Mindbio talks initial MB22001 phase 2B trial results

Executive Summary

• Mindbio Therapeutics reported that repeated microdosed LSD (MB22001) did not demonstrate superiority over placebo in reducing depression severity (MADRS) after eight weeks (p = 0.5469).
• Safety profile was favourable with only mild adverse events; no serious adverse events occurred in the LSD arm.
• The company highlighted ongoing AI‑driven product development (Booze AI app) and noted positive mood‑elevating effects of microdosed LSD in healthy individuals, though not therapeutic for MDD.

Key Details

• Trial Design: Single‑site, randomized, double‑dummy, placebo‑controlled Phase 2B; 89 participants with MDD; dosing twice weekly (8–20 µg LSD) vs active placebo (caffeine).
• Baseline Characteristics: Mean age 38.3 ± 10.3 years; 60 % female (53/89).
• Group Allocation: LSD n = 44; Placebo n = 45.
• MADRS Scores – Baseline:
• LSD: 23.6 ± 6.5
• Placebo: 23.0 ± 6.4
• MADRS Scores – Week 8:
• LSD: 16.6 ± 8.1 (29.9 % reduction)
• Placebo: 14.6 ± 8.6 (36.4 % reduction)
• Statistical Outcome: No significant difference between groups at week 8 (p = 0.5469).
• Adverse Events – Frequency (n, %):
• Abdominal pain/digestive issues: Placebo 10 (22 %), LSD 13 (29 %)
• Blood pressure/cardiovascular issues: Placebo 11 (25 %), LSD 12 (27 %)
• Headache: Placebo 10 (22 %), LSD 9 (20 %)
• Serious Adverse Events: None reported in LSD arm.
• Interpretation: Repeated microdosed LSD is ineffective for treating MDD; however, dose‑day‑related mood improvements were observed in healthy subjects.
• Future Directions: Data will inform continued product development and AI/ML initiatives, including expansion of the Booze AI app for alcohol intoxication detection via speech analysis.

Notable Quotes

(No direct quotes provided in the release.)