DMT-SSRI combination shows potential for depression

Results from Small Pharma’s Phase Ib study in selective serotonin reuptake inhibitor (SSRIs) interaction with SPL026, native N, N-dimethyltryptamine (DMT) has revealed that 92 percent of patients gained remission from major depressive disorder (MDD).

At Week 4, 100 percent of patients in the SSRI cohort responded to SPL026 (DMT), according to the firm.

Currently, SSRIs are the standard of care for MDD. The study was done to assess whether SPL026 (DMT) could be safely administered with or without SSRIs.

Study findings – major depressive disorder

In the present study, a single 27.5 mg intravenous infusion of SPL026 was administered alone or in alongside SSRIs, together with support therapy, in the 17 (out of 18) evaluable patients.

A marked improvement was observed between the antidepressant effect of SPL026 treatment in the SSRI cohort compared to the non-SSRI cohort. While the efficacy observed in the non-SSRI cohort was comparable to the efficacy data previously observed in Small Pharma’s SPL026 Phase IIa clinical trial.

However, the antidepressant effects observed in patients given an SSRI were of a greater magnitude. This therefore indicates there is a potentially enhanced efficacy effect when SPL026 is given in combination with SSRIs, according to the company.

“Our primary goal in conducting this Phase Ib study was to understand if SPL026 could be safely administered in conjunction with SSRIs to assess whether patients would need to be withdrawn from their SSRI medication in future trials. While we were very pleased that the study demonstrated that patients may not need to be withdrawn, we were not expecting to see such a marked difference in efficacy when administering SPL026 in combination with SSRIs compared to SPL026 alone,” Dr Carol Routledge, Chief Medical and Scientific Officer of Small Pharma commented.

“The potentially enhanced efficacy effect of a DMT-based treatment when administered with SSRIs could lead to greater therapeutic benefit for patients, and a compelling argument for positioning it earlier in the treatment pathway,” Dr Routledge added.

“The marked antidepressant effect seen in the SSRI patient cohort indicates the potential for a combination treatment,” George Tziras, Chief Executive Officer of Small Pharma acknowledged.

Future DMT clinical studies

Tziras also stated that the data from the study are planned to be investigated further as part of an integrated DMT programme with Cybin, a biopharma company focusing on psychedelic therapeutics.

As part of a prior agreement, Cybin is set to acquire Small Pharma Inc. The deal is anticipated to be completed in Q4 2023.