Biomind Labs just hit a landmark on a trip that it hopes will take it all the way to market, posting new data that shows its inhaled psychedelic candidate aimed at helping patients with depression is safe and tolerable.
The candidate, called BMND01, is a liquid inhaled formulation of N,N-Dimethyltryptamine, otherwise known as DMT—a hallucinogen that is sometimes used as a recreational psychedelic drug. The 30-person phase 1 study evaluated the clinical and psychiatric risks in healthy volunteers, touting five primary goals: adverse event frequency, blood pressure, heart rate, respiratory rate and oxygen saturation.
While no specific data points were shared in the Nov. 4 release, the Canadian biotech’s head of psychiatric research Marcelo Falchi, M.D., commented that only a mild, transient and self-limited increase in blood pressure and heart rate of up to 30% compared to baseline values was observed. The increase is comparable to moderate physical activity in healthy individuals, Falchi added.
The trial tested 11 different doses of BMND01, ranging from 5 mg to 100 mg, and found no serious adverse events or clinical risk at any level.
“This is the world's first in-lab study using an inhaled formulation of DMT, and the largest completed trial with this molecule,” Biomind CEO Alejandro Antalich said in the release. The biotech is trying to cut down the length of time psychedelic sessions can take as a potential novel treatment for mental health disorders, he explained.
“This trial aims to go through the full psychedelic experience in just 10 minutes,” Antalich said. “These successful first results bring strong potential for the next phase of the trial, which will address patients suffering from treatment-resistant depression.”
Founded in 2020, Biomind is taking aim at neurological and psychiatric disorders using psychedelic molecules DMT, 5-MeO-DMT and mescaline. The company clearly has some momentum behind it, with former FDA director Thomas Laughren, M.D., joining the biotech’s team in July to serve as medical adviser for clinical trials.