Biomind Labs (OTCQB:BMNDF) has begun administering its proprietary second-generation psychedelic, BMND01, in a Phase 1/2a clinical trial for treatment-resistant depression (TRD).
The company administered the first subject with the DMT analog to evaluate the safety, pharmacokinetics, behavioral and brain effects of the molecule through inhalation. The team in charge of the study is led by Dr. Dráulio Araújo, Biomind’s scientific and clinical advisor.
“An inhaled formulation could allow DMT to be rapidly delivered directly into the systemic circulation, bypassing the first-pass metabolism, recognized as a major problem for some routes of DMT administration,” Araújo explained. “Due to the chosen inhaled route of administration, the DMT is likely to exert plenty of its potency in approximately ten minutes, which will allow more affordable interventions to be designed and implemented.”
The first part of the concentration-response study involves giving the drug to healthy subjects, but the later 2a phase will include “psychedelic-naïve” patients with TRD. The first part of the study, which includes 30 volunteers, is expected to be concluded in approximately four months.
Alejandro Antalich, CEO of Biomind, commented: “The company's new psychedelic therapeutic model, as a psychiatry intervention-based approach, may allow a rapid and feasible merge of DMT therapy into clinical practices.”
