MindBio Therapeutics Announces Results from Landmark Phase 2B Microdosing in Depression Trail

Executive Summary

• MindBio Therapeutics completed its Phase 2B trial of microdosed LSD (MB22001) for Major Depressive Disorder; the study found no statistically significant difference versus placebo on MADRS scores.
• Safety profile was favourable with only mild adverse events and no serious events in the LSD arm.
• The company highlights ongoing AI‑driven product development, including the Booze AI app for speech‑based intoxication detection.

Key Details

• Trial Design: Single‑site, randomised, double‑dummy, placebo‑controlled Phase 2B; 89 participants (44 LSD, 45 placebo); dosing twice weekly with titrated microdoses (8–20 µg).
• Primary Endpoint: Change in Montgomery‑Åsberg Depression Rating Scale (MADRS) at eight weeks.
• Efficacy Results:
• Placebo: Baseline MADRS 23.0 (SD 6.4) → Week 8 MADRS 14.6 (SD 8.6), 36.4 % reduction.
• LSD: Baseline MADRS 23.6 (SD 6.5) → Week 8 MADRS 16.6 (SD 8.1), 29.9 % reduction.
• No statistically significant difference between groups (p = 0.5469).
• Safety Findings:
• Most frequent adverse events – abdominal pain/digestive issues (Placebo 22 %; LSD 29 %), blood pressure/cardiovascular issues (Placebo 25 %; LSD 27 %), headache (Placebo 22 %; LSD 20 %).
• No serious adverse events reported in the LSD arm; overall regimen well‑tolerated.
• Interpretation: Repeated microdosed LSD is not effective for treating MDD based on this trial.
• Additional Observations: Prior Phase 1 and Phase 2A studies showed mood‑elevating effects and sleep improvements in healthy participants, supporting continued exploration of microdose benefits outside the MDD indication.
• Technology Development: The company’s speech‑analysis AI platform (Booze AI) has moved to consumer sales and is pursuing enterprise applications for drug/alcohol intoxication detection.

Notable Quotes

“Repeated microdosed LSD is not effective for treating major depressive disorder. However, there is strong evidence to suggest dose‑day related mood elevating effects and improvements to sleep resulting from microdosed LSD in healthy individuals.” – Justin Hanka, CEO, MindBio Therapeutics

All forward‑looking statements are subject to the usual risk factors disclosed in the release.