“MADRS”) to measure any potential change in patients’ depression from baseline. MADRS was assessed by independent raters who were not present at dosing and were blinded to the overall treatment.  The Phase IIa study met the primary endpoint demonstrating a statistically significant and clinically relevant reduction in depressive symptoms two-weeks following a dose of SPL026 with supportive therapy, compared to placebo, demonstrating a -7.4 point difference in MADRS (p=0.02). Analysis of key secondary endpoints demonstrated a rapid onset of antidepressant effect one-week post-dose, with a statistically significant difference in MADRS score between the active and placebo groups of -10.8 (p=0.002).  Across the 12-week open-label phase, patients who received at least one active dose of SPL026 with supportive therapy reported a durable improvement in depression symptoms. No apparent difference in antidepressant effect was observed between a one and two dose regimen of SPL026. The total mean reduction in MADRS from baseline after a single dose of SPL026 was –15.4 at 12-weeks."

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