Next-Gen Psychedelic Delivers Promising Results For Treatment-Resistant Depression In Phase 2 Clinical Trial

Psychedelics biotech company Biomind Labs Inc. BMNDF has announced positive initial results from part 1 of a Phase 2 clinical trial on its proprietary liquid inhaled formulation of DMT, BMND01, designed for Treatment-Resistant Depression (TRD).

Through its R&D acceleration platform, Biomind Labs is developing novel formulations of the main psychedelic molecules DMT, 5-MeO-DMT and mescaline for the treatment of a wide range of therapeutic indications.

With this goal in sight and further expanding on the study, CEO Alejandro Antalich commented: “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.” 

As Antalich explained, this trial aims to deliver the full psychedelic experience within 10 minutes. In view of the successful results regarding BMND01’s safety and efficacy on 30 healthy volunteers, Biomind’s CEO believes the trial’s next phase, which will address patients suffering from TRD, holds a strong potential.

The Study And Outcomes

Led by professor Dráulio Araújo, Ph.D., the Phase 2 open-label clinical trial involved a dose exploration schedule ranging from 5 to 100 mg. Importantly, there were no cases of 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”, explained Biomind’s head of the psychiatric research unit Dr. Marcelo Falchi.

Dr. Falchi sees excellent clinical potential and safety in DMT and referred to the substance as “the only endogenous psychedelic molecule which is already present in low concentrations in different organs of the human body.”

The study’s experimental design involved developing and implementing a novel protocol based on the fundamentals of interventional psychiatry. The result is a multidisciplinary approach combining a psychiatric procedure for dosing DMT together 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,” CEO Antalich concluded.

Photo courtesy of Pavel Danilyuk on Pexels and Harbin on Wikimedia Commons.