MindBio Therapeutics Corp. reported it has made a major discovery from genetic testing clinical trial participants in the largest LSD-Microdosing randomized double blind and placebo-controlled trial ever completed. The data analysis comes as the Company begins two Phase 2 clinical trials using its proprietary form of LSD for Microdosing MB22001.
These trials are a world first, the only clinical trials in the world to be approved for take-home use of LSD. The genetic data collected adds to MindBio’s intellectual property in a Big Data play for the Company. Understanding the effect of genotype in treating patients is a significant advantage for predicting patient vulnerability to medication and likelihood of success and or adverse reactions.
MindBio’s novel discovery adds to it’s capabilities for modelling effective treatment in patients. MindBio is developing a treatment methodology using microdoses of MB22001 to treat patients with depression. MindBio’s clinical trials have yielded positive top line data such as improved quality of sleep including REM and total time of sleep and statistically significant enhancements in subjective feelings of “wellness”, “creativity”, “happiness”, ” social connectivity” and “energy”.
Participants in the LSD-Microdosing group also reported statistically significant feelings of being less “angry” and less “irritable”. The Company has made several novel discoveries during clinical trials and is collecting the largest repository of LSD-Microdosing data ever compiled through randomized controlled trials in a series of world first take-home trials. The Company has cast its research broadly to amass data across a large battery of psychometric, biometric, physiological and qualitative data that is collected in the laboratory in a full day first session with trial participants and then collected 24 hours a day for 8 weeks at home.
In a Big Data strategy for the Company, 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 the 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 has two fully funded Phase 2 LSD-Microdosing clinical trials and its Phase 2a trial in depressed patients has just started dosing. This trial focuses on Major Depressive Disorder, where 20 patients meeting DM-V criteria will receive an open label 8-week MB22001 microdosing treatment regimen in a naturalistic at-home setting. This trial will serve as the basis for continuing a much larger Phase 2b triple-dummy, active placebo-controlled trial in depressed patients.
The second trial explores the effectiveness of MB22001 in conjunction with Meaning Centred Psychotherapy in late-stage cancer patients experiencing emotional distress. This randomized, double-blind, and placebo-controlled trial will involve 40 participants and is set to begin in the coming weeks.