Small Pharma Announces Positive Six-month Data from Phase IIa Trial of SPL026
April 04, 2023 at 07:30 AM EDT
LONDON, April 04, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, today announces positive six-month data from the Company’s Phase IIa clinical trial of SPL026. In the study, patients with Major Depressive Disorder (“MDD”) received SPL026, the Company's proprietary, pharmaceutical-grade formulation of N,N-Dimethyltryptamine (“DMT”), during a clinical session with supportive therapy. New data from the Phase IIa trial shows that among the patients who had achieved remission within three months with SPL026, 64% sustained remission to six months.
The trial investigated the efficacy and safety of 21.5mg intravenous (“IV”) SPL026 with supportive therapy in 34 patients with moderate/severe MDD. The study was conducted in two stages. The first stage 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 phase, all study participants received SPL026 treatment, and were followed-up for a further three months in study.
Patients 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:
The chart below sets out aggregated remission ratesa at one week to six months post open-label dose, demonstrating the remission rates of patients over time:
Note: n = number of datapoints
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 finalize the design of the Phase IIb study, this data helps to inform our understanding of treatment durability and our approach to patient retreatment within the trial.”
George Tziras, Chief Executive Officer of Small Pharma said: “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.”
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.”
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