ATAI - Intranasal 5-MeO-DMT Clinical Trial Offers Hope For Treatment-Resistant Depression | Benzinga
Partners Beckley Psytech and atai Life Sciences (NASDAQ:ATAI) have jointly announced positive initial results from a Phase 2a study of Beckley's novel formulation of 5-MeO-DMT in Treatment Resistant Depression (TRD.)
See: Atai Invests $50M In Beckley Psytech For Short-Duration Psychedelics Development
BPL-003 is a synthetic and patent-protected benzoate salt formulation of 5-MeO-DMT (aka mebufotenin) designed for intranasal administration. The open-label study assessed safety, tolerability and efficacy of the compound at a single 10mg dose, alongside psychological support, in patients with moderate-to-severe TRD (who withdrew from concomitant antidepressants.)
The study's initial findings reflect treatment of 11 participants, who were followed for 12 weeks post-dosing. Efficacy was assessed using the widely known and accepted Montgomery–Åsberg Depression Rating Scale (MADRS.)
The single 10mg dose resulted in a rapid onset and durable antidepressant effect in patients with TRD, which affects approximately 100 million people worldwide. Importantly, these findings are believed to represent the longest known follow-up of depression outcomes in a clinical study of 5-MeO-DMT.
Specifically:
- BLP-003's single dose induced a rapid antidepressant response in 55% of patients on the day after dosing. The antidepressant effect lasted, with a 55% response rate maintained at Week 4 and further on to Week 12.
- 55% of patients were in remission at Week 4, ...