MindBio Therapeutics (CSE:MBIO; Frankfurt:WF6) received its first batch of MB22001 ready for take-home use in Phase 2 psychedelic microdosing clinical trials.
MB22001 is a proprietary titratable form of lysergic acid diethylamide (LSD) designed for safe and effective take home microdosing in patients suffering from major depressive disorder. Ethics committee approval and clinical trials registry approvals have already been received.
In a statement, MindBio CEO Justin Hanka, said that “assuming we start dosing patients prior to September, we should have top line results data to share with the market later in the year.”
LSD-microdosing clinical trials to date 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.”
MindBio has two fully funded Phase 2 LSD-microdosing clinical trials starting shortly. The first trial focuses on major depressive disorder, where 20 patients meeting DSM-V criteria will receive an open label eight-week LSD microdosing treatment regimen in an at-home setting. The 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 LSD-microdosing in conjunction with “meaning centered 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 recruiting participants shortly.
