Small Pharma has reported positive results from its study investigating the interaction of SSRIs and SPL026 – the company’s native DMT – in patients with Major Depressive Disorder (MDD).
The study investigated the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of a single 27.5 mg intravenous infusion of SPL026, alone or in combination with SSRIs, together with support therapy.
The company has confirmed that a total of 171 patients took part in the study, with the test cohort (the SSRI Cohort) consisting of patients currently on a stable treatment course of SSRIs, which have been ineffective in fully relieving their depression symptoms.
The control cohort (the Non-SSRI Cohort) consisted of patients not currently using any pharmacological treatment to treat their depression symptoms.
Study results
According to Small Pharma, the results showed that SPL026 was well-tolerated by all patients in both cohorts, with no apparent differences between cohorts, and no drug-related serious adverse events reported.
However, a small number of drug-related adverse events (AEs) were reported but were resolved during the dosing visit and were all deemed to be mild or moderate in severity.
Small Pharma has stated that in the previous, Phase I/IIa SPL026 study, patients were required to be withdrawn from SSRIs and that this latest, SPL026-SSRI drug interaction study, aimed to address this requirement to potentially enable broader patient recruitment on future large-scale studies and potentially accelerate the clinical development pathway.
The Phase 1/2a study results suggested that the antidepressant effect of SPL026 in combination with supportive therapy showed a rapid onset at one-week post-dose and had an antidepressant effect with a 57% remission rate at 12 weeks.
The latest study results reaffirmed the Phase IIa SPL026 study, says Small Pharma.
However, the company highlights that a marked improvement was observed between the antidepressant effect of SPL026 treatment in the SSRI Cohort compared to the Non-SSRI Cohort – suggesting a potentially enhanced efficacy effect when SPL026 is administered in combination with SSRIs.
Dr Carol Routledge, Chief Medical and Scientific Officer of Small Pharma, stated: “Our primary goal in conducting this Phase 2b 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understand if SPL026 could be safely administered in conjunction with SSRIs to assess whether patients would need to be withdrawn from their SSRI medication in future trials.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.
“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.
“This was a small study, but the findings are both interesting and encouraging and warrant further exploration.”
George Tziras, CEO of Small Pharma, said: “These positive safety and tolerability results further support the patient access strategy for our DMT programmes.
“There may be potential in the future to safely deliver a DMT-based treatment to patients on SSRIs that do not adequately relieve their depression symptoms. Moreover, the marked antidepressant effect seen in the SSRI patient cohort indicates the potential for a combination treatment.
“We look forward to exploring these findings further as part of the integrated DMT programme with Cybin, subject to completion of the proposed arrangement transaction.”
