No sign of significant negative effects on anxiety and wellbeing following pioneering Small Pharma trial

The world’s first clinical trial for dimenthyltryptamine (DMT)-assisted therapy has completed phase 1. In a notable milestone for Small Pharma, the company has shared data evaluating the use of psychotherapy for the treatment of major depressive disorder (MDD).

The trials also identified no statistically significant negative effects on anxiety and wellbeing during the three months of follow-up, alongside no drug-related serious adverse events. Minimal and short-lived adverse events were reported on dosing day.

“Psychedelic-assisted therapies have the potential to completely change the treatment paradigm of mental health conditions,” David Erritzoe of Imperial College London, chief investigator of the phase 1/2a study, said. “The additional insights from Small Pharma’s phase 1 study show promising results at this stage of the development.

“The dosing time of 30 minutes, in comparison with up to six hours seen with alternative approaches, has the potential to offer a real benefit in terms of treatment regimen for both patients and providers,” Erritzoe added.

Of 20 drug-related adverse events, all were mild (85%), or moderate (15%) and resolved rapidly and independently. Trial data also reveals that SPL026 is a scalable treatment option for MDD.

Dr Carol Routledge, chief medical and scientific officer of Small Pharma commented: “Given the subjectivity of the psychedelic experience, it was exciting to see a close correlation between levels of drug in the body and pharmacodynamic endpoints. As for the subjects’ experience, most reported that it was pleasurable, not too challenging and most importantly, nobody expressed any regrets.”

Small Pharma is a neuroscience company focused on psychedelic-assisted therapies for mental health conditions, with a focus on depression and initiated a clinical programme evaluating DMT-assisted therapy in February 2021.

DMT is a naturally occurring psychedelic found in plants and in the brain of mammals. Scientific evidence suggests it offers the potential for rapid-acting and long-lasting antidepressant effects.

DMT is particularly promising as a potential treatment due to its short psychedelic experience – less than 30 minutes – allowing for shorter treatment sessions and offering the potential for convenient supervised treatments.