Small Pharma has reported positive top-line results from its Phase 2a Trial of SPL026 in Major Depressive Disorder (MDD).
Small Pharma’s SPL026 – an intravenous DMT formulation – with supportive therapy for the treatment of MDD has met the primary endpoint in its Phase IIa clinical trial.
Results have demonstrated a statistically significant and clinically relevant reduction in depressive symptoms at two-weeks post-dose compared to a placebo and further analysis of key secondary endpoints demonstrated a rapid and durable antidepressant effect up to 12 weeks.
Chief Medical and Scientific Officer Dr Carol Routledge said: “We are pleased that a significant number of patients benefited from the treatment in our trial.
“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 1 study. The results are clinically meaningful and enable us to progress into an international multi-site Phase 2b study where we seek to further explore the efficacy and safety profile of SPL026 in a larger MDD patient population.”
For the trial, participants who entered on pharmacological antidepressant medication were withdrawn from their treatment prior to dosing.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 1 study confirming that it was well tolerated and delivered a consistent psychedelic experience in healthy volunteers.
Small Pharma has stated key findings include:
- Primary endpoint met with a statistically significant -7.4 point difference between SPL026 (21.5mg) and placebo at two-weeks post-dose as measured by MADRS change from baseline.
- Antidepressant effect of SPL026, with supportive therapy, demonstrated a rapid onset at one-week post-dose with a statistically significant difference in MADRS of -10.8 versus placebo.
- Durable antidepressant effect with a 57% remission* rate at 12-weeks following a single SPL026 dose with supportive therapy.
- No apparent differences identified in antidepressant effect between a one and two dose regimen of SPL026.
- Favourable safety and tolerability profile demonstrated with no drug-related serious adverse events reported. All adverse events related to treatment were considered mild or moderate.
Small Pharma CEO, George Tziras, commented: “MDD affects the lives of hundreds of millions of people worldwide. The scale of the unmet need indicates the importance of investigating alternative new treatments.
“Our goal is to develop proprietary, scalable and reimbursable short-duration psychedelics with supportive therapy to address this need.
“I am delighted with our top-line results, which demonstrate proof-of-concept for SPL026 and provide encouraging support for our broader portfolio.
“I want to thank each patient who took part in this trial, as well as their families, the trial investigators, the employees of the trial sites and everyone who has supported the successful completion of this study.”
Clinical Psychiatrist at Imperial College London and Chief Investigator of the Phase 1/2a study, Dr David Erritzoe, added: “The results are exciting for the field of psychiatry. We now have the first evidence that SPL026 DMT, combined with supportive therapy, may be effective for people suffering from MDD.
“For patients who are unfortunate to experience little benefit from existing antidepressants, the potential for rapid and durable relief from a single treatment, as shown in this trial, is very promising.”
The detailed results of the Phase 2a trial are expected to be presented at upcoming scientific meetings and published in a peer-reviewed journal.
