MindBio Therapeutics Corp. is advancing its clinical trials involving microdosing of Lysergic Acid Diethylamide (LSD) for mental health conditions. CEO Justin Hanka provided a video update to shareholders, highlighting the progress of ongoing trials and results from completed studies. The company has successfully completed Phase 1 and Phase 2a clinical trials, revealing positive outcomes and new discoveries related to the use of MB22001.
Phase 2a Trial Results
In February 2024, MindBio concluded its Phase 2a trial of MB22001 in patients diagnosed with Major Depressive Disorder (MDD). The open-label trial demonstrated a substantial 60% reduction in depressive symptoms among participants. Furthermore, 53% of patients with MDD achieved remission by the eighth week of the trial. The mean reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) score was 14.1 points, indicating a clinically significant improvement.
Prior trial results with MB22001 also indicated statistically significant improvements in total sleep time and sleep quality. Participants reported increased subjective feelings of happiness, social connectivity, energy, creativity, and wellness, alongside reduced anger and irritability.
Notably, the antidepressant response was sustained at one and three months following the completion of the eight-week treatment cycle. These findings suggest that MB22001 holds promise as a potential market-disrupting medicine for treating depressive illnesses.
Ongoing Phase 2B Clinical Trials
MindBio is currently conducting two Phase 2B clinical trials, with dosing underway. Additionally, a third Phase 2B trial has been approved, focusing on women’s health. These trials are notable as world-firsts, approved for the take-home use of MB22001, a proprietary and self-titratable form of LSD designed for safe microdosing.
According to MindBio, only a few public companies globally have advanced to Phase 2 and Phase 3 clinical trials in psychedelic medicines. MindBio claims to be the most advanced clinical trial stage biopharmaceutical company listed on the Canadian Securities Exchange and the only company at this level not listed on a senior exchange.