Biomind Labs Inc. (NEO: BMND | OTC: BMNDF | FSE: 3XI), a leading biotech company focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological and psychiatric disorders by scientifically harnessing the medicinal power of psychedelic molecules, is pleased to announce positive initial results from part I of its Phase II trial on its BMND01 candidate, a novel liquid inhaled formulation of N,N-Dimethyltryptamine (“DMT”) for Treatment-Resistant Depression (“TRD”).
“With the conclusion of the dosing sessions, 30 volunteers went through the activities of the proprietary clinical-experimental protocol developed by our scientific team, to verify the safety and tolerability of our novel DMT-based candidate BMND01 and protocol in healthy individuals. This is the world’s first in-lab study using an inhaled formulation of DMT, and the largest completed trial with this molecule. We are seeking to tackle one of the most concerning factors related to psychedelics as a potential novel treatment for mental health disorders, the long duration of the sessions. This trial aims to go through the full psychedelic experience in just 10 minutes. These successful first results bring strong potential for the next phase of the trial, which will address patients suffering from TRD.”
Alejandro Antalich, CEO of Biomind Labs
The trial, led by Professor Dráulio Araújo, Ph.D., has involved a dose exploration schedule ranging from 5 to 100 mg. No volunteer presented serious adverse events or clinical risk to the 11 different doses tested. “During the trial, we observed only a mild, transient and self-limited increase in blood pressure and heart rate of up to 30% compared to baseline values, with no clinical repercussions. This is a physiological increase comparable to moderate physical activity in healthy individuals”, commented Marcelo Falchi, M.D., Biomind Labs’ Head of the Psychiatric Research Unit, who sees excellent clinical potential and safety in DMT, “the only endogenous psychedelic molecule, which is already present in low concentrations in different organs of the human body”, said Marcelo Falchi, M.D.
The experimental design of this open-label ascending dose trial involved developing and implementing a proprietary clinical-experimental protocol based on the fundamentals of interventional psychiatry. This multidisciplinary approach combines a psychiatric procedure for dosing DMT associated with psychological support under strict clinical standards. “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 specialized centers 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”, concluded Alejandro Antalich, CEO of Biomind Labs.
About Biomind Labs Inc
Biomind Labs is a biotech research and development company aimed at transforming biomedical sciences knowledge into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs is developing novel pharmaceutical formulations of the main psychedelic molecules DMT, 5-MeO-DMT and mescaline for treating a wide range of therapeutic indications. Biomind Labs’ focus is to provide patients access to affordable and modern-day treatments.