The open-label, ascending dose trial analysed the safety and tolerability of the drug candidate and protocol in 30 healthy subjects.
It had a dose exploration schedule ranging from 5mg to 100mg.
The trial’s experimental design comprised the development and deployment of a clinical-experimental protocol based on interventional psychiatry’s fundamentals.
This multidisciplinary strategy merged a psychiatric process for dosing N,N-Dimethyltryptamine (DMT) linked with psychological support under stringent clinical standards.
According to the initial data, no trial subject experienced serious adverse events or clinical risk to the 11 varying doses of the therapy assessed.
A mild, temporary, and self-limited rise in blood pressure and heart rate of up to 30% versus baseline values were observed in the study, without any clinical consequences.
This is claimed to be a physiological rise similar to moderate physical activity in healthy people.
The initial successful data provides a robust potential for the subsequent phase of the trial in patients with TRD.
BMND01 is a liquid inhaled formulation of DMT.
Biomind Labs CEO Alejandro Antalich said: “The model is intended to integrate into existing health systems globally, quickly, and easily, positioning Biomind Labs’ BMND01 candidate at the frontier of accessible psychedelic medicine.
“By allowing the creation of specialised centres for the administration of DMT, it is possible to scale-up treatments, without the need to train a whole new generation of mental health professionals.”
In September this year, the company concluded the dosing of the 30 healthy subjects in the Phase II trial of BMND01 for TRD.