Our Results

SPL026 Phase IIa study in Major Depressive Disorder

In January 2023 we shared the positive results of our Phase IIa proof-of-concept study investigating SPL026 for the treatment of Major Depressive Disorder (MDD). This was the first blinded, placebo-controlled efficacy study to date exploring a short-duration psychedelic for depression. The trial investigated the safety and efficacy of intravenous SPL026 with supportive therapy in 34 patients with moderate/severe MDD. Efficacy was assessed using the Montgomery-Asberg Depression Rating scale (MADRS) to measure any potential change in patients’ depression from baseline.

The highlights from the study are:



SPL026 Phase I Healthy Volunteer Study

We completed a Phase I study in healthy volunteers as part of the combined Phase I/IIa clinical trial of SPL026 with supportive therapy for the treatment of Major Depressive Disorder. The study, which was conducted at Hammersmith Medicines Research in collaboration with Imperial College London, was a dose-escalating, placebo-controlled Phase I study in 32 healthy psychedelic-naïve volunteers across four cohorts who received either SPL026 (n=24) or placebo (n=8) with supportive therapy.

The study demonstrated that intravenous (IV) administration of SPL026 offers a short-lived, well-tolerated psychedelic experience of ~20 minutes. In the three-month study period, no serious adverse events were reported and minimal mild, short-lived adverse events that were resolved spontaneously on dosing day.

The results of the study were presented at the European College of Neuropsychopharmacology (ECNP) Congress in October, 2022. A poster presentation was also delivered at the CNS Summit in November, 2022. 

SPL028 Data From Preclinical Studies

Here we present data on the preclinical characterisation of deuterated (d-)DMT analogues, which are hypothesized to prolong the duration of the psychedelic experience. These effects may offer clinical advantage for some patient groups and for additional psychiatric disorders.

Small Pharma talks

According to the Royal College of Psychiatry, mental illness is likely to be the second pandemic.

Watch our Chief Medical and Scientific Officer, Dr Carol Routledge, chat with Alastair Campbell as they discuss depression, DMT-assisted therapy and the future of treatments for mental health.

About Small Pharma

We’re a biotechnology company researching and developing short-acting psychedelics with supportive therapy for mental health conditions.

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