Mr. Justin Hanka reports

MINDBIO THERAPEUTICS ANNOUNCES RESULTS FROM LANDMARK PHASE 2B MICRODOSING IN DEPRESSION TRIAL

Mindbio Therapeutics Corp. has completed its initial assessment of results from its recently completed phase 2B clinical trial in patients with Major Depressive Disorder (MDD).

Background

Theories suggest that repeatedly taking low doses of a psychedelic medicine (microdosing) may have benefits for mental health symptoms. This phase 2B trial aimed to determine the superiority of repeated microdosed LSD (lysergic acid diethylamide), also known as MB22001, a microdose of lysergic acid diethylamide, over placebo to treat MDD.

Prior to this trial, the company had sponsored two successfully completed trials: a phase 1 randomized, placebo-controlled trial in 80 healthy individuals and a second phase 2A open-label trial in 20 patients with MDD. The phase 1 trial yielded statistically significant dose-day-related elevations in mood, such as enhanced feelings of well-being, increased energy and feelings of social connectivity and creativity, and reduced irritability and anger. Statistically significant and clinically meaningful improvements in sleep were also noted. The phase 2A open-label trial in patients with MDD yielded a 60-per-cent reduction in depressive symptoms at the end of the trial and a 72-per-cent reduction in depressive symptoms sustained six months after treatment. The data from both these trials were sufficiently supportive of the company persisting to phase 2B trials.

The company's approach to data collection and utilization in clinical trials has led to many important discoveries. Notably, Mindbio made the groundbreaking speech and LSD prediction discovery in that the company can predict whether someone is microdosing LSD by using patient's speech. This has already led to the commercialization of the Booze AI app, which in turn has become a world-first prediction model for alcohol intoxication and blood alcohol concentration estimation using speech analysis over a smart phone.

Methods

This clinical trial was a single-site, randomized phase 2B clinical trial. Physically healthy adults with MDD and no history of psychotic disorders were included. Participants took 16 LSD or active placebo (caffeine) doses twice weekly, starting at eight micrograms of LSD and subsequently determined by a titration scheme (four to 20 micrograms) in a double-dummy design. Concurrent use of antidepressants was allowed, with no difference in response between antidepressant users and non-antidepressant users recorded. Participants were encouraged to engage in a self-selected beneficial activity when dosing. Participants, investigators and efficacy assessors were blinded to the allocation. Primary efficacy was depression severity measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at the eight-week point.

Findings

Eighty-nine people (mean age of 38.3 plus or minus 10.3 years; 53 (60 per cent) females) were randomized to placebo (n equal to 45) or LSD (n equal to 44). The placebo group had a MADRS score of 23.0 (standard deviation equal to 6.4) at baseline and 14.6 (standard deviation equal to 8.6) at eight weeks, presenting a 36.4-per-cent reduction. The LSD group had a MADRS score of 23.6 (standard deviation equal to 6.5) at baseline and 16.6 (standard deviation equal to 8.1) at eight weeks, presenting a 29.89-per-cent reduction. There was no effect of drug allocation on depression severity (MADRS) score at the eight-week time point (p equal to 0.5469).

The safety profile of LSD was favourable. Adverse event rates were low. The most frequent adverse events on dosing days were abdominal pain and digestive issues (placebo: 10 (22 per cent); LSD: 13 (29 per cent)), blood pressure and cardiovascular issues (placebo: 11 (25 per cent); LSD: 12 (27 per cent)), and headache (placebo: 10 (22 per cent); LSD: nine (20 per cent)). No serious adverse events occurred in the LSD arm, and the regimen was well tolerated.

Interpretation

Repeated microdosed LSD is not effective for treating major depressive disorder.

However, there is strong evidence to suggest that there are dose-day-related mood-elevating effects and improvements to sleep resulting from microdosed LSD in healthy individuals.

The data collected from clinical trials continue to inform the company's product development activities and the development of novel technologies using AI (artificial intelligence) and machine learning such as the Booze AI app, which has already advanced its first iteration into consumer sales and is working toward potential enterprise-level opportunities in drug and alcohol intoxication detection using speech analysis.

About Mindbio Therapeutics

Mindbio Therapeutics is a clinical-stage biotechnology company headquartered in Vancouver, B.C., that, for several years, has been conducting clinical trials and is focused on developing novel treatments for mental health disorders and health prediction technologies using AI and machine learning.

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