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MindBio Therapeutics Corp. Begins Dosing Mb22001 in Phase 2 Clinical Trial in World’s First Take-Home Microdosing Study in Patients with Depression

MindBio Therapeutics Corp. (CSE:MBIO) announce the first doses of MB22001 have been administered to patients in this landmark microdosing study in depressed…



MindBio Therapeutics Corp. (CSE:MBIO) announce the first doses of MB22001 have been administered to patients in this landmark microdosing study in depressed patients.

This trial is a world first and remains the only clinical trial in the world to be approved for take-home use of LSD.

MB22001 is MindBio’s proprietary titratable form of Lysergic Acid Diethylamide (LSD) designed for safe and effective take home microdosing in patients suffering from Major Depressive Disorder. The microdose of this psychedelic medicine is sub-hallucinogenic and is taken every third day for 8 weeks in this open label Phase 2a clinical trial in 20 participants. This Phase 2a clinical trial is designed to test the feasibility, tolerability and effectiveness of MB22001 microdosing in patients with Major Depressive Disorder.

The trial will form the basis for continuing a much larger Phase 2b randomized triple dummy controlled trial in depressed patients. MindBio’s clinical trials of MB22001 have already yielded positive top line data in healthy individuals. The results of MindBio’s Phase 1 randomized controlled trial in 80 healthy participants produced surprising sleep data from over 3200 days of sleep recording an average 24 minutes of additional total sleep time and 8 minutes of additional REM sleep the day after dose days.

The landmark trial in healthy individuals also produced statistically significant enhancements in subjective feelings of “wellness”, “creativity”, “happiness”, “social connectivity” and “energy” on dose days. Participants in the MB22001 microdosing group also reported statistically significant feelings of being less “angry” and less “irritable”. MindBio is working towards the commercialization of microdosing treatments with a package of proprietary solutions for safe and effective at home use of psychedelics.

MindBio remains the only organization in the world approved for take-home use of LSD-Microdosing in clinical trials. The take home approvals are vital for testing the ecological validity of MindBio’s proprietary solutions as the Company progresses its commercialization strategy for global regulatory approvals. MindBio’s investment thesis, using microdosing, centers on the creation of a unique treatment model that is globally scalable, safe, accessible, and affordable, aiming to address the existing challenges in mental health care and also caters for the diversity of medical regulatory regimes around the world.

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