BiomindLabs Receives Approval for a Second Phase II Clinical Trial forTreatment-resistant Depression
09 Mar 2022
Depressive Disorder, Treatment-ResistantDimethyltryptamine
Biomind Labs Inc. (“Biomind Labs” or the “Company”) (NEO: BMND) (OTC: CRSWF) (FSE: 3XI), a leading biotech company focused on innovation and research on endogenous tryptamines (biomolecules acting as psychoneuroplastogens) for the treatment of mental health disorders and beyond, is pleased to announce that its second Phase II clinical trial on N, N-dimethyltryptamine (“DMT”) for treatment-resistant depression has been approved by the Brazilian Institutional Review Board (the “IRB”).
“Just a few months ago, we announced the approval of our first Phase II clinical trial with an intramuscular formulation of DMT for treatment-resistant depression. Today with great enthusiasm we announce the IRB’s approval of our second Phase II clinical trial with an inhaled formulation of DMT, which will may allow us to identify the most effective method of administration for our DMT candidate in patients with depression”, commented Alejandro Antalich, CEO of Biomind Labs.
“The effects of intramuscular DMT last for about one hour, while the inhaled formulation is expected to shorten these effects to a timeframe between ten to fifteen minutes. Our goal is to find significant antidepressant effects with the shortest experience, pursuing one of our main pillars as a company, affordability. Our goal is to develop effective and safe novel pharmaceuticals that are affordable to patients regardless the income level. We understand that the long-lasting psychedelic effects make it difficult to create adequate clinical protocols to serve a larger number of patients, and this is the main reason why we focus on fast-acting psychedelics”, concluded Antalich.
In this second Phase II clinical trial, the Company will test a new approach of psychedelic therapies, a psychiatry intervention-based model, allowing a rapid and feasible merge of fast-acting psychedelic medicines into clinical practices already in existence. Consequently, provided that this second Phase II clinical trial is successful, such practices may receive a new tool, allowing practitioners to prescribe their patients specialized psychedelic medicines that may boost ongoing treatments.
This second Phase II clinical trial is scheduled to begin in the upcoming weeks. The trial will be conducted by the Company’s Scientific and Clinical Advisor Neuroscientist Dr. Dráulio Araújo and will include 40 individuals. Given the safety profile, the absence of overdose, tolerance and previous results from the first randomized, placebo-controlled trial to test a psychedelic substance in treatment-resistant depression led by Dr. Araújo, Biomind Labs continues to reinforce the Molecule Clinical Development Dossier of its novel pharmaceuticals, enabling a potentially successful molecule-to-market lifecycle while minimizing the risks of failure.
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