TORONTO—-Biomind Labs Inc. (“Biomind Labs” or the “Company”) (NEO: BMND), a leading biotech company in fast-acting psychedelics is pleased to announce that its Phase II clinical trial on N, N-dimethyltryptamine (“DMT”) for treatment-resistant depression has been approved by the Brazilian Institutional Review Board.
“A paramount step in our rapid evolution that positions us at the forefront of clinical research on the DMT molecule. DMT is an indole alkaloid found endogenously in various plant species and in humans, it is found primarily in the lungs, thyroid, adrenal gland, and in lower concentration in the brain. DMT provides the principal psychedelic in the Amazonian decoction, ayahuasca. According to a recent randomized placebo-controlled trial in patients with treatment-resistant depression conducted by our Neuroscientist Dr. Draulio Barros de Araujo, published in Psychological Medicine, ayahuasca is safe and presented a rapid antidepressant effect. This clinical trial is the first and the only completed randomized placebo-controlled trial to test a psychedelic substance in treatment-resistant depression. The results of this trial were crucial for Biomind Labs to be able to advance with an isolated form of DMT”, said Alejandro Antalich, CEO of Biomind Labs.
The Phase II clinical trial will be conducted by Dr. Draulio Barros de Araujo, will include 40 individuals and will be conducted in Brazil. Given the safety profile, the absence of overdose, tolerance and previous results with ayahuasca, Biomind Labs continues to reinforce the Molecule Clinical Development Dossier of its novel pharmaceutical BMND01, enabling a potentially successful molecule-to-market lifecycle.
“Approximately 20-30% of people with depression have inadequate responses to antidepressants and psychotherapies, even after multiple interventions. Treatment-resistant depression places great demands on healthcare resources and on patients, many of whom attempt and die by suicide. This scenario makes the search for new treatments a necessity. Clinical trials carried out in recent years have shown rapid antidepressant responses to psychedelic substances. Our scientific team is a pioneer in conducting clinical trials, using open and randomized designs with psychedelic substances in patients with treatment-resistant depression”, commented Dr. Draulio Barros de Araujo.
“We believe that DMT possesses a number of benefits in comparison to other tryptamine compounds such as psilocybin. This includes a short psychedelic experience with a duration of less than 30 minutes compared to other psychedelic compounds, including psilocybin, whose duration of experience typically lasts six hours, LSD typically lasts ten hours and ayahuasca four hours. The significant reduction in experience duration provides greater practical applicability to potentially deliver the psychedelic treatment in a supervised real-world clinical setting. This is also highly relevant to affordability, one of our core objectives. While establishing a close relationship with the psychiatry community, government authorities and health agencies, we are working towards a potentially massive and affordable solution for millions of patients suffering from depression, anxiety and eating disorders, among others”, concluded Antalich.
