TORONTO--(BUSINESS WIRE)--Biomind Labs Inc. (“Biomind Labs” or the “Company”) (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”, commented 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.
The trial is registered at www.clinicaltrials.gov (NCT05573568).
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.
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By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors and risks include, among others: (a) the Company may require additional financing from time to time in order to continue its operations which may not be available when needed or on acceptable terms and conditions acceptable; (b) compliance with extensive government regulation; (c) domestic and foreign laws and regulations could adversely affect the Company’s business and results of operations; (d) the stock markets have experienced volatility that often has been unrelated to the performance of companies and these fluctuations may adversely affect the price of the Company’s securities, regardless of its operating peers; (e) adverse changes in the public perception of tryptamine-based treatments and psychedelic-based therapies; (f) the impact of COVID-19; and (g) general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release.
The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding tryptamine-based treatments, psychedelic-based therapies or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psychedelic tryptamines, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not yet completed commercial clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that the Company verified such in commercial clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
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