Biomind Labs Doses First Subject in Phase I/IIa Clinical Trial of Its DMT-Based Inhaled Formulation BMND01 for Treatment-Resistant Depression
The Phase I/IIa clinical trial on Biomind's first innovative formulation of N,N-Dimethyltryptamine (“DMT”) is evaluating the safety, pharmacokinetics, behavioral and brain effects of BMND01, for inhaled administration. The trial has commenced on time and as scheduled and is being administered by superior medical practices at Biomind's new clinical psychedelic research facility in the University Hospital Onofre Lopes. Led by Dr. Dráulio Araújo, Biomind’s Scientific and Clinical advisor, the team is a renowned group of scientists that conducted the first randomized placebo-controlled trial with ayahuasca for treatment-resistant depression.
This study is the world’s first clinical trial to test an inhaled formulation of DMT, Biomind’s novel drug candidate BMND01. The trial is designed with a fixed ascending two dose, concentration-response study, initially in healthy volunteers, followed by the Phase IIa portion of the study that will administer the formulation in psychedelic-naïve patients with treatment-resistant depression. This first phase of the study includes up to thirty healthy patients and dosing is expected to be completed in approximately four months.
"An inhaled formulation could allow DMT to be rapidly delivered directly into the systemic circulation, bypassing the first-pass metabolism, recognized as a major problem for some routes of DMT administration. Due to the chosen inhaled route of administration, the DMT is likely to exert plenty of its potency in approximately ten minutes, which will allow more affordable interventions to be designed and implemented," commented Dr. Dráulio Araújo.
Alejandro Antalich, CEO of Biomind Labs, said: “The Company's new psychedelic therapeutic model, as a psychiatry intervention-based approach, may allow a rapid and feasible merge of DMT therapy into clinical practices. Our intervention model has the capacity to be more easily integrated into existing mental health clinics worldwide, which will democratize the access to significantly more patients than the traditional psychedelic assisted therapy model.”
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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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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Biomind Labs Inc.
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Source: Biomind Labs Inc.