Patients with Major Depressive disorder (MDD) have been shown to achieve remission within three months following treatment with SPL026 combined with supportive therapy in Small Pharma’s Phase 2a trial.
The results showed that 64% of patients in the trial sustained remission up to six months. The trial investigated the efficacy and safety of 21.5mg intravenous (IV) SPL026 with supportive therapy in 34 patients with moderate to severe MDD.
George Tziras, Chief Executive Officer of Small Pharma, stated: “We are pleased to see that participants in our study experienced durable relief from their depression for an extended period of time.
“Given these clinical outcomes from one or two treatments, this could further offer potential value to healthcare systems that face challenges with patients who struggle to adhere to their daily antidepressant use.”
The study
The first stage of the study consisted of a blinded, randomized, placebo-controlled two-week phase where the primary endpoint was to assess the efficacy of a single dose of SPL026 with supportive therapy.
In the second open-label stage, all study participants received SPL026 treatment, and were followed-up for a further three months in study, and continued to be followed up out-of-study to six months following the open-label dose, enabling further assessment of durability of antidepressant effect using the Montgomery-Asberg Depression Rating Scale (MADRS).
A total of 25 patients from both treatment arms (single and two dose regimen) completed the six-month patient follow-up.
Of the 25 patients who completed the six-month patient follow-up 14 patients had initially achieved remission1 within the three-month in-study period (“Prior Remitters”), nine of the Prior Remitters (64%) sustained remission at six-months and overall, 10 of the 25 patients (40%) met the criteria for remission at six-months
Dr. Carol Routledge, Chief Medical & Scientific Officer said: “With our ongoing analyses of the Phase IIa trial data, we are increasingly encouraged by the treatment potential of SPL026. A single dose in conjunction with therapy demonstrated a rapid and robust antidepressant effect after one week.
“This new data shows that the antidepressant effect was sustained for six months in two-thirds of patients who were in remission at an earlier time-point in the study.
“As we finalise the design of the Phase 2b study, this data helps to inform our understanding of treatment durability and our approach to patient re-treatment within the trial.”
Robin Carhart-Harris PhD, Director of the Psychedelics Division at the Weill Institute for Neurosciences at the University of California San Francisco, and Ralph Metzner, Distinguished Professor of Neurology, Psychiatry and Behavioral Sciences, commented: “This data indicates that SPL026 can elicit a fast-acting antidepressant response that appears to be enduring in several cases.
“Recent neuroimaging and preclinical findings imply a regenerative action with DMT and other related serotonergic agonists.”
