Small Pharma has reported that the Phase IIa clinical trial of intravenous (IV) N, N-Dimethyltryptamine (DMT), SPL026, in major depressive disorder (MDD) has met its primary endpoint.

The Phase IIa clinical trial was designed for evaluating the safety and efficacy of IV SPL026, along with supportive therapy, in 34 moderate/severe MDD patients.

It included a placebo-controlled, randomised, blinded phase, which was designed to assess the efficacy of a single SPL026 dose along with supportive therapy, compared to a placebo with therapy, at two weeks after-dose.

In the open-label phase, all study participants received a single dose along with supportive therapy, and they were followed-up for an additional 12 weeks in study.

Two weeks post-dose, participants showed a -7.4 change in their Montgomery-Asberg Depression Rating scale (MADRS) scores, compared to those who have received a placebo.

The patient group treated with SPL026 had statistically significant and clinically relevant reductions in depressive symptoms.

Patients who received at least one SPL026 dose with supportive therapy showed durable improvement in depression symptoms across 12 weeks following their dose.

Small Pharma chief medical and scientific officer Dr Carol Routledge said: “SPL026 with supportive therapy was shown to have a significant antidepressant effect that was rapid and durable, with a remission rate of 57% at three months following a single dose of SPL026.

“It was encouraging to see that SPL026 demonstrated a favourable safety and tolerability profile in MDD patients in this study, consistent with our Phase I study.

“The results are clinically meaningful and enable us to progress into an international multi-site Phase IIb study, where we seek to further explore the efficacy and safety profile of SPL026 in a larger MDD patient population.”