November 13, 2025 — Leads & Copy —
Vancouver, British Columbia – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6) has completed its initial assessment of results from its Phase 2B clinical trial in patients with Major Depressive Disorder (MDD). The biotechnology company is focused on clinical health research and product development.
The Phase 2B trial aimed to determine if repeated microdosed LSD, also known as MB22001, is better than a placebo for treating MDD.
MindBio had previously sponsored two trials: a Phase 1 randomised, placebo-controlled trial in 80 healthy individuals and a Phase 2A open-label trial in 20 patients with MDD. The Phase 1 trial showed statistically significant dose-day-related elevations in mood, such as enhanced feelings of well-being, increased energy, social connectivity, creativity, and reduced irritability and anger. The Phase 2A trial in MDD patients resulted in a 60% reduction in depressive symptoms at the end of the trial and a 72% reduction sustained six months post-treatment. The prior data supported the Phase 2B trials.
The clinical trial was a single-site, randomized phase 2B clinical trial. Participants with MDD, but no history of psychotic disorders, took 16 LSD or active placebo (caffeine) doses twice weekly, starting at 8 µg of LSD, subsequently determined by a titration scheme (4 – 20 µg) in a double-dummy design. Concurrent use of antidepressants was allowed with no difference in response recorded between antidepressant users and non-antidepressant users. Participants were encouraged to engage in a self-selected beneficial activity when dosing. Depression severity was measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at the eight-week point.
Eighty-nine people were randomized to placebo (n = 45) or LSD (n = 44). The placebo group had a MADRS score of 23.0 (SD = 6.4) at Baseline and 14.6 (SD = 8.6) at eight weeks, presenting a 36.4% reduction. The LSD group had a MADRS score of 23.6 (SD = 6.5) at baseline and 16.6 (SD = 8.1) at eight weeks, presenting a 29.89% reduction. There was no effect of drug allocation on depression severity (MADRS) score at the eight-week time-point (p = 0.5469).
The safety profile of LSD was favorable. Adverse event rates were low. The most frequent adverse events on dosing days were abdominal pain and digestive issues (placebo n [%]; LSD n [%]: 10 [22%]; 13 [29%]), blood pressure and cardiovascular issues (11 [25%]; 12 [27%]), and headache (10 [22%]; 9 [20%]). No serious adverse events occurred in the LSD arm, and the regimen was well-tolerated.
The company says that repeated microdosed LSD is not effective for treating major depressive disorder. However, prior data suggests dose-day-related mood-elevating effects and improvements to sleep resulting from microdosed LSD in healthy individuals.
Data collected from clinical trials continues to inform the company’s product development activities and the development of technologies using AI and machine learning, such as the Booze AI app app.booze-ai.com, which is being developed for drug and alcohol intoxication detection using speech analysis.
Justin Hanka, Chief Executive Officer, 61 433140886, justin@mindbiotherapeutics.com
Source: MindBio Therapeutics Corp.
