Small Pharma Announces Positive Six-month Data from Phase IIa Trial of SPL026
– Approximately two-thirds of trial patients with Major Depressive Disorder achieving remission following SPL026 treatment sustained remission to six-months
April 4, 2023 – London, United Kingdom –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:
- 14 patients had initially achieved remission1 within the three-month in-study period (the “Prior Remitters”)
- 9 of the Prior Remitters (64%) sustained remission at six-months
- Overall, 10 of the 25 patients (40%) met the criteria for remission at six-months
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
(a) Aggregated data includes all participants who received either one dose or two doses of SPL026; and includes four participants excluded from the formal statistical analysis who received a blinded dose of SPL026 but did not receive a second open label dose.
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.”
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-duration psychedelic-assisted therapies for the treatment of mental health conditions. The Company’s current focus is on exploring new therapeutic approaches for depression. Small Pharma’s lead candidate, SPL026, is a proprietary synthetic formulation of DMT. The Company is advancing clinical programs of SPL026 and SPL028 with supportive therapy for the treatment of mental health conditions, and was granted an Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”) for IV SPL026 with supportive therapy for MDD. In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.
1 Remitters/remission: patients with MADRS score ≤10
For further information contact:
Small Pharma Inc.
George Tziras, Chief Executive Officer
Tel: +44 (0)7456 915968
Media Relations Contacts:
Tel/text: +44 (0)7720 326 847
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this news release include statements regarding the Company’s Phase IIa study of SPL026, including the six month data informing the Company’s understanding of treatment durability and approach to patient retreatment in the Phase IIb trial design; the impact of the data on the Company’s future clinical strategy and expansion of its clinical pipeline; the potential value of mental health treatments to healthcare systems and patients suffering from depression, and struggling with antidepressant use, including the Company’s ability to provide such treatments; and the Company’s ability to progress short-duration psychedelic assisted therapies for the treatment of mental health conditions.
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