Small Pharma has reported positive results from a Phase IIa clinical trial of SPL026, a pharmaceutical-grade formulation of DMT, in treating Major Depressive Disorder.
New clinical trial results for a proprietary formulation of N, N-Dimethyltryptamine (DMT) developed by biotech company Small Pharma have shown promise in treating major depressive disorder (MDD), according to a recent press release.
Small Pharma is a biotechnology company that specializes in developing short-duration psychedelic-assisted therapies for mental health conditions. They recently conducted a Phase IIa clinical trial of SPL026, which is a pharmaceutical-grade formulation of DMT. The trial aimed to investigate the safety and efficacy of SPL026 in treating MDD.
DMT is a naturally occurring psychedelic substance that is found in some plants and animals, including humans. It is known for producing intense and often profound psychological effects, which can include vivid and highly realistic visionary experiences that can be both challenging and transformative.
DMT has been used for thousands of years in traditional shamanic practices in South America, where it is typically consumed as part of an ayahuasca brew and other indigenous plant medicines. In recent years, there has been growing interest in the potential therapeutic uses of DMT, particularly in the context of psychedelic-assisted psychotherapy.
In the study, 34 patients with moderate/severe MDD received a 21.5mg intravenous (IV) dose of SPL026 in conjunction with supportive therapy. An IV dose refers to a method of administering DMT directly into the bloodstream through a vein, which allows for precise dosing and rapid onset of the drug’s effects.
The trial 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.
After the open-label dose, the patients were monitored for an additional six months outside of the formal study setting. This follow-up period was used to assess the longer-term effects of the drug on the patient's symptoms and overall well-being, and further assess the durability of the drug’s antidepressant effect using the Montgomery-Asberg Depression Rating Scale (MADRS).
MADRS is a standard questionnaire used to assess the severity of depression symptoms. It consists of 10 items that measure mood, feelings of guilt and worthlessness, suicidal ideation, sleep, appetite, and other factors that are commonly affected by depression. A higher score on the MADRS indicates more severe depression.
Among the patients who had achieved remission within three months with SPL026, 64% sustained remission to six months. Specifically, 14 patients had initially achieved remission within the three-month in-study period, and 9 of those patients (64%) sustained remission at six months. Overall, of the 25 patients who completed the six-month follow-up, 10 (40%) met the criteria for remission.
Small Pharma’s trial of SPL026 demonstrates promising results in the treatment of Major Depressive Disorder. As Dr. Carol Routledge, Chief Medical & Scientific Officer of Small Pharma, notes, "We are increasingly encouraged by the treatment potential of SPL026," and the sustained remission demonstrated in two-thirds of patients is particularly notable.
Furthermore, as George Tziras, Chief Executive Officer of Small Pharma, suggests, these results could offer potential value to healthcare systems facing challenges with patient adherence to daily antidepressant use.
However, it's important to note that only 25 of the initial 34 patients completed the six-month follow-up period, and there was no placebo group for comparison. While the results are promising, larger studies with more rigorous controls are needed, which could further validate the safety and efficacy of SPL026 as a treatment for MDD.
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